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1. The bio-sonographic index. A novel modality for early detection of acute kidney injury after complex vascular surgery. A protocol for an exploratory prospective study.

Author

Ahmed Zaky, Adam W Beck, Sejong Bae, Adam Sturdivant, Amandiy Liwo, Novak Zdenek, Nicole McAnally, Shama Ahmad, Brad Meers, Michelle Robbin, J F Pittet, Ashita Tolwani, and Dan Berkowitz

Subjects
Medicine, Science
Abstract

ObjectiveAcute kidney injury (AKI) is a common complication of complex aortic surgery with high mortality, morbidity and health care expense. The current definition of AKI does not allow for structural characterization of the kidneys and utilizes functional indices with substantial limitations leading to delayed diagnosis and ineffective interventions. The aim of this study is to develop a method of early detection of structural renal abnormalities that can precede and predict the occurrence of AKI in this population. We propose a novel combined index of ultrasonography (shear wave elastography), biomarkers of renal stress (urinary insulin growth factor binding protein-7, IGFBP-7 and inhibitor of tissue metalloproteinase-2, TIMP-2) and renal injury markers (urinary neutrophil gelatinase-associated lipocalin -NGAL)- the bio-sonographic index (BSI).MethodsA prospective observational study at a tertiary referral center will be performed enrolling 80 patients undergoing elective open and endovascular repair of the visceral aorta. The BSI will be evaluated at baseline, and at 6 and 24 hours after the procedure. The primary outcome is the occurrence of AKI according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria. Each patient will be his/her own control. A reference group of 15 healthy volunteers who are not undergoing interventions will be enrolled to test the feasibility of and to refine the novel SWE protocol. The BSI will be tested for its predictability of the occurrence of AKI. Comparisons will be made between individual and combined components of the BSI and traditional markers used in the KDIGO definition; serum creatinine and urine output in terms of baseline status of the kidney. Correlations will be made between the BSI and conventional indices of AKI and exploratory analyses will be conducted to identify individual disease patterns using the BSI.DiscussionWe hypothesize that the BSI will be a sensitive index of early structural abnormalities that precede and predict the occurrence of AKI as defined by KDIGO in complex vascular surgery.Trial registrationClinicalTrials.gov NCT04144894. Registered 1/6/2020.

Published
2020
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2. Pain, Analgesic Use, and Patient Satisfaction With Spinal Versus General Anesthesia for Hip Fracture Surgery : A Randomized Clinical Trial

Author

Mark D, Neuman, Rui, Feng, Susan S, Ellenberg, Frederick, Sieber, Daniel I, Sessler, Jay, Magaziner, Nabil, Elkassabany, Eric S, Schwenk, Derek, Dillane, Edward R, Marcantonio, Diane, Menio, Sabry, Ayad, Manal, Hassan, Trevor, Stone, Steven, Papp, Derek, Donegan, Mitchell, Marshall, J Douglas, Jaffe, Charles, Luke, Balram, Sharma, Syed, Azim, Robert, Hymes, Ki-Jinn, Chin, Richard, Sheppard, Barry, Perlman, Joshua, Sappenfield, Ellen, Hauck, Mark A, Hoeft, Ann, Tierney, Lakisha J, Gaskins, Annamarie D, Horan, Trina, Brown, James, Dattilo, Jeffrey L, Carson, Thomas, Looke, Sandra, Bent, Ariana, Franco-Mora, Pamela, Hedrick, Matthew, Newbern, Rafik, Tadros, Karen, Pealer, Kamen, Vlassakov, Carolyn, Buckley, Lauren, Gavin, Svetlana, Gorbatov, James, Gosnell, Talora, Steen, Avery, Vafai, Jose, Zeballos, Jennifer, Hruslinski, Louis, Cardenas, Ashley, Berry, John, Getchell, Nicholas, Quercetti, Gauasan, Bajracharya, Damien, Billow, Michael, Bloomfield, Evis, Cuko, Mehrun K, Elyaderani, Robert, Hampton, Hooman, Honar, Dilara, Khoshknabi, Daniel, Kim, David, Krahe, Michael M, Lew, Conjeevram B, Maheshwer, Azfar, Niazi, Partha, Saha, Ahmed, Salih, Robert J, de Swart, Andrew, Volio, Kelly, Bolkus, Matthew, DeAngelis, Gregory, Dodson, Jeffrey, Gerritsen, Brian, McEniry, Ludmil, Mitrev, M Kwesi, Kwofie, Anne, Belliveau, Flynn, Bonazza, Vera, Lloyd, Izabela, Panek, Jared, Dabiri, Chris, Chavez, Jason, Craig, Todd, Davidson, Chad, Dietrichs, Cheryl, Fleetwood, Mike, Foley, Chris, Getto, Susie, Hailes, Sarah, Hermes, Andy, Hooper, Greg, Koener, Kate, Kohls, Leslie, Law, Adam, Lipp, Allison, Losey, William, Nelson, Mario, Nieto, Pam, Rogers, Steve, Rutman, Garrett, Scales, Barbara, Sebastian, Tom, Stanciu, Gregg, Lobel, Michelle, Giampiccolo, Dara, Herman, Margit, Kaufman, Bryan, Murphy, Clara, Pau, Thomas, Puzio, Marlene, Veselsky, Kelly, Apostle, Dory, Boyer, Brenda Chen, Fan, Susan, Lee, Mike, Lemke, Richard, Merchant, Farhad, Moola, Kyrsten, Payne, Bertrand, Perey, Darius, Viskontas, Mark, Poler, Patricia, D'Antonio, Greg, O'Neill, Amer, Abdullah, Jamie, Fish-Fuhrmann, Mark, Giska, Christina, Fidkowski, Stuart Trent, Guthrie, William, Hakeos, Lillian, Hayes, Joseph, Hoegler, Katherine, Nowak, Jeffery, Beck, Jaslynn, Cuff, Greg, Gaski, Sharon, Haaser, Michael, Holzman, A Stephen, Malekzadeh, Lolita, Ramsey, Jeff, Schulman, Cary, Schwartzbach, Tangwan, Azefor, Arman, Davani, Mahmood, Jaberi, Courtney, Masear, Syed Basit, Haider, Carolyn, Chungu, Ali, Ebrahimi, Karim, Fikry, Andrew, Marcantonio, Anitha, Shelvan, David, Sanders, Collin, Clarke, Abdel, Lawendy, Gary, Schwartz, Mohit, Garg, Joseph, Kim, Juan, Caruci, Ekow, Commeh, Randy, Cuevas, Germaine, Cuff, Lola, Franco, David, Furgiuele, Matthew, Giuca, Melissa, Allman, Omid, Barzideh, James, Cossaro, Armando, D'Arduini, Anita, Farhi, Jason, Gould, John, Kafel, Anuj, Patel, Abraham, Peller, Hadas, Reshef, Mohammed, Safur, Fiore, Toscano, Tiffany, Tedore, Michael, Akerman, Eric, Brumberger, Sunday, Clark, Rachel, Friedlander, Anita, Jegarl, Joseph, Lane, John P, Lyden, Nili, Mehta, Matthew T, Murrell, Nathan, Painter, William, Ricci, Kaitlyn, Sbrollini, Rahul, Sharma, Peter A D, Steel, Michele, Steinkamp, Roniel, Weinberg, David Stephenson, Wellman, Antoun, Nader, Paul, Fitzgerald, Michaela, Ritz, Greg, Bryson, Alexandra, Craig, Cassandra, Farhat, Braden, Gammon, Wade, Gofton, Nicole, Harris, Karl, Lalonde, Allan, Liew, Bradley, Meulenkamp, Kendra, Sonnenburg, Eugene, Wai, Geoffrey, Wilkin, Karen, Troxell, Mary Ellen, Alderfer, Jason, Brannen, Christopher, Cupitt, Stacy, Gerhart, Renee, McLin, Julie, Sheidy, Katherine, Yurick, Fei, Chen, Karen, Dragert, Geza, Kiss, Halina, Malveaux, Deborah, McCloskey, Scott, Mellender, Sagar S, Mungekar, Helaine, Noveck, Carlos, Sagebien, Luat, Biby, Gail, McKelvy, Anna, Richards, Ramon, Abola, Brittney, Ayala, Darcy, Halper, Ana, Mavarez, Sabeen, Rizwan, Stephen, Choi, Imad, Awad, Brendan, Flynn, Patrick, Henry, Richard, Jenkinson, Lilia, Kaustov, Elizabeth, Lappin, Paul, McHardy, Amara, Singh, Joanne, Donnelly, Meera, Gonzalez, Christopher, Haydel, Jon, Livelsberger, Theresa, Pazionis, Bridget, Slattery, Maritza, Vazquez-Trejo, Jaime, Baratta, Michael, Cirullo, Brittany, Deiling, Laura, Deschamps, Michael, Glick, Daniel, Katz, James, Krieg, Jennifer, Lessin, Jeffrey, Mojica, Marc, Torjman, Rongyu, Jin, Mary Jane, Salpeter, Mark, Powell, Jeffrey, Simmons, Prentiss, Lawson, Promil, Kukreja, Shanna, Graves, Adam, Sturdivant, Ayesha, Bryant, Sandra Joyce, Crump, Michelle, Verrier, James, Green, Matthew, Menon, Richard, Applegate, Ana, Arias, Natasha, Pineiro, Jeffrey, Uppington, Phillip, Wolinsky, Amy, Gunnett, Jennifer, Hagen, Sara, Harris, Kevin, Hollen, Brian, Holloway, Mary Beth, Horodyski, Trevor, Pogue, Ramachandran, Ramani, Cameron, Smith, Anna, Woods, Matthew, Warrick, Kelly, Flynn, Paul, Mongan, Yatish, Ranganath, Sean, Fernholz, Esperanza, Ingersoll-Weng, Anil, Marian, Melinda, Seering, Zita, Sibenaller, Lori, Stout, Allison, Wagner, Alicia, Walter, Cynthia, Wong, Denise, Orwig, Maithri, Goud, Chris, Helker, Lydia, Mezenghie, Brittany, Montgomery, Peter, Preston, J Sanford, Schwartz, Ramona, Weber, Lee A, Fleisher, Samir, Mehta, Alisa J, Stephens-Shields, Cassandra, Dinh, Jacques E, Chelly, Shiv, Goel, Wende, Goncz, Touichi, Kawabe, Sharad, Khetarpal, Amy, Monroe, Vladislav, Shick, Max, Breidenstein, Timothy, Dominick, Alexander, Friend, Donald, Mathews, Richard, Lennertz, Robert, Sanders, Helen, Akere, Tyler, Balweg, Amber, Bo, Christopher, Doro, David, Goodspeed, Gerald, Lang, Maggie, Parker, Amy, Rettammel, Mary, Roth, Marissa, White, Paul, Whiting, Brian F S, Allen, Tracie, Baker, Debra, Craven, Matt, McEvoy, Teresa, Turnbo, Stephen, Kates, Melanie, Morgan, Teresa, Willoughby, Wade, Weigel, David, Auyong, Ellie, Fox, Tina, Welsh, Bruce, Cusson, Sean, Dobson, Christopher, Edwards, Lynette, Harris, Daryl, Henshaw, Kathleen, Johnson, Glen, McKinney, Scott, Miller, Jon, Reynolds, B Scott, Segal, Jimmy, Turner, David, VanEenenaam, Robert, Weller, Jineli, Lei, Miriam, Treggiari, Shamsuddin, Akhtar, Marcelle, Blessing, Chanel, Johnson, Michael, Kampp, Kimberly, Kunze, Mary, O'Connor, Jinlei, Li, Duminda N, Wijeysundera, Sachin, Kheterpal, Reneé H, Moore, Alexander K, Smith, Laura L, Tosi, Lee, Fleisher, Christine, Langlois, Samuel, Oduwole, and Thomas, Rose

Subjects
Male, Analgesics, Canada, Pain, Postoperative, Hip Fractures, Pain, General Medicine, Anesthesia, General, Anesthesia, Spinal, Patient Satisfaction, Internal Medicine, Humans, Female, Aged
Abstract

The REGAIN (Regional versus General Anesthesia for Promoting Independence after Hip Fracture) trial found similar ambulation and survival at 60 days with spinal versus general anesthesia for hip fracture surgery. Trial outcomes evaluating pain, prescription analgesic use, and patient satisfaction have not yet been reported.To compare pain, analgesic use, and satisfaction after hip fracture surgery with spinal versus general anesthesia.Preplanned secondary analysis of a pragmatic randomized trial. (ClinicalTrials.gov: NCT02507505).46 U.S. and Canadian hospitals.Patients aged 50 years or older undergoing hip fracture surgery.Spinal or general anesthesia.Pain on postoperative days 1 through 3; 60-, 180-, and 365-day pain and prescription analgesic use; and satisfaction with care.A total of 1600 patients were enrolled. The average age was 78 years, and 77% were women. A total of 73.5% (1050 of 1428) of patients reported severe pain during the first 24 hours after surgery. Worst pain over the first 24 hours after surgery was greater with spinal anesthesia (rated from 0 [no pain] to 10 [worst pain imaginable]; mean difference, 0.40 [95% CI, 0.12 to 0.68]). Pain did not differ across groups at other time points. Prescription analgesic use at 60 days occurred in 25% (141 of 563) and 18.8% (108 of 574) of patients assigned to spinal and general anesthesia, respectively (relative risk, 1.33 [CI, 1.06 to 1.65]). Satisfaction was similar across groups.Missing outcome data and multiple outcomes assessed.Severe pain is common after hip fracture. Spinal anesthesia was associated with more pain in the first 24 hours after surgery and more prescription analgesic use at 60 days compared with general anesthesia.Patient-Centered Outcomes Research Institute

Published
2022

3. Noninvasive Assessment of Right Ventricle Function and Pulmonary Artery Pressure Using Transthoracic Echocardiography in Women With Pre-Eclampsia: An Exploratory Study

Author

Akila Subramaniam, Tekuila Carter, Michael Froelich, Jacob Meers, Ryan Densmore, Tamas Jilling, Ahmed Zaky, Alan T.N. Tita, Sadis Matalon, and Adam Sturdivant

Subjects
medicine.medical_specialty, Cardiac output, pre-eclampsia, Cardiology, Early detection, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Anesthesiology, Internal medicine, medicine.artery, Medicine, echo cardiogram, Subclinical infection, Eclampsia, business.industry, General Engineering, medicine.disease, Pulmonary hypertension, medicine.anatomical_structure, Ventricle, Pulmonary artery, multifactorial pulmonary hypertension, Vascular resistance, Gestation, Obstetrics/Gynecology, business, 030217 neurology & neurosurgery
Abstract

Background and objective Pre-eclampsia (PEC) is associated with the release of anti-angiogenic factors that are incriminated in raising systemic and pulmonary vascular resistance (PVR). Compared to the left heart and systemic circulation, much less attention has been paid to the right heart and pulmonary circulation in patients with PEC. We used transthoracic echocardiography (TTE) to estimate pulmonary artery (PA) pressure and right ventricular (RV) function in women with PEC. Materials and methods We conducted a case-control study at a tertiary care academic center. Ten early PEC (

Published
2021

4. Engaging patients as partners in a multicentre trial of spinal versus general anaesthesia for older adults

Author

Jennifer Hruslinski, Diane A. Menio, Robert A. Hymes, J. Douglas Jaffe, Christine Langlois, Lolita Ramsey, Lakisha J. Gaskins, Mark D. Neuman, Thomas Looke, Sandra Bent, Ariana Franco-Mora, Pamela Hedrick, Matthew Newbern, Rafik Tadros, Karen Pealer, Edward Marcantonio, Kamen Vlassakov, Carolyn Buckley, Svetlana Gorbatov, James Gosnell, Talora Steen, Avery Vafai, Jose Zeballos, Louis Cardenas, Ashley Berry, John Getchell, Nicholas Quercetti, Daniel I. Sessler, Sabry Ayad, Manal Hassan, Assad Ali, Gauasan Bajracharya, Damien Billow, Michael Bloomfield, Kavita Elliott, Robert Hampton, Linda He, Hooman Honar, Dilara Khoshknabi, Daniel Kim, Paul Minko, Adam Morris, Azfar Niazi, Tara Nutcharoen, Jeffrey Roberts, Partha Saha, Ahmed Salih, Alexis Skolaris, Taylor Stang, Victor Strimbu, Jesse Templeton, Andrew Volio, Jiayi Wang, Kelly Bolkus, Matthew DeAngelis, Gregory Dodson, Jeffrey Gerritsen, Brian McEniry, Ludmil Mitrev, Kwesi Kwofie, Flynn Bonazza, Vera Lloyd, Izabela Panek, Jared Dabiri, Chris Chavez, Jason Craig, Todd Davidson, Chad Dietrichs, Cheryl Fleetwood, Mike Foley, Chris Getto, Susie Hailes, Sarah Hermes, Andy Hooper, Greg Koener, Kate Kohls, Leslie Law, Adam Lipp, Allison Losey, William Nelson, Mario Nieto, Pam Rogers, Steve Rutman, Garrett Scales, Barbara Sebastian, Tom Stanciu, Gregg Lobel, Michelle Giampiccolo, Dara Herman, Margit Kaufman, Bryan Murphy, Clara Pau, Thomas Puzio, Marlene Veselsky, Trevor Stone, Kelly Apostle, Dory Boyer, Brenda Chen Fan, Susan Lee, Mike Lemke, Richard Merchant, Farhad Moola, Kyrsten Payne, Bertrand Perey, Darius Viskontas, Mark Poler, Patricia D'Antonio, Richard Sheppard, Amer Abdullah, Jamie Fish-Fuhrmann, Mark Giska, Christina Fidkowski, Trent Guthrie, William Hakeos, Lillian Hayes, Joseph Hoegler, Katherine Nowak, Robert Hymes, Jeffery Beck, Jaslynn Cuff, Greg Gaski, Sharon Haaser, Michael Holzman, A. Stephen Malekzadeh, Jeff Schulman, Cary Schwartzbach, Frederick Sieber, Tangwan Azefor, Charles Brown, Arman Davani, Mahmood Jaberi, Courtney Masear, Balram Sharma, Syed Basit Haider, Carolyn Chungu, Ali Ebrahimi, Karim Fikry, Kerri Gannon, Andrew Marcantonio, Meredith Pace, David Sanders, Collin Clarke, Abdel Lawendy, Gary Schwartz, Mohit Garg, Joseph Kim, Mitchell Marshall, Juan Caurci, Ekow Commeh, Randy Cuevas, Germaine Cuff, Lola Franco, David Furguiele, Matthew Giuca, Melissa Allman, Omid Barzideh, James Cossaro, Armando D'Arduini, Anita Farhi, Jason Gould, John Kafel, Anuj Patel, Abraham Peller, Hadas Reshef, Mohammed Safur, Fiore Toscano, Tiffany Tedore, Michael Akerman, Eric Brumberger, Sunday Clark, Rachel Friedlander, Anita Jegarl, Joseph Lane, John P. Lyden, Nili Mehta, Matthew T. Murrell, Nathan Painter, William Ricci, Kaitlyn Sbrollini, Rahul Sharma, Peter A.D. Steel, Michele Steinkamp, Roniel Weinberg, David Stephenson Wellman, Antoun Nader, Paul Fitzgerald, Michaela Ritz, Steven Papp, Greg Bryson, Alexandra Craig, Cassandra Farhat, Braden Gammon, Wade Gofton, Nicole Harris, Karl Lalonde, Allan Liew, Bradley Meulenkamp, Kendra Sonnenburg, Eugene Wai, Geoffrey Wilkin, Derek Donegan, Cassandra Dinh, Nabil Elkassabany, Annamarie Horan, Samir Mehta, Karen Troxell, Mary Ellen Alderfer, Jason Brannen, Christopher Cupitt, Stacy Gerhart, Renee McLin, Julie Sheidy, Katherine Yurick, Jeffrey Carson, Fei Chen, Karen Dragert, Geza Kiss, Halina Malveaux, Deborah McCloskey, Scott Mellender, Sagar S. Mungekar, Helaine Noveck, Carlos Sagebien, Barry Perlman, Luat Biby, Gail McKelvy, Anna Richards, Syed Azim, Ramon Abola, Brittney Ayala, Darcy Halper, Ana Mavarez, Stephen Choi, Imad Awad, Brendan Flynn, Patrick Henry, Richard Jenkinson, Lilia Kaustov, Elizabeth Lappin, Paul McHardy, Amara Singh, Ellen Hauck, Joanne Donnelly, Meera Gonzalez, Christopher Haydel, Jon Livelsberger, Theresa Pazionis, Bridget Slattery, Maritza Vazquez-Trejo, Eric Schwenk, Jaime Baratta, Brittany Deiling, Laura Deschamps, Michael Glick, Daniel Katz, James Krieg, Jennifer Lessin, Marc Torjman, Ki Jinn Chin, Rongyu Jin, Mary Jane Salpeter, Mark Powell, Jeffrey Simmons, Prentiss Lawson, Promil Kukreja, Shanna Graves, Adam Sturdivant, Ayesha Bryant, Sandra Joyce Crump, Derek Dillane, Michael Taylor, Michelle Verrier, Richard Applegate, Ana Arias, Natasha Pineiro, Jeffrey Uppington, Phillip Wolinsky, Joshua Sappenfield, Amy Gunnett, Jennifer Hagen, Sara Harris, Kevin Hollen, Brian Holloway, Mary Beth Horodyski, Trevor Pogue, Ramachandran Ramani, Cameron Smith, Anna Woods, Matthew Warrick, Kelly Flynn, Paul Mongan, Yatish Ranganath, Sean Fernholz, Esperanza Ingersoll-Weng, Anil Marian, Melinda Seering, Zita Sibenaller, Lori Stout, Allison Wagner, Alicia Walter, Cynthia Wong, Jay Magaziner, Denise Orwig, Trina Brown, Jim Dattilo, Susan Ellenberg, Rui Feng, Lee Fleisher, Lakisha Gaskins, Maithri Goud, Chris Helker, Lydia Mezenghie, Brittany Montgomery, Peter Preston, Alisa Stephens, J. Sanford Schwartz, Ann Tierney, Ramona Weber, Jacques Chelly, Shiv Goel, Wende Goncz, Touichi Kawabe, Sharad Khetarpal, Kevin King, Frank Kunkel, Charles Luke, Amy Monroe, Vladislav Shick, Anthony Silipo, Caroline Stehle, Katherine Szabo, Sudhakar Yennam, Mark Hoeft, Max Breidenstein, Timothy Dominick, Alexander Friend, Donald Mathews, Richard Lennertz, Helen Akere, Tyler Balweg, Amber Bo, Christopher Doro, David Goodspeed, Gerald Lang, Maggie Parker, Amy Rettammel, Mary Roth, Robert Sanders, Marissa White, Paul Whiting, Brian Allen, Tracie Baker, Debra Craven, Matt McEvoy, Teresa Turnbo, Stephen Kates, Melanie Morgan, Teresa Willoughby, Wade Weigel, David Auyong, Ellie Fox, Tina Welsh, Bruce Cusson, Sean Dobson, Christopher Edwards, Lynette Harris, Daryl Henshaw, Kathleen Johnson, Glen McKinney, Scott Miller, Jon Reynolds, Jimmy Turner, David VanEenenaam, Robert Weller, Shamsuddin Akhtar, Marcelle Blessing, Chanel Johnson, Michael Kampp, Kimberly Kunze, Jinlei Li, Mary O'Connor, and Miriam Treggiari

Subjects
medicine.medical_specialty, Canada, Research Subjects, Patient engagement, Hip fracture surgery, Patient Advocacy, Anesthesia, General, Patient advocacy, Anesthesia, Spinal, 03 medical and health sciences, 0302 clinical medicine, Nursing, 030202 anesthesiology, Fracture Fixation, Medicine, Humans, General anaesthesia, Cooperative Behavior, Geriatrics, Hip fracture, business.industry, Hip Fractures, Lived experience, Age Factors, Research process, medicine.disease, United States, Anesthesiology and Pain Medicine, Research Design, Patient Participation, business, Decision Making, Shared
Abstract

Summary Engaging patients—defined broadly as individuals with lived experience of a given condition, family members, caregivers, and the organisations that represent them—as partners in research is a priority for policymakers, funders, and the public. Nonetheless, formal efforts to engage patients are absent from most studies, and models to support meaningful patient engagement in clinical anaesthesia research have not been previously described. Here, we review our experience in developing and implementing a multifaceted patient engagement strategy within the Regional Versus General Anesthesia for Promoting Independence After Hip Fracture (REGAIN) surgery trial, an ongoing randomised trial comparing spinal vs general anaesthesia for hip fracture surgery in 1600 older adults across 45 hospitals in the USA and Canada. This strategy engaged patients and their representatives at both the level of overall trial oversight and at the level of individual recruiting sites. Activities spanned a continuum ranging from events designed to elicit patients' input on key decisions to longitudinal collaborations that empowered patients to actively participate in decision-making related to trial design and management. Engagement activities were highly acceptable to participants and led to concrete changes in the design and conduct of the REGAIN trial. The REGAIN experience offers a model for future efforts to engage patients as partners in clinical anaesthesia research, and highlights potential opportunities for investigators to increase the relevance of anaesthesia studies by incorporating patient voices and perspectives into the research process.

Published
2020

5. Effects of Music Therapy During Total Knee Arthroplasty Under Spinal Anesthesia: A Prospective Randomized Controlled Study

Author

Adam Sturdivant, Alexander Woods, Hari Kalagara, Lisa MacBeth, Promil Kukreja, William A Potter, Katherine Talbott, and Elie Ghanem

Subjects
medicine.medical_specialty, Music therapy, patient satisfaction, Sedation, music therapy, 030204 cardiovascular system & hematology, behavioral disciplines and activities, law.invention, 03 medical and health sciences, 0302 clinical medicine, Patient satisfaction, perioperative anxiety, Randomized controlled trial, law, Anesthesiology, Medicine, Psychology, spinal anesthesia, business.industry, General Engineering, Perioperative, humanities, Clinical trial, Physical therapy, Anxiety, medicine.symptom, business, Propofol, human activities, 030217 neurology & neurosurgery, Osteopathic Medicine, medicine.drug
Abstract

Purpose Music therapy is an effective non-pharmacologic intervention that is cost-effective, easy to implement, and customize. It has been shown to significantly alleviate anxiety and improve patient satisfaction. In this study, we aimed to compare music therapy to a control (no music) group with respect to sedation requirements, anxiety levels, and patient satisfaction for patients undergoing total knee arthroplasty under spinal anesthesia. Methods In this randomized controlled study, we compared the effect of music therapy in patients ≥ 18 years old. Patients undergoing total knee arthroplasty were screened for the study to rule out any contraindications for spinal anesthesia. Patients were randomized in a 1:1 ratio for either the "music" or "control" group. Both groups were compared for sedation requirements, preoperative and postoperative anxiety levels, and patient satisfaction. Results Subjects in the music group had a statistically significant lower than average State-Trait Anxiety Inventory (STAI)-State baseline score as compared to the control group (music group 31.00 (standard deviation (SD) 1.44), control group 38.04 (SD 2.35); p = 0.01). Postoperative STAI-State-Trait Anxiety Inventory (STAI)-State scores for the music group were lower for the music group than the control group (music group 28.34 (SD 1.64), control group 32.21 (SD 1.56), p= 0.09). STAI-Trait scores were similar pre-operatively, but significantly less post-operatively in the music group (28.14 SD 1.0) as compared to the control group (34.71 SD 2.31); p = 0.01. Propofol dose per kilogram per surgical minute was similar between the two groups (music group 0.05, control group 0.06; p= 0.264). Patient satisfaction scores with their perioperative experience were higher in the music group (p= 0.009). Conclusions Music therapy may be offered as an alternative to traditional anxiolytics intra-operatively. However further studies are warranted to evaluate whether or not music therapy can decrease sedation and anxiolytic medications during surgery. The type and mode of delivery of music also need to be studied to better understand the impact of music therapy. Clinical trial registry: Clinicaltrials.gov # NCT03569397.

Published
2020

6. The bio-sonographic index. A novel modality for early detection of acute kidney injury after complex vascular surgery. A protocol for an exploratory prospective study

Author

Amandiy Liwo, Ashita Tolwani, Adam Sturdivant, Jean-Francois Pittet, Dan E. Berkowitz, Brad Meers, Sejong Bae, Nicole McAnally, Novak Zdenek, Adam W. Beck, Ahmed Zaky, Michelle L. Robbin, and Shama Ahmad

Subjects
Cardiovascular Procedures, Vascular Surgery, 030204 cardiovascular system & hematology, Biochemistry, Vascular Medicine, Stiffness, chemistry.chemical_compound, 0302 clinical medicine, Medicine and Health Sciences, Medicine, Prospective Studies, Prospective cohort study, education.field_of_study, Multidisciplinary, Endovascular Procedures, Acute kidney injury, Acute Kidney Injury, Urinary Biomarkers, Insulin-Like Growth Factor Binding Proteins, Physical Sciences, Elasticity Imaging Techniques, Anatomy, Aneurysms, medicine.medical_specialty, Urinary system, Science, Population, Materials Science, Material Properties, Surgical and Invasive Medical Procedures, 03 medical and health sciences, Lipocalin-2, Internal medicine, Registered Report Protocol, Mechanical Properties, Humans, Vascular Diseases, education, Creatinine, Tissue Inhibitor of Metalloproteinase-2, business.industry, Biology and Life Sciences, 030208 emergency & critical care medicine, Kidneys, Renal System, Cell Cycle Checkpoints, Vascular surgery, medicine.disease, chemistry, Surgical Repair, business, Complication, Biomarkers, Kidney disease
Abstract

ObjectiveAcute kidney injury (AKI) is a common complication of complex aortic surgery with high mortality, morbidity and health care expense. The current definition of AKI does not allow for structural characterization of the kidneys and utilizes functional indices with substantial limitations leading to delayed diagnosis and ineffective interventions. The aim of this study is to develop a method of early detection of structural renal abnormalities that can precede and predict the occurrence of AKI in this population. We propose a novel combined index of ultrasonography (shear wave elastography), biomarkers of renal stress (urinary insulin growth factor binding protein-7, IGFBP-7 and inhibitor of tissue metalloproteinase-2, TIMP-2) and renal injury markers (urinary neutrophil gelatinase-associated lipocalin -NGAL)- the bio-sonographic index (BSI).MethodsA prospective observational study at a tertiary referral center will be performed enrolling 80 patients undergoing elective open and endovascular repair of the visceral aorta. The BSI will be evaluated at baseline, and at 6 and 24 hours after the procedure. The primary outcome is the occurrence of AKI according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria. Each patient will be his/her own control. A reference group of 15 healthy volunteers who are not undergoing interventions will be enrolled to test the feasibility of and to refine the novel SWE protocol. The BSI will be tested for its predictability of the occurrence of AKI. Comparisons will be made between individual and combined components of the BSI and traditional markers used in the KDIGO definition; serum creatinine and urine output in terms of baseline status of the kidney. Correlations will be made between the BSI and conventional indices of AKI and exploratory analyses will be conducted to identify individual disease patterns using the BSI.DiscussionWe hypothesize that the BSI will be a sensitive index of early structural abnormalities that precede and predict the occurrence of AKI as defined by KDIGO in complex vascular surgery.Trial registrationClinicalTrials.govNCT04144894. Registered 1/6/2020.

Published
2020

7. Anterior quadratus lumborum block analgesia for total hip arthroplasty: a randomized, controlled study

Author

Hari Kalagara, Vincent W. S. Chan, Lisa MacBeth, Promil Kukreja, Charity J. Morgan, Elie Ghanem, and Adam Sturdivant

Subjects
business.industry, Sedation, Analgesic, Block (permutation group theory), General Medicine, law.invention, 03 medical and health sciences, 0302 clinical medicine, Anesthesiology and Pain Medicine, Patient satisfaction, Randomized controlled trial, Opioid, 030202 anesthesiology, law, Anesthesia, Medicine, In patient, medicine.symptom, business, 030217 neurology & neurosurgery, Total hip arthroplasty, medicine.drug
Abstract

Background and objectivesQuadratus lumborum (QL) block is a new regional analgesic technique for upper and lower abdominal surgeries as part of a multimodal analgesic regime. It has also been reported to relieve pain after total hip arthroplasty (THA). In this prospective, randomized, double-blind study, we compared QL block with control (no block) in patients undergoing primary THA.MethodsEighty patients undergoing primary THA surgery under spinal anesthesia were randomized into two groups, one with and one without QL block. The patients in both groups were randomized after sedation, positioning and ultrasound scanning. Both the patient and the researcher collecting data were blinded to the patient’s group assignment. Opioid consumption and visual analog scores (VAS) pain scores were measured at 12, 24, and 48 hours after surgery. Also, the ambulation distance, patient satisfaction, and length of stay were recorded.ResultsThe study analysis included 36 patients in the QL group and 35 patients in the control group. Both VAS pain score at 24 hours (difference −1.76, 95% CI −2.87 to −0.64) and cumulative opioid consumption were significantly lower in the QL group at 12, 12–24, 24, 24–48, and 48 hours after surgery as compared with the control group (difference at 48 hours −36.13, 95% CI −62.89 to −9.37) (pConclusionsOur preliminary data show that the QL block provided effective analgesia and decreased opioid requirements up to 48 hours after primary THA.Trial registration numberNCT03408483

Published
2019

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