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4. Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): study protocol for a randomized controlled trial

Author

Cavalcanti, AB, Berwanger, O, Suzumura, ÉA, Amato, MB, Tallo, FS, Rezende, AC, Telles, MM, Romano, E, Guimarães, HP, Regenga, MM, Takahashi, LN, Oliveira, RP, Carvalho, VO, Díaz Quijano, FA, Carvalho, CR, Kodama, AA, Ribeiro, GF, Abreu, MO, Oliveira, IM, Guyatt, G, Ferguson, N, Walter, S, Vasconcelos, MO, Segundo, VJ, Ferraz, ÍL, Silva, RS, de Oliveira Filho, W, Silva, NB, Heirel, C, Takatani, RR, Neto, JA, Neto, JC, Almeida, SD, Chamy, G, Neto, GJ, Dias, AP, Silva, RR, Tavares, RC, Souza, ML, Decio, JC, Lima, CM, Neto, FF, Oliveira, KR, Dias, PP, Brandão, AL, Ramos, JE Jr, Vasconcelos, PT, Flôres, DG, Filho, GR, Andrade, IG, Martinez, A, França, GG, Monteiro, LL, Correia, EI, Ribeiro, W, Pereira, AJ, Andrade, W, Leite, PA, Feto, JE, Holanda, MA, Amorim, FF, Margalho, SB, Domingues, SM Jr, Ferreira, CS, Ferreira, CM, Rabelo, LA, Duarte, JN, Lima, FB, Kawaguchi, IA, Maia, MO, Correa, FG, Ribeiro, RA, Caser, E, Moreira, CL, Marcilino, A, Falcão, JG, Jesus, KR, Tcherniakovisk, L, Dutra, VG, Thompson, MM, Piras, C, Giuberti, J. Jr, Silva, AS, Santos, JR, Potratz, JL, Paula, LN, Bozi, GG, Gomes, BC, Vassallo, PF, Rocha, E, Lima, MH, Ferreira, A. F, Gonçalves, F, Pereira, SA, Nobrega, MS, Caixeta, CR, Moraes, AP, Carvalho, AG, Alves, JD, Carvalho, FB, Moreira, FB, Starling, CM, Couto, WA, Bitencourt, WS, Silva, SG, Felizardo, LR, Nascimento, FJ, Santos, D, Zanta, CC, Martins, MF, Naves, SA, Silva, FD, Laube, G. Jr, Galvão, EL, Sousa, MF, Souza, MM, Carvalho, FL, Bergo, RR, Rezende, CM, Tamazato, EY, Sarat, SC Jr, Almeida, PS, Gorski, AG, Matsui, M, Neto, EE, Nomoto, SH, Lima, ZB, Inagaki, AS, Gil, FS, Araújo, MF, Oliveira, AE, Correa, TA, Mendonça, A, Reis, H, Carneiro, SR, Rego, LR, Cunha, AF, Barra, WF, Carneiro, M, Batista, RA, Zoghbi, KK, Machado, NJ, Ferreira, R, Apoena, P, Leão, RM, Martins, ER, Oliveira, ME, Odir, I, Kleber, W, Tavares, D, Araújo, ME, Brilhante, YN, Tavares, DC, Carvalho, WL, Winveler, GF, Filho, AC, Cavalcanti, RA, Grion, CM, Reis, AT, Festti, J, Gimenez, FM, Larangeira, AS, Cardoso, LT, Mezzaroba, TS, Kauss, IA, Duarte, PA, Tozo, TC, Peliser, P, Germano, A, Gurgel, SJ, Silva, SR, Kuroda, CM, Herek, A, Yamada, SS, Schiavetto, PM, Wysocki, N, Matsubara, RR, Sales, JA Jr, Laprovita, MP, Pena, FM, Sá, A, Vianna, A, Verdeal, JC, Martins, GA, Salgado, DR, Coelho, AM, Coelho, M, Morong, AS, Poquiriqui, RM, Ferreira, AP, Lucena, DN, Marino, NF, Moreira, MA, Uratani, CC, Severino, MA, Silva, PN, Medeiros, LG, Filho, FG, Guimarães, DM, Rezende, VM, Carbonell, RC, Trindade, RS, Pellegrini, JA, Boniatti, MM, Santos, MC, Boldo, R, Oliveira, VM, Corrêa, VM, Nedel, W, Teixeira, C, Schaich, F, Tagliari, L, Savi, A, Schulz, LF, Maccari, JG, Seeger, GM, Foernges, RB, Rieder, MM, Becker, DA, Broilo, FP, Schwarz, P, Alencastro, A, Berto, P, Backes, F, Dias, FS, Blattner, C, Martins, ET, Scaglia, NC, Vieira, SR, Prado, KF, Fialkow, L, Franke, C, Vieira, DF, Moraes, RB, Marques, LS, Hopf, JL, Wawrzeniak, IC, Rech, TH, Albuquerque, RB, Guerreiro, MO, Teixeira, LO, Macedo, PL, Bainy, MP, Ferreira, EV, Martins, MA, Andrade, LA, Machado, FO, Burigo, AC, Pincelli, M, Kretzer, L, Maia, IS, Cordeiro, RB, Westphal, G, Cramer, AS, Dadam, MM, Barbosa, PO, Caldeira, M, Brilenger, CO, Horner, MB, Oliveira, GL, Germiniani, BC, Duarte, R, Assef, MG, Rosso, D, Bigolin, R, Vanzuita, R, Prado, LF, Oliveira, V, Reis, DL, Morais, MO, Bastos, RS, Santana, HS, Silva, AO, Cacau, LA, Almeida, MS, Canavessi, HS, Nogueira, EE, Pavia, CL, Araujo, JF, Lira, JA, Nienstedt, EC, Smith, TC, Romano, M, Barros D, Costa, AF, Takahashi, L, Werneck, V, Farran, J, Henriques, LA, Miura, C, Lopes, RD, Vendrame, LS, Sandri, P, Galassi, MS, Amato, P, Toufen, C. Jr, Santiago, RR, Hirota, AS, Park, M, Azevedo, LC, Malbouison, LM, Costa, MC, Taniguchi, L, Pompílio, CE, Baruzzi, C, Andrade, AH, Taira, EE, Taino, B, Oliveira, CS, Silva, AC, Ísola, A, Rezende, E, Rodrigues, RG, Rangel, VP, Luzzi, S, Giacomassi, IW, Nassar, AP Jr, Souza, AR, Rahal, L, Nunes, AL, Giannini, F, Menescal, B, Morais, JE, Toledo, D, Morsch, RD, Merluzzi, T, Amorim, DS, Bastos, AC, Santos, PL, Silva, SF, Gallego, RC, Santos, GD, Tucci, M, Costa, RT, Santos, LS, Demarzo, SE, Schettino, GP, Suzuki, VC, Patrocinio, AC, Martins, ML, Passos, DB, Cappi, SB, Gonçalves, I. Jr, Borges, MC, Lovato, W, Tavares, MV, Morales, D, Machado, LA, Torres, FC, Gomes, TM, Cerantola, RB, Góis, A, Marraccini, T, Margarida, K, Cavalcante, E, Machado, FR, Mazza, BF, Santana, HB, Mendez, VM, Xavier, PA, Rabelo, MV, Schievano, FR, Pinto, WA, Francisco, RS, Ferreira, EM, Silva, DC, Arduini, RG, Aldrighi, JR, Amaro, AF, Conde, KA, Pereira, CA, Tarkieltaub, E, Oliver, WR, Guadalupe, EG, Acerbi, PS, Tomizuka, CI, Oliveira, TA, Geha, NN, Mecatti, GC, Piovesan, MZ, Salomão, MC, Moreno, MS, Orsatti, VN, Miranda, W, Ray, A, Guerra, A, Filho, ML, Ferreira, FH Jr, Filho, EV, Canzi, RA, Giuberti, AF, Garcez, MC, Sala, AD, Suguitani, EO, Kazue, P, Oliveira, LR, Infantini, RM, Carvalho, FR, Andrade, LC, Santos, TM, Carmona, CV, Figueiredo, LC, Falcão, A, Dragosavak, D, Filho, WN, Lunardi, MC, Lago, R, Gatti, C, Chiasso, TM, Santos, GO, Araujo, AC, Ornellas, IB, Vieira, VM, Hajjar, LA, Figueiredo, AC, Damasceno, B, Hinestrosa, A, Diaz Quijano, FA, CORTEGIANI, Andrea, RAINERI, Santi Maurizio, Cavalcanti, AB, Berwanger, O, Suzumura, ÉA, Amato, MB, Tallo, FS, Rezende, AC, Telles, MM, Romano, E, Guimarães, HP, Regenga, MM, Takahashi, LN, Oliveira, RP, Carvalho, VO, Díaz-Quijano, FA, Carvalho, CR, Kodama, AA, Ribeiro, GF, Abreu, MO, Oliveira, IM, Guyatt, G, Ferguson, N, Walter, S, Vasconcelos, MO, Segundo, VJ, Ferraz, ÍL, Silva, RS, de Oliveira Filho, W, Silva, NB, Heirel, C, Takatani, RR, Neto, JA, Neto, JC, Almeida, SD, Chamy, G, Neto, GJ, Dias, AP, Silva, RR, Tavares, RC, Souza, ML, Decio, JC, Lima, CM, Neto, FF, Oliveira, KR, Dias, PP, Brandão, AL, Ramos, JE Jr, Vasconcelos, PT, Flôres, DG, Filho, GR, Andrade, IG, Martinez, A, França, GG, Monteiro, LL, Correia, EI, Ribeiro, W, Pereira, AJ, Andrade, W, Leite, PA, Feto, JE, Holanda, MA, Amorim, FF, Margalho, SB, Domingues, SM Jr, Ferreira, CS, Ferreira, CM, Rabelo, LA, Duarte, JN, Lima, FB, Kawaguchi, IA, Maia, MO, Correa, FG, Ribeiro, RA, Caser, E, Moreira, CL, Marcilino, A, Falcão, JG, Jesus, KR, Tcherniakovisk, L, Dutra, VG, Thompson, MM, Piras, C, Giuberti, J Jr, Silva, AS, Santos, JR, Potratz, JL, Paula, LN, Bozi, GG, Gomes, BC, Vassallo, PF, Rocha, E, Lima, MH, Ferreira, A F, Gonçalves, F, Pereira, SA, Nobrega, MS, Caixeta, CR, Moraes, AP, Carvalho, AG, Alves, JD, Carvalho, FB, Moreira, FB, Starling, CM, Couto, WA, Bitencourt, WS, Silva, SG, Felizardo, LR, Nascimento, FJ, Santos, D, Zanta, CC, Martins, MF, Naves, SA, Silva, FD, Laube, G Jr, Galvão, EL, Sousa, MF, Souza, MM, Carvalho, FL, Bergo, RR, Rezende, CM, Tamazato, EY, Sarat, SC Jr, Almeida, PS, Gorski, AG, Matsui, M, Neto, EE, Nomoto, SH, Lima, ZB, Inagaki, AS, Gil, FS, Araújo, MF, Oliveira, AE, Correa, TA, Mendonça, A, Reis, H, Carneiro, SR, Rego, LR, Cunha, AF, Barra, WF, Carneiro, M, Batista, RA, Zoghbi, KK, Machado, NJ, Ferreira, R, Apoena, P, Leão, RM, Martins, ER, Oliveira, ME, Odir, I, Kleber, W, Tavares, D, Araújo, ME, Brilhante, YN, Tavares, DC, Carvalho, WL, Winveler, GF, Filho, AC, Cavalcanti, RA, Grion, CM, Reis, AT, Festti, J, Gimenez, FM, Larangeira, AS, Cardoso, LT, Mezzaroba, TS, Kauss, IA, Duarte, PA, Tozo, TC, Peliser, P, Germano, A, Gurgel, SJ, Silva, SR, Kuroda, CM, Herek, A, Yamada, SS, Schiavetto, PM, Wysocki, N, Matsubara, RR, Sales, JA Jr, Laprovita, MP, Pena, FM, Sá, A, Vianna, A, Verdeal, JC, Martins, GA, Salgado, DR, Coelho, AM, Coelho, M, Morong, AS, Poquiriqui, RM, Ferreira, AP, Lucena, DN, Marino, NF, Moreira, MA, Uratani, CC, Severino, MA, Silva, PN, Medeiros, LG, Filho, FG, Guimarães, DM, Rezende, VM, Carbonell, RC, Trindade, RS, Pellegrini, JA, Boniatti, MM, Santos, MC, Boldo, R, Oliveira, VM, Corrêa, VM, Nedel, W, Teixeira, C, Schaich, F, Tagliari, L, Savi, A, Schulz, LF, Maccari, JG, Seeger, GM, Foernges, RB, Rieder, MM, Becker, DA, Broilo, FP, Schwarz, P, Alencastro, A, Berto, P, Backes, F, Dias, FS, Blattner, C, Martins, ET, Scaglia, NC, Vieira, SR, Prado, KF, Fialkow, L, Franke, C, Vieira, DF, Moraes, RB, Marques, LS, Hopf, JL, Wawrzeniak, IC, Rech, TH, Albuquerque, RB, Guerreiro, MO, Teixeira, LO, Macedo, PL, Bainy, MP, Ferreira, EV, Martins, MA, Andrade, LA, Machado, FO, Burigo, AC, Pincelli, M, Kretzer, L, Maia, IS, Cordeiro, RB, Westphal, G, Cramer, AS, Dadam, MM, Barbosa, PO, Caldeira, M, Brilenger, CO, Horner, MB, Oliveira, GL, Germiniani, BC, Duarte, R, Assef, MG, Rosso, D, Bigolin, R, Vanzuita, R, Prado, LF, Oliveira, V, Reis, DL, Morais, MO, Bastos, RS, Santana, HS, Silva, AO, Cacau, LA, Almeida, MS, Canavessi, HS, Nogueira, EE, Pavia, CL, Araujo, JF, Lira, JA, Nienstedt, EC, Smith, TC, Romano, M, Barros D, Costa, AF, Takahashi, L, Werneck, V, Farran, J, Henriques, LA, Miura, C, Lopes, RD, Vendrame, LS, Sandri, P, Galassi, MS, Amato, P, Toufen, C Jr, Santiago, RR, Hirota, AS, Park, M, Azevedo, LC, Malbouison, LM, Costa, MC, Taniguchi, L, Pompílio, CE, Baruzzi, C, Andrade, AH, Taira, EE, Taino, B, Oliveira, CS, Silva, AC, Ísola, A, Rezende, E, Rodrigues, RG, Rangel, VP, Luzzi, S, Giacomassi, IW, Nassar, AP Jr, Souza, AR, Rahal, L, Nunes, AL, Giannini, F, Menescal, B, Morais, JE, Toledo, D, Morsch, RD, Merluzzi, T, Amorim, DS, Bastos, AC, Santos, PL, Silva, SF, Gallego, RC, Santos, GD, Tucci, M, Costa, RT, Santos, LS, Demarzo, SE, Schettino, GP, Suzuki, VC, Patrocinio, AC, Martins, ML, Passos, DB, Cappi, SB, Gonçalves, I Jr, Borges, MC, Lovato, W, Tavares, MV, Morales, D, Machado, LA, Torres, FC, Gomes, TM, Cerantola, RB, Góis, A, Marraccini, T, Margarida, K, Cavalcante, E, Machado, FR, Mazza, BF, Santana, HB, Mendez, VM, Xavier, PA, Rabelo, MV, Schievano, FR, Pinto, WA, Francisco, RS, Ferreira, EM, Silva, DC, Arduini, RG, Aldrighi, JR, Amaro, AF, Conde, KA, Pereira, CA, Tarkieltaub, E, Oliver, WR, Guadalupe, EG, Acerbi, PS, Tomizuka, CI, Oliveira, TA, Geha, NN, Mecatti, GC, Piovesan, MZ, Salomão, MC, Moreno, MS, Orsatti, VN, Miranda, W, Ray, A, Guerra, A, Filho, ML, Ferreira, FH Jr, Filho, EV, Canzi, RA, Giuberti, AF, Garcez, MC, Sala, AD, Suguitani, EO, Kazue, P, Oliveira, LR, Infantini, RM, Carvalho, FR, Andrade, LC, Santos, TM, Carmona, CV, Figueiredo, LC, Falcão, A, Dragosavak, D, Filho, WN, Lunardi, MC, Lago, R, Gatti, C, Chiasso, TM, Santos, GO, Araujo, AC, Ornellas, IB, Vieira, VM, Hajjar, LA, Figueiredo, AC, Damasceno, B, Hinestrosa, A, Diaz-Quijano, FA, Raineri, SM, and Cortegiani, A

Subjects
Research design, ARDS, medicine.medical_specialty, Time Factors, Ventilator-Induced Lung Injury, Alveolar recruitment, Treatment outcome, Randomized, Medicine (miscellaneous), Settore MED/41 - Anestesiologia, Hospital mortality, law.invention, Positive-Pressure Respiration, Study Protocol, Mechanical ventilation, Clinical trials, Randomized controlled trial, Clinical Protocols, law, Medicine, Humans, Pharmacology (medical), Hospital Mortality, PEEP, Protocol (science), Respiratory Distress Syndrome, Acute respiratory distress syndrome, business.industry, respiratory system, Length of Stay, medicine.disease, Clinical trial, Pulmonary Alveoli, Intensive Care Units, Treatment Outcome, Multicenter study, Barotrauma, Research Design, Physical therapy, business, Brazil
Abstract

Background Acute respiratory distress syndrome (ARDS) is associated with high in-hospital mortality. Alveolar recruitment followed by ventilation at optimal titrated PEEP may reduce ventilator-induced lung injury and improve oxygenation in patients with ARDS, but the effects on mortality and other clinical outcomes remain unknown. This article reports the rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART). Methods/Design ART is a pragmatic, multicenter, randomized (concealed), controlled trial, which aims to determine if maximum stepwise alveolar recruitment associated with PEEP titration is able to increase 28-day survival in patients with ARDS compared to conventional treatment (ARDSNet strategy). We will enroll adult patients with ARDS of less than 72 h duration. The intervention group will receive an alveolar recruitment maneuver, with stepwise increases of PEEP achieving 45 cmH2O and peak pressure of 60 cmH2O, followed by ventilation with optimal PEEP titrated according to the static compliance of the respiratory system. In the control group, mechanical ventilation will follow a conventional protocol (ARDSNet). In both groups, we will use controlled volume mode with low tidal volumes (4 to 6 mL/kg of predicted body weight) and targeting plateau pressure ≤30 cmH2O. The primary outcome is 28-day survival, and the secondary outcomes are: length of ICU stay; length of hospital stay; pneumothorax requiring chest tube during first 7 days; barotrauma during first 7 days; mechanical ventilation-free days from days 1 to 28; ICU, in-hospital, and 6-month survival. ART is an event-guided trial planned to last until 520 events (deaths within 28 days) are observed. These events allow detection of a hazard ratio of 0.75, with 90% power and two-tailed type I error of 5%. All analysis will follow the intention-to-treat principle. Discussion If the ART strategy with maximum recruitment and PEEP titration improves 28-day survival, this will represent a notable advance to the care of ARDS patients. Conversely, if the ART strategy is similar or inferior to the current evidence-based strategy (ARDSNet), this should also change current practice as many institutions routinely employ recruitment maneuvers and set PEEP levels according to some titration method. Trial registration ClinicalTrials.gov Identifier: NCT01374022

Published
2012

6. Relationship of anthropometric measurements and percent body fat mass to cardiovascular disease risk factors in adults with cerebral palsy.

Author

Kivlehan E, Gaebler-Spira D, Chen L, Garrett A, Wysocki N, and Marciniak C

Subjects
Humans, Adult, Risk Factors, Glycated Hemoglobin, Cross-Sectional Studies, Body Mass Index, Adipose Tissue, Cardiovascular Diseases epidemiology, Cerebral Palsy complications
Abstract

Introduction: Adults with cerebral palsy (CP) face high morbidity from cardiovascular disease (CVD). Of concern, classic screening parameters are inconsistent in identifying CVD risk in this population. Dual-energy x-ray absorptiometry (DEXA), which provides direct measurements of fat mass (FM), may be an alternative screening method., Objective: To evaluate whether FM measurement with DEXA is feasible in screening adults with CP and compare FM and anthropometric measures to CVD risk factors., Design: Cross-sectional study., Setting: Outpatient rehabilitation hospital., Participants: Forty-seven adults with CP., Main Outcome Measures: Weight, height, waist circumference (WC), and hip circumference (HC) were measured; waist-to-hip ratio (WHR) and body mass index (BMI) were calculated. Blood pressure (BP), FM by DEXA, hemoglobin A1c (HbA1c), and lipid measurements were obtained. Logistic regression models investigated odds ratios (ORs) and 95% confidence intervals (CIs) between anthropometric measurements/FM and CVD risk factors; correlations were assessed using Pearson correlation coefficients., Results: Elevated BP or hypertension diagnosis was present in 47.8%; HbA1c ≥5.7% in 22.2%; and high-density lipoprotein (HDL) level below optimal for 33.3%. DEXA FM was obtained in 29 of 47 participants, as surgical metal and positioning limited many studies. Excess FM was noted in 75.9% versus 41.3% overweight/obese by BMI. WC correlated with HbA1c (r = 0.46, p = .002), HDL (r = -0.36, p = .018), and triglyceride (TG) levels (r = 0.30, p = .045); however at-risk WC values were associated only with odds of elevated HbA1c (OR 8.53, 95% CI 1.46-50.05; p = .018). HC correlated with HbA1c levels (r = 0.38, p = .011) and systolic BPs (r = 0.35, p = .019); similarly, ORs for elevated HC were weakly associated with elevated HbA1c and BPs (OR 1.08, 95% CI 1.01-1.16; p = .024 and OR 1.07, 95% CI 1.01-1.14; p = .024, respectively). WHR correlated with TGs; however few TG levels were elevated. FM measures were not associated with at-risk lab values or BPs., Conclusions: DEXA FM measurements may not be feasible for CVD screening in many adults with CP. Although CVD risk factors are frequently present, anthropometric measurements commonly used for general population screening may not translate well to adults with CP., (© 2022 American Academy of Physical Medicine and Rehabilitation.)

Published
2023
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7. Calcaneal quantitative ultrasound compared with hip and femoral neck dual-energy x-ray absorptiometry in people with a spinal cord injury.

Author

Schnitzer TJ, Wysocki N, Barkema D, Griffith J, Lent V, Romba M, Welbel R, Bhuva S, Manyam B, and Linn S

Subjects
Absorptiometry, Photon, Adult, Bone Density physiology, Cross-Sectional Studies, Female, Humans, Logistic Models, Lumbar Vertebrae diagnostic imaging, Male, ROC Curve, Registries, Retrospective Studies, Sensitivity and Specificity, Ultrasonography, Calcaneus diagnostic imaging, Femur Neck diagnostic imaging, Hip Joint diagnostic imaging, Osteoporosis diagnosis, Spinal Cord Injuries physiopathology
Abstract

Objective: To evaluate the sensitivity and specificity of calcaneal quantitative ultrasound (QUS) measurements for identifying osteoporosis determined by dual-energy x-ray absorptiometry (DXA) at the hip in a spinal cord injury (SCI) population., Design: Cross-sectional retrospective review of data collected in the bone health registry of persons with a disability., Setting: Inpatients and outpatients at a single acute rehabilitation hospital., Participants: A convenience sample of 66 participants, both inpatients and outpatients, with a spinal cord injury., Methods: Calcaneal T scores were determined by ultrasound, and bone density of the lumbar spine, total hip, and femoral neck were determined by DXA., Main Outcome Measurements: Right and left calcaneal QUS T scores and right and left hip and femoral neck DXA T scores., Results: Right and left hip DXA T scores were strongly associated with corresponding right and left calcaneal QUS T scores (right: r = .72, P < .001; left: r = .70, P < .001). Similar associations were found when we evaluated femoral neck T scores and calcaneal QUS T scores. Receiver operating characteristic analysis for evaluating QUS to identify DXA-defined osteoporosis demonstrated an area under the curve of 0.81 for all participants (acute and chronic injury) and 0.68 for those with a chronic SCI., Conclusions: A strong association exists between calcaneal QUS T scores and bone density T scores at the hip measured by DXA. QUS may have a place in the screening of people with SCI 1 year or more after their injury to evaluate their bone status., (Copyright © 2012 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.)

Published
2012
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