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2. Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): study protocol for a randomized controlled trial
- Author
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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
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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
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- 2012
3. [Nutrition and physical activity counseling practice and adherence of primary care users].
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Santos RP, Horta PM, Souza CS, dos Santos CA, de Oliveira HB, de Almeida LM, and dos Santos LC
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- Cross-Sectional Studies, Female, Humans, Male, Middle Aged, Diet, Directive Counseling, Exercise, Motor Activity, Patient Compliance, Primary Health Care
- Abstract
The present study aimed to investigate counseling content provided by healthcare professional for primary healthcare users, as well as users' difficulties in adhering to the counseling, through a cross-sectional study design. Interviews were conducted with 499 users at a primary healthcare unit and 59.3% of them said that counseling had been provided especially by physicians (93.6%), and it was based on healthy nutrition and physical activity practice (48.9%). Counseling was more frequently to users with greater numbers of morbid conditions (p = 0.001). The main factors that made adherence difficult for users were lack of time (27.5%) and the need to change habits (23%). It was identified that counseling is still at initial stage within primary care, and there is a need for healthcare professionals, especially the nurse of the family health team to be more proactive in this process,focusing mainly on health promotion.
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- 2012
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4. Effect of epilepsy and sleep deprivation on the rate of benign epileptiform transients of sleep.
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Molaie M, Santana HB, Otero C, and Cavanaugh WA
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- Adolescent, Adult, Aged, Anticonvulsants therapeutic use, Brain physiopathology, Epilepsy drug therapy, Female, Humans, Male, Middle Aged, Electroencephalography, Epilepsy physiopathology, Sleep Deprivation physiology, Sleep Stages physiology
- Abstract
Seventy-eight individuals with EEG records containing benign epileptiform transients of sleep (BETS) were identified among 7,400 records reviewed in our laboratory in a 6-year period. The records contained no other abnormality in 51 patients (65%). Genuine epileptiform discharges were found in the records of 19 patients; 14 had a history of epilepsy. Thirty-five patients (45%) had a proven history of epilepsy with antiepileptic drug (AED) therapy. In the records of these patients, the mean number of BETS per unit of time was significantly higher (11.88 +/- 2) than in the record of the rest of the laboratory population with BETS (6.89 +/- 0.9) (p less than 0.02). Among five conventional surface montages, ipsilateral ear referential montage (IERM) showed a significantly higher number of BETS per unit of time than did any other surface montage used in the study. Thirty-nine records (50%) were performed after sleep deprivation (SD). When only IERM was considered, SD records showed a significantly higher number of BETS per unit of time (7.36 +/- 1.1) than did non-SD records (3.89 +/- 0.69) (p less than 0.01). Our findings support the general consensus that individual BETS may be normal variants, but a high occurrence of BETS in the record should raise suspicion of underlying epilepsy.
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- 1991
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5. Treatment of "emotional incontinence" with levodopa.
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Wolf JK, Santana HB, and Thorpy M
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- Humans, Emotions drug effects, Levodopa therapeutic use
- Published
- 1979
- Full Text
- View/download PDF
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