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Trials
Published in: Trials 1/2009

Open Access 01-12-2009 | Study protocol

Wean Earlier and Automatically with New technology (the WEAN study): a protocol of a multicentre, pilot randomized controlled trial

Authors: Karen EA Burns, Maureen O Meade, Martin R Lessard, Sean P Keenan, Francois Lellouche

Published in: Trials | Issue 1/2009

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Abstract

Background

Weaning is the process during which mechanical ventilation is withdrawn and the work of breathing is transferred from the ventilator back to the patient. Prolonged weaning is associated with development of ventilator-related complications and longer stays in the Intensive Care Unit (ICU). Computerized or Automated Weaning is a novel weaning strategy that continuously measures and adapts ventilator support (by frequently measuring and averaging three breathing parameters) and automatically conducts Spontaneous Breathing Trials to ascertain whether patients can resume autonomous breathing. Automated Weaning holds promise as a strategy to reduce the time spent on the ventilator, decrease ICU length of stay, and improve clinically important outcomes.

Methods/Design

A pilot weaning randomized controlled trial (RCT) is underway in the ICUs of 8 Canadian hospitals. We will randomize 90 critically ill adults requiring invasive ventilation for at least 24 hours and identified at an early stage of the weaning process to either Automated Weaning (SmartCare™) or Protocolized Weaning. The results of a National Weaning Survey informed the design of the Protocolized Weaning arm. Both weaning protocols are operationalized in Pressure Support mode, include opportunities for Spontaneous Breathing Trials, and share a common sedation protocol, oxygen titration parameters, and extubation and reintubation criteria. The primary outcome of the WEAN study is to evaluate compliance with the proposed weaning and sedation protocols. A key secondary outcome of the pilot RCT is to evaluate clinician acceptance of the weaning and sedation protocols. Prior to initiating the WEAN Study, we conducted a run-in phase, involving two patients per centre (randomizing the first participant to either weaning strategy and assigning the second patient to the alternate strategy) to ensure that participating centres could implement the weaning and sedation protocols and complete the detailed case report forms.

Discussion

Mechanical ventilation studies are difficult to implement; requiring protocols to be operationalized continuously and entailing detailed daily data collection. As the first multicentre weaning RCT in Canada, the WEAN Study seeks to determine the feasibility of conducting a large scale future weaning trial and to establish a collaborative network of ICU clinicians dedicated to advancing the science of weaning.

Trial Registration Number

ISRCTN43760151
Appendix
Available only for authorised users
Literature
1.
Esteban A, Alia I, Ibanez J, Benito S, Tobin MJ: Modes of mechanical ventilation and weaning. A national survey of Spanish hospitals. The Spanish Lung Failure Collaborative Group. Chest. 1994, 106 (4): 1188-93. 10.1378/chest.106.4.1188.CrossRefPubMed
2.
Esteban A, Anzueto A, Frutos F: Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002, 287 (3): 345-55. 10.1001/jama.287.3.345.CrossRefPubMed
3.
4.
Niederman MS, Ferranti RD, Ziegler A: Respiratory infection complicating long-term tracheostomy: the implication of persistent gram negative trachobronchial colonization. Chest. 1984, 85: 39-44. 10.1378/chest.85.1.39.CrossRefPubMed
5.
Heyland DK, Cook DJ, Griffith L: The attributable morbidity and mortality of venetilator associated pneumonia in the critically ill patient. Am J Respir Crit Care Med. 1999, 159: 1249-56.CrossRefPubMed
6.
Dasta JF, McLaughlin TP, Mody SH, Tak Piech C: Daily cost of an intensive care unit day: the contribution of mechanical ventilation. Crit Care Med. 2005, 33: 1266-71. 10.1097/01.CCM.0000164543.14619.00.CrossRefPubMed
7.
MacIntyre NR, Cook DJ, Ely EW: Evidence-based guidelines for weaning and discontinuing ventilator support. A collective task force facilitated by the American College of Chest Physicians, the American Association for Respiratory Care; and the American College of Critical Care Medicine. Chest. 2001, 120 (6 Suppl): 375-95S. 10.1378/chest.120.6_suppl.375S.CrossRef
8.
Ely EW, Baker AM, Dunagan DP: Effect of the duration of mechanical ventilation on identifying patients capable of breathing spontaneously. N Engl J Med. 1996, 335: 1864-9. 10.1056/NEJM199612193352502.CrossRefPubMed
9.
Kollef MH, Shapiro SD, Silver P: A randomized, controlled trial of protocol-directed versus physician-directed weaning from mechanical ventilation. Crit Care Med. 1997, 25: 567-74. 10.1097/00003246-199704000-00004.CrossRefPubMed
10.
Marelich GP, Murin S, Battistella F: Protocol weaning of mechanical ventilation in medical and surgical patients by respiratory care practitioners and nurses. Effect on weaning time and incidence of ventilator associated pneumonia. Chest. 2000, 118: 459-67. 10.1378/chest.118.2.459.CrossRefPubMed
11.
Esteban A, Alia I, Gordo F: Extubation outcome after spontaneous breathing trials with t-tube or pressure support ventilation. Am J Respir Crit Care Med. 1997, 156: 459-65.CrossRefPubMed
12.
Esteban A, Alia I, Tobin MJ: Effect of spontaneous breathing trial duration on outcome of attempts to discontinue mechanical ventilation. Am J Respir Crit Care Med. 1999, 159: 512-8.CrossRefPubMed
13.
Perren A, Domenighetti G, Mauri S, Genini F, Vizzardi N: Protocol-directed weaning from mechanical ventilation; clinical outcome in patients randomized for a 30-minute and 120-minute trial with pressure support. Intensive Care Med. 2002, 28: 1058-63. 10.1007/s00134-002-1353-z.CrossRefPubMed
14.
Brochard L, Rauss A, Benito S: Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med. 1994, 150: 896-903.CrossRefPubMed
15.
Esteban A, Frutos F, Tobin MJ: A comparison of four methods of weaning patients from mechanical ventilation. N Engl J Med. 1995, 332: 345-50. 10.1056/NEJM199502093320601.CrossRefPubMed
16.
Esen F, Denkel T, Telci L: Comparison of pressure support ventilation and intermittent mandatory ventilation during weaning in patients with acute respiratory failure. Adv Exp Med Biol. 1992, 317: 371-6.CrossRefPubMed
17.
Ely EW, Bennett PA, Bowton DL, Murphy SM, Florance AM, Haponik EF: Large scale implementation of a respiratory therapist-driven protocol for ventilator weaning. Am J Respir Crit Care Med. 1999, 159 (2): 439-46.CrossRefPubMed
18.
Vitacca M, Clini E, Porta R, Ambrosino N: Preliminary results on nursing workload in a dedicated weaning center. Intensive Care Med. 2000, 26 (6): 796-9. 10.1007/s001340051249.CrossRefPubMed
19.
Burns K, Lellouche F, Lessard M: Automating the weaning process with advanced closed-loop systems. Intensive Care Med. 2008, 34 (10): 1757-65. 10.1007/s00134-008-1154-0. Epub2008 Jun 3.CrossRefPubMed
20.
Dojat M, Brochard L, Lemaire F, Harf A: A knowledge-based system for assisted ventilation of patients in intensive care units. Int J Clin Monit Comput. 1992, 9 (4): 239-50. 10.1007/BF01133619.CrossRefPubMed
21.
Dojat M, Brochard L: Knowledge-based systems for automatic ventilatory management. Respir Care Clin N Am. 2001, 7 (3): 379-96. 10.1016/S1078-5337(05)70048-4. viii.CrossRefPubMed
22.
Dojat M, Harf A, Touchard D, Laforest M, Lemaire F, Brochard L: Evaluation of a knowledge-based system providing ventilatory management and decision for extubation. Am J Respir Crit Care Med. 1996, 153 (3): 997-1004.CrossRefPubMed
23.
Dojat M, Harf A, Touchard D, Lemaire F, Brochard L: Clinical evaluation of a computer-controlled pressure support mode. Am J Respir Crit Care Med. 2000, 161 (4 Pt 1): 1161-6.CrossRefPubMedPubMedCentral
24.
Bouadma L, Lellouche F, Cabello B: Use of an automated control system to adapt the level of pressure support and manage weaning. Intensive Care Med. 2002, 28 (1): S23-
25.
Lellouche F, Mancebo J, Jolliet RJP: Computer-driven ventilation reduces duration of weaning: a multicenter randomized controlled study. Intensive Care Med. 2004, 30: S69-
26.
Rose L, Presneill JJ, Johnston L, Cade JF: A randomized, controlled trial of conventional versus automated weaning from mechanical ventilation using SmartCare/PS. Intensive Care Med. 2008, 34 (10): 1788-95. 10.1007/s00134-008-1179-4. Epub2008 Jun 25.CrossRefPubMed
27.
Jaber S, Pigeot J, Fodil R, Maggiore S, Harf A, Isabey D, Brochard L: Long-term Effects of Different Humidification Systems on Endotracheal Tube Patency. Anesthesiology. 2004, 100: 782-8. 10.1097/00000542-200404000-00006.CrossRefPubMed
28.
Boots RL, George N, Faoagali JL, Druery J, Dean K, Heller RF: Double-heater-wire circuits and heat-and-moisture exchangers and the risk of ventilator-associated pneumonia. Crit Care Med. 34: 687-93. 10.1097/01.CCM.0000201887.51076.31.
29.
Girault C, Breton L, Richard JC, Tamion F, Vandelet P, Aboab J, Leroy J, Bonmarchand G: Mechanical effects of airway humidification devices in difficult to wean patients. Crit Care Med. 2003, 31: 1306-11. 10.1097/01.CCM.0000063284.92122.0E.CrossRefPubMed
30.
Iotti GA, Olivei MC, Braschi A: Mechanical effects of heat-moisture exchangers in ventilated patients. Crit Care. 1999, 3: R77-82. 10.1186/cc361. Epbu1999 Sept 23.CrossRefPubMedPubMedCentral
31.
Pauwels R, Buist S, Calverly P: Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease. NHLBI/WHO Global Initiative for Chronic Obstuctive Lung Disease (GOLD) Workshop Summary. Am J Respir Crit Care Med. 2001, 163: 1256-76.CrossRefPubMed
32.
Bourbeau J, Nault D, Borycki E, editors: Assessment of COPD. Comprehensive Management of Chronic Obstructive Pulmonary Disease. 2002, Philadelphia: BC Decker
33.
Riker RR, Picard JT, Fraser GL: Prospective evaluation of the Sedation-Agitation Scale for adult critically ill patients. Crit Care Med. 1999, 27 (7): 1325-9. 10.1097/00003246-199907000-00022.CrossRefPubMed
34.
Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK: The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002, 166 (10): 1338-44. 10.1164/rccm.2107138.CrossRefPubMed
35.
Brook AD, Ahrens TS, Schaiff R: Effect of a nursing-implemented sedation protocol on the duration of mechanical ventilation. Crit Care Med. 1999, 27: 2609-15. 10.1097/00003246-199912000-00001.CrossRefPubMed
36.
Keenan SP, Powers C, McCormack DG, Block G: Noninvasive Positive-Pressure Ventilation for Postextubation Respiratory Distress. JAMA. 2002, 287 (24): 3238-3244. 10.1001/jama.287.24.3238.CrossRefPubMed
37.
Esteban A, Frutos-Vivar F, Ferguson ND: Noninvasive positive-pressure ventilation for respiratory failure after extubation. N Engl J Med. 2004, 350 (24): 2452-60. 10.1056/NEJMoa032736.CrossRefPubMed
38.
Brochard L, Mancebo J, Wysocki M: Noninvasive ventilation for acute exacerbations of chronic obstructive pulmonary disease. N Engl J Med. 1995, 333 (13): 817-22. 10.1056/NEJM199509283331301.CrossRefPubMed
39.
Pugin J, Auckenthaler R, Mili N: Diagnosis of ventilator-associated pneumonia by bacteriologic analysis of bronchosciopic and nonbronchoscopic "blind" bronchoalveolar lavage. Am Rev Respir Dis. 1991, 143: 1121-9.CrossRefPubMed
40.
Elder JP, Artz LM, Beaudin P: Multivariate evaluation of health attitudes and behaviors: development and validation of a method for health promotion research. Prev Med. 1985, 14: 34-54. 10.1016/0091-7435(85)90019-2.CrossRefPubMed
41.
Multz AS, Chalfin DG, Samson IM: A "closed" medical intensive care unit improves resource utilization when compared to an "open" MICU. Am J Respir Crit Care Med. 1998, 157: 1468-73.CrossRefPubMed
42.
Needham D, Bronskill SE, Calinawan JR: Projected incidence of mechanical ventilation in Ontario to 2026: Preparing for the aging baby boomers. Crit Care Med. 2005, 33: 574-9. 10.1097/01.CCM.0000155992.21174.31.CrossRefPubMed
43.
Guyatt GH, Montori VM, Deveraux PJ: Patients at the center: In our practice and in our use of language (Editorial). ACP Journal Club. 2004, 140: A11-PubMed
44.
Arnold DM, Burns KE, Adhikari NK, Kho ME, Meade MO, Cook DJ: The design and interpretation of pilot trials in clinical research in critical care. Crit Care Med. 2009, 1 (Suppl): S69-74. 10.1097/CCM.0b013e3181920e33.CrossRef
45.
Burns KE, Duffett M, Kho ME, Meade MO, Adhikari NK, Sinuff T, Cook DJ, ACCADEMY Group: A guide for the design and conduct of self-administered surveys of clinicians. CMAJ. 2008, 179 (3): 245-52.CrossRefPubMedPubMedCentral
46.
Burns KEA, Lellouche F, Loisel F, Slutsky AS, Meret A, Smith O, Saskin R, Meade MO, for the Canadian Critical Care Trials Group: Weaning Critically Ill Adults from Invasive Mechanical Ventilation: A National Survey.
Metadata
Title
Wean Earlier and Automatically with New technology (the WEAN study): a protocol of a multicentre, pilot randomized controlled trial
Authors
Karen EA Burns
Maureen O Meade
Martin R Lessard
Sean P Keenan
Francois Lellouche
Publication date
01-12-2009
Publisher
BioMed Central
Published in
Trials / Issue 1/2009
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-10-81

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