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The purpose of the study is to compare pressure controlled continuous mandatory ventilation versus pressure support ventilation during the night for weaning to mechanical ventilation in chronic obstructive pulmonary disease patients and their impact onto sleep quality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pressure support ventilation | Active Comparator | Patients in this group are ventilated during the night (10 PM to 9 AM) with pressure support ventilation mode. The level of the pressure support is the same as the previous day. During the day (9 AM to 10 PM), patients are ventilated with pressure support ventilation (the level of pressure support is progressively decreased). |
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| Pressure controlled ventilation | Active Comparator | Patients in this group are ventilated during the night (10 PM to 9 AM) with pressure controlled ventilation mode. The level of inspiratory pressure is set to 20 cm H2O and the respiratory rate is adjusted to avoid any spontaneous breathing (respiratory rate > or equal to 12 breath per min). During the day (9 AM to 10 PM), patients are ventilated with pressure support ventilation (the level of pressure support is progressively decreased). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pressure support ventilation | Other | Patients in this group are ventilated during the night with pressure support ventilation mode. The level of the pressure support is the same as the previous day. |
| Measure | Description | Time Frame |
|---|---|---|
| Weaning duration | weaning duration in days (from the first day with spontaneous ventilation to extubation) | between one to 21 days (the study will begin when patient presents weaning criteria and will stop 48 days after extubation.) |
| Measure | Description | Time Frame |
|---|---|---|
| weaning failure | Failure of weaning = re-intubation, necessity of non invative ventilation support for periods during the day time or death, in the first 48 hours following extubation | 48 hours |
| Quantity and quality of sleep |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ANDREJAK Claire, MD | CHU Amiens | Principal Investigator |
| JOUNIEAUX Vincent, MD PhD | CHU Amiens | Study Director |
| BASILLE Damien, MD | CHU Amiens | Principal Investigator |
| ROGER Pierre-Alexandre, MD | CHU Amiens | Principal Investigator |
| ROSE Dominique, MD | CHU Amiens | Principal Investigator |
| MONCONDUIT Julien, MD | CHU Amiens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pneumologie et Réanimation Respiratoire | Amiens | 80000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17470624 | Background | Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206. | |
| 9228375 | Background | Epstein SK, Ciubotaru RL, Wong JB. Effect of failed extubation on the outcome of mechanical ventilation. Chest. 1997 Jul;112(1):186-92. doi: 10.1378/chest.112.1.186. |
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| Pressure controlled ventilation | Other | Patients in this group are ventilated during the night (10 PM to 9 AM) with pressure controlled ventilation mode. The level of inspiratory pressure is set to 20 cm H2O and the respiratory rate is adjusted to avoid any spontaneous breathing (respiratory rate > or equal to 12 breath per min). |
|
Polygraphic datas will be analyzed during weaning, integrating: Proportion of sleep stages (I, II, III, IV, REM sleep), overall sleep and awakeness period.
Average ratio of diurnal sleep on total overall sleep, average ratio of diurnal sleep on total sleep at the first day of weaning and the day before extubation; Observation of central apneas from begining of weaning to extubation.
| 1 to 21 days |
| 7921460 | Background | Brochard L, Rauss A, Benito S, Conti G, Mancebo J, Rekik N, Gasparetto A, Lemaire F. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med. 1994 Oct;150(4):896-903. doi: 10.1164/ajrccm.150.4.7921460. |
| 7823995 | Background | Esteban A, Frutos F, Tobin MJ, Alia I, Solsona JF, Valverdu I, Fernandez R, de la Cal MA, Benito S, Tomas R, et al. A comparison of four methods of weaning patients from mechanical ventilation. Spanish Lung Failure Collaborative Group. N Engl J Med. 1995 Feb 9;332(6):345-50. doi: 10.1056/NEJM199502093320601. |
| 9840232 | Background | Esteban A, Alia I. Clinical management of weaning from mechanical ventilation. Intensive Care Med. 1998 Oct;24(10):999-1008. doi: 10.1007/s001340050708. No abstract available. |
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| 11179121 | Background | Freedman NS, Gazendam J, Levan L, Pack AI, Schwab RJ. Abnormal sleep/wake cycles and the effect of environmental noise on sleep disruption in the intensive care unit. Am J Respir Crit Care Med. 2001 Feb;163(2):451-7. doi: 10.1164/ajrccm.163.2.9912128. |
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| 12406837 | Background | Parthasarathy S, Tobin MJ. Effect of ventilator mode on sleep quality in critically ill patients. Am J Respir Crit Care Med. 2002 Dec 1;166(11):1423-9. doi: 10.1164/rccm.200209-999OC. Epub 2002 Sep 5. |
| 9367467 | Background | Parreira VF, Delguste P, Jounieaux V, Aubert G, Dury M, Rodenstein DO. Effectiveness of controlled and spontaneous modes in nasal two-level positive pressure ventilation in awake and asleep normal subjects. Chest. 1997 Nov 5;112(5):1267-77. doi: 10.1378/chest.112.5.1267. |
| 8970381 | Background | Parreira VF, Delguste P, Jounieaux V, Aubert G, Dury M, Rodenstein DO. Glottic aperture and effective minute ventilation during nasal two-level positive pressure ventilation in spontaneous mode. Am J Respir Crit Care Med. 1996 Dec;154(6 Pt 1):1857-63. doi: 10.1164/ajrccm.154.6.8970381. |
| 17334259 | Background | Bosma K, Ferreyra G, Ambrogio C, Pasero D, Mirabella L, Braghiroli A, Appendini L, Mascia L, Ranieri VM. Patient-ventilator interaction and sleep in mechanically ventilated patients: pressure support versus proportional assist ventilation. Crit Care Med. 2007 Apr;35(4):1048-54. doi: 10.1097/01.CCM.0000260055.64235.7C. |
| 17492431 | Background | Toublanc B, Rose D, Glerant JC, Francois G, Mayeux I, Rodenstein D, Jounieaux V. Assist-control ventilation vs. low levels of pressure support ventilation on sleep quality in intubated ICU patients. Intensive Care Med. 2007 Jul;33(7):1148-1154. doi: 10.1007/s00134-007-0659-2. Epub 2007 May 11. |
| 3928249 | Background | Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29. |
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| 23391488 | Result | Andrejak C, Monconduit J, Rose D, Toublanc B, Mayeux I, Rodenstein D, Jounieaux V. Does using pressure-controlled ventilation to rest respiratory muscles improve sleep in ICU patients? Respir Med. 2013 Apr;107(4):534-41. doi: 10.1016/j.rmed.2012.12.012. Epub 2013 Feb 4. |