Comparison of Two Ventilator Mode During the Night: New Strategy of Mechanical Ventilation Weaning (REVENTIL)

Pressure Controlled Ventilation Versus Pressure Support Ventilation During the Night: New Strategy of Mechanical Ventilation Weaning?

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.

Study Overview

• Status: Completed
• Conditions: COPD Exacerbation; Weaning Failure
• Intervention / Treatment: Other: pressure support ventilation; Other: Pressure controlled ventilation

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80000
    • Pneumologie et Réanimation Respiratoire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The patient and/or legal representative of the patient has provided a written informed consent before inclusion in the study
• The patients is hospitalized in respiratory and critical care unit (university hospital of AMIENS, FRANCE)
• the patient is mechanically ventilated (ventilator model : puritan-bennett B840)
• Pulmonary disease,chronic obstructive (Spirometry and Blood Gas Analysis in chronic state before admission)
• stable cardiovascular status (cardiac frequency < 140 beats/min and systolic blood pressure : 90-160 mmHg without catecholamines)
• midazolam < 0,05mg/kg/h
• sufentanyl < 0,05µ/kg/h
• the disorder that caused respiratory failure and prompted mechanical ventilation is treated
• the clinician suspects the patient may be ready to begin the weaning process
• inspiratory oxygen fraction (FiO2) < 50%
• positive end-expiratory pressure < or equal 8cmH2O
• during the day, the patient tolerate pressure support ventilation (pressure support level < 15cmH2O
• respiratory frequency (FR) < 35 breaths/min
• tidal volume (VT) > 5ml/kg
• PaO2/FiO2 > 200 mmHg
• FR/VT < 105 breaths/min/L

Exclusion Criteria:

• sleep apnea, central
• narcolepsy
• Encephalopathy, Metabolic AND Encephalitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pressure support ventilation; 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).	Other: pressure support ventilation; 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.
Active Comparator: Pressure controlled ventilation; 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).	Other: Pressure controlled ventilation; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.)

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: ANDREJAK Claire, MD, CHU Amiens; Study Director: JOUNIEAUX Vincent, MD PhD, CHU Amiens; Principal Investigator: 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

Publications and helpful links

General Publications

• Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.
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• 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.
• 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.
• Riker RR, Picard JT, Fraser GL. Prospective evaluation of the Sedation-Agitation Scale for adult critically ill patients. Crit Care Med. 1999 Jul;27(7):1325-9. doi: 10.1097/00003246-199907000-00022.
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• 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.
• Aurell J, Elmqvist D. Sleep in the surgical intensive care unit: continuous polygraphic recording of sleep in nine patients receiving postoperative care. Br Med J (Clin Res Ed). 1985 Apr 6;290(6474):1029-32. doi: 10.1136/bmj.290.6474.1029.
• 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.
• 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.
• Teasdale G, Jennett B. Assessment of coma and impaired consciousness. A practical scale. Lancet. 1974 Jul 13;2(7872):81-4. doi: 10.1016/s0140-6736(74)91639-0. No abstract available.
• 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.
• 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.
• Teasdale G, Murray G, Parker L, Jennett B. Adding up the Glasgow Coma Score. Acta Neurochir Suppl (Wien). 1979;28(1):13-6. doi: 10.1007/978-3-7091-4088-8_2. No abstract available.
• Le Gall JR, Lemeshow S, Saulnier F. A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study. JAMA. 1993 Dec 22-29;270(24):2957-63. doi: 10.1001/jama.270.24.2957.
• 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.
• Hilton BA. Quantity and quality of patients' sleep and sleep-disturbing factors in a respiratory intensive care unit. J Adv Nurs. 1976 Nov;1(6):453-68. doi: 10.1111/j.1365-2648.1976.tb00932.x. No abstract available.
• Schwab RJ. Disturbances of sleep in the intensive care unit. Crit Care Clin. 1994 Oct;10(4):681-94.
• 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.
• 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.
• 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.
• Hansen-Flaschen J, Cowen J, Polomano RC. Beyond the Ramsay scale: need for a validated measure of sedating drug efficacy in the intensive care unit. Crit Care Med. 1994 May;22(5):732-3. No abstract available.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: February 22, 2012
• First Submitted That Met QC Criteria: April 5, 2012
• First Posted (Estimated): April 9, 2012

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: SLEEP; WEANING; PRESSURE CONTROLLED CONTINOUS VENTILATION; PRESSURE VENTILATION SUPPORT; POLYGRAPHIC RECORD
• Other Study ID Numbers: PI2012_843_0016