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CompletedNCT01573481REVENTILUpdated Sep 19, 2025

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

An interventional study of pressure support ventilation and Pressure controlled ventilation in Weaning Failure and COPD Exacerbation, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Weaning Failure
  • COPD Exacerbation

Keywords

  • WEANING
  • PRESSURE CONTROLLED CONTINOUS VENTILATION
  • PRESSURE VENTILATION SUPPORT
  • SLEEP
  • POLYGRAPHIC RECORD
03

In context

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • sleep apnea, central
  • narcolepsy
  • Encephalopathy, Metabolic AND Encephalitis
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
19 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Otherpressure 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.

  • OtherPressure 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).

06

What researchers measure

Primary outcomes

  1. Weaning duration

    weaning duration in days (from the first day with spontaneous ventilation to extubation)

    Time frame: between one to 21 days (the study will begin when patient presents weaning criteria and will stop 48 days after extubation.)

Secondary outcomes

  1. 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

    Time frame: 48 hours

  2. 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.

    Time frame: 1 to 21 days

07

Study locations

1 site
  • Pneumologie et Réanimation Respiratoire
    Amiens, 80000, France
08

References and documents

Publications

  • 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. PubMed 17470624 ↗
  • 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. PubMed 9228375 ↗
  • 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. PubMed 7921460 ↗
  • 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. PubMed 7823995 ↗
  • 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. PubMed 9840232 ↗
  • 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. PubMed 3921096 ↗
  • 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. PubMed 1050357 ↗
  • 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. PubMed 11179121 ↗
  • Schwab RJ. Disturbances of sleep in the intensive care unit. Crit Care Clin. 1994 Oct;10(4):681-94. PubMed 8000921 ↗
  • 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. PubMed 12406837 ↗
  • 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. PubMed 9367467 ↗
  • 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. PubMed 8970381 ↗
  • 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. PubMed 17334259 ↗
  • 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. PubMed 17492431 ↗
  • 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. PubMed 3928249 ↗
  • 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. PubMed 8254858 ↗
  • 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. PubMed 8844239 ↗
  • 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. PubMed 4136544 ↗
  • 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. PubMed 290137 ↗
  • 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. PubMed 10446827 ↗
  • Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656. PubMed 4835444 ↗
  • 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. PubMed 8181279 ↗
  • 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. PubMed 23391488 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01573481
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Apr 9, 2012
Start date
Jan 2012
Primary completion
Jan 2015
Completion
Jan 2015
Last update
Sep 19, 2025

Study contacts

ANDREJAK Claire, MD
principal investigator · CHU Amiens
JOUNIEAUX Vincent, MD PhD
study director · CHU Amiens
BASILLE Damien, MD
principal investigator · CHU Amiens
ROGER Pierre-Alexandre, MD
principal investigator · CHU Amiens
ROSE Dominique, MD
principal investigator · CHU Amiens
MONCONDUIT Julien, MD
principal investigator · CHU Amiens

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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