Weaning FailureREVENTILNCT01573481
Comparison of Two Ventilator Mode During the Night: New Strategy of Mechanical Ventilation Weaning
A study testing pressure support ventilation in people with Weaning Failure and COPD Exacerbation, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning Failure, COPD Exacerbation
- What is being tested?
- pressure support ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- sleep apnea, central
- narcolepsy
- Encephalopathy, Metabolic AND Encephalitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Weaning Failure, COPD Exacerbation
- Being tested
- pressure support ventilation, Pressure controlled ventilation
- Keywords
- WEANING, PRESSURE CONTROLLED CONTINOUS VENTILATION, PRESSURE VENTILATION SUPPORT, SLEEP, POLYGRAPHIC RECORD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pressure support ventilationOther
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.
Pressure controlled ventilationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: pressure support ventilation |
| 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). Receives: Other: Pressure controlled ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weaning duration
weaning duration in days (from the first day with spontaneous ventilation to extubation)
Measured: between one to 21 days (the study will begin when patient presents weaning criteria and will stop 48 days after extubation.)
Secondary outcomes (2)
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
Measured: 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.
Measured: 1 to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Weaning FailureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ANDREJAK Claire, MD, Principal investigator, CHU AmiensJOUNIEAUX Vincent, MD PhD, Study director, CHU AmiensBASILLE Damien, MD, Principal investigator, CHU AmiensROGER Pierre-Alexandre, MD, Principal investigator, CHU AmiensROSE Dominique, MD, Principal investigator, CHU AmiensMONCONDUIT Julien, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573481
- Sponsor's protocol ID
- PI2012_843_0016
- Acronym
- REVENTIL
- Status last verified
- Sep 2025
- First submitted
- 22 Feb 2012
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
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 17470624Epstein 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 9228375Brochard 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 7921460Esteban 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 7823995Esteban 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 9840232Aurell 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 3921096Hilton 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 1050357Freedman 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 11179121Schwab RJ. Disturbances of sleep in the intensive care unit. Crit Care Clin. 1994 Oct;10(4):681-94.
PubMed 8000921Parthasarathy 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 12406837Parreira 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 9367467Parreira 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 8970381Bosma 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 17334259Toublanc 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 17492431Knaus 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Controlled Ventilation Versus Pressure Support Ventilation During the Night: New Strategy of Mechanical Ventilation Weaning?
- ClinicalTrials.gov ID
- NCT01573481
- Acronym / sponsor ID
- REVENTIL / PI2012_843_0016
- Conditions
- Weaning Failure, COPD Exacerbation
- Keywords
- WEANING, PRESSURE CONTROLLED CONTINOUS VENTILATION, PRESSURE VENTILATION SUPPORT, SLEEP, POLYGRAPHIC RECORD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 9 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pressure support ventilation | Active comparator | Other: pressure support ventilationPatients 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). |
| Pressure controlled ventilation | Active comparator | Other: Pressure controlled ventilationPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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)
Key exclusion criteria (3 listed)
- sleep apnea, central
- narcolepsy
- Encephalopathy, Metabolic AND Encephalitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pressure support ventilationPatients 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. | Other | Pressure support ventilation |
| Pressure controlled ventilationPatients 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). | Other | Pressure controlled ventilation |
Primary outcome
Weaning duration
Time frame: between one to 21 days (the study will begin when patient presents weaning criteria and will stop 48 days after extubation.)
weaning duration in days (from the first day with spontaneous ventilation to extubation)
2 secondary outcomes
weaning failure
Time frame: 48 hours
Quantity and quality of sleep
Time frame: 1 to 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Background: PubMed 17470624Boles 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.
- Background: PubMed 9228375Epstein 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.
- Background: PubMed 7921460Brochard 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.
- Background: PubMed 7823995Esteban 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.
- Background: PubMed 9840232Esteban 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.
- Background: PubMed 3921096Aurell 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.
- Background: PubMed 1050357Hilton 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.
- Background: PubMed 11179121Freedman 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.
- Background: PubMed 8000921Schwab RJ. Disturbances of sleep in the intensive care unit. Crit Care Clin. 1994 Oct;10(4):681-94.
- Background: PubMed 12406837Parthasarathy 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.
- Background: PubMed 9367467Parreira 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.
- Background: PubMed 8970381Parreira 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ANDREJAK Claire, MD principal investigator
CHU Amiens
JOUNIEAUX Vincent, MD PhD study director
CHU Amiens
BASILLE Damien, MD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pressure support ventilation in people with Weaning Failure and COPD Exacerbation, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weaning duration (time frame: between one to 21 days (the study will begin when patient presents weaning criteria and will stop 48 days after extubation.)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01573481, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.