Chronic Respiratory Failure With Acute Decompensation Requiring Mechanical Ventilation for More Than 48 HoursRehabVentNCT02021227
Early Chair Sitting Exercise in Mechanically Ventilated Critically Ill Patients
A study testing Early chair sitting exercise in people with Chronic Respiratory Failure With Acute Decompensation Requiring Mechanical Ventilation for More Than 48 Hours, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The occurrence of an acute respiratory failure necessitates mostly admission to ICU and mechanical ventilation (MV). Rapid and safe discontinuation of MV should be the objective for the majority of patients. Many reasons may contribute to weaning, extubation failure and prolongation of MV. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Respiratory Failure With Acute Decompensation Requiring Mechanical Ventilation for More Than 48 Hours
- What is being tested?
- Early chair sitting exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2013to 31 Dec 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute respiratory failure
- Requiring mechanical ventilation for more than 48 h
- Informed consent
Who cannot join
- Body mass index > 40 kg/m2
- Severe neuropathy
- Hemodynamic instability, acute cor pulmonary embolism, acute myocardial ischemia/necrosis, hypoxemia
- Deep sedation
Trial locations and contacts
1 site in 1 country.
France1 site
Lapeyronie University Hospital, Intensive Care Department
Montpellier, 34170
About this study
Official title: Effects of Chair Sitting Exercise Intervention on Weaning From Mechanical Ventilation and Mortality of Critically Ill Patients With Acute Respiratory Failure: a Randomised Controlled Trial.
The occurrence of an acute respiratory failure necessitates mostly admission to ICU and mechanical ventilation (MV). Rapid and safe discontinuation of MV should be the objective for the majority of patients. Many reasons may contribute to weaning, extubation failure and prolongation of MV. Critical illness myopathy, induced by immobilisation and prolonged MV, may represent a main factor and early rehabilitation may reverse these conditions and improve the success of weaning from MV.The objective of this study is to evaluate the effect of an early chair sitting (while the patient is awake but still mechanically ventilated) on weaning from mechanical ventilation and ICU mortality.
Methods: Chronic respiratory failure patients with an acute decompensation and requiring MV for more than 48 hours will be randomized to 2 groups at the initiation of weaning schedule: the studied group (20 patients): chair-sitting group will be transferred from bed to arm chair for at least 1 hour and once a day; the control group will stay in bed until extubation. Ventilator free days, extubation failure, nosocomial infections, ICU mortality, ICU length of stay are assessed and compared between groups. Expected results: Early chair sitting would decrease MV duration, number of extubation failure, nosocomial infections and ICU mortality. Feasibility and safety of this intervention will also be evaluated and also the related work load.
- Being tested
- Early chair sitting exercise
- Keywords
- Acute respiratory failure, Mechanical ventilation, Rehabilitation, Exercise chair sitting, Weaning, Chronic respiratory failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early chair sitting exerciseProcedure or surgery
A chair sitting exercise will be done at least once a day and for > 1 hour
| Study group | Role | What they receive |
|---|---|---|
| Standard group | No intervention | Not described |
| Chair sitting group | Other | Not described Receives: Procedure: Early chair sitting exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weaning from mechanical ventilation, mortality
Measured: day 28
Secondary outcomes (3)
ICU length of stay
Measured: day 28
Extubation success
success or failure
Measured: day 28
Nosocomial infections
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study start13 Dec 2013
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Why it stopped: sufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Respiratory Failure With Acute Decompensation Requiring Mechanical Ventilation for More Than 48 HoursStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kada KLOUCHE, MD PhD, Principal investigator, Hopital de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021227
- Sponsor's protocol ID
- 9231
- Acronym
- RehabVent
- Status last verified
- May 2019
- First submitted
- 19 Dec 2013
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Canaud B, Formet C, Raynal N, Amigues L, Klouche K, Leray-Moragues H, Beraud JJ. Vascular access for extracorporeal renal replacement therapy in the intensive care unit. Contrib Nephrol. 2004;144:291-307. doi: 10.1159/000078897. No abstract available.
PubMed 15264418
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chair Sitting Exercise Intervention on Weaning From Mechanical Ventilation and Mortality of Critically Ill Patients With Acute Respiratory Failure: a Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT02021227
- Acronym / sponsor ID
- RehabVent / 9231
- Keywords
- Acute respiratory failure, Mechanical ventilation, Rehabilitation, Exercise chair sitting, Weaning, Chronic respiratory failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sufficient enrollment
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 13 Dec 2013 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 27 Dec 2013 (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 occurrence of an acute respiratory failure necessitates mostly admission to ICU and mechanical ventilation (MV). Rapid and safe discontinuation of MV should be the objective for the majority of patients. Many reasons may contribute to weaning, extubation failure and prolongation of MV. Critical illness myopathy, induced by immobilisation and prolonged MV, may represent a main factor and early rehabilitation may reverse these conditions and improve the success of weaning from MV.The objective of this study is to evaluate the effect of an early chair sitting (while the patient is awake but still mechanically ventilated) on weaning from mechanical ventilation and ICU mortality.
Methods: Chronic respiratory failure patients with an acute decompensation and requiring MV for more than 48 hours will be randomized to 2 groups at the initiation of weaning schedule: the studied group (20 patients): chair-sitting group will be transferred from bed to arm chair for at least 1 hour and once a day; the control group will stay in bed until extubation. Ventilator free days, extubation failure, nosocomial infections, ICU mortality, ICU length of stay are assessed and compared between groups. Expected results: Early chair sitting would decrease MV duration, number of extubation failure, nosocomial infections and ICU mortality. Feasibility and safety of this intervention will also be evaluated and also the related work load.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard group | No intervention | – |
| Chair sitting group | Other | Procedure: Early chair sitting exercise |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute respiratory failure
- Requiring mechanical ventilation for more than 48 h
- Informed consent
Key exclusion criteria (4 listed)
- Body mass index > 40 kg/m2
- Severe neuropathy
- Hemodynamic instability, acute cor pulmonary embolism, acute myocardial ischemia/necrosis, hypoxemia
- Deep sedation
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 |
|---|---|---|
| Early chair sitting exerciseA chair sitting exercise will be done at least once a day and for > 1 hour | Procedure or surgery | Chair sitting group |
Primary outcome
Weaning from mechanical ventilation, mortality
Time frame: day 28
3 secondary outcomes
ICU length of stay
Time frame: day 28
Extubation success
Time frame: day 28
Nosocomial infections
Time frame: day 28
Results and safety
The study was stopped early (reason given: sufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- Results publication: PubMed 15264418Canaud B, Formet C, Raynal N, Amigues L, Klouche K, Leray-Moragues H, Beraud JJ. Vascular access for extracorporeal renal replacement therapy in the intensive care unit. Contrib Nephrol. 2004;144:291-307. doi: 10.1159/000078897. No abstract available.
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.
Kada KLOUCHE, MD PhD principal investigator
Hopital de Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early chair sitting exercise in people with Chronic Respiratory Failure With Acute Decompensation Requiring Mechanical Ventilation for More Than 48 Hours, run by University Hospital, Montpellier 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 24 May 2019. 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 was stopped early (reason given: sufficient enrollment). Results are not available in the source record.
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 from mechanical ventilation, mortality (time frame: day 28). 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 NCT02021227, which also lists 1 linked publication.
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 24 May 2019.