Extubation in Intensive Care UnitEXSUPEEPNCT05147636
EXtubation With SUctioning or With Positive End-Expiratory Pressure in Intensive Care Unit
A study testing Extubation with PEEP and Endotracheal Aspiration in people with Extubation in Intensive Care Unit, run by Centre Hospitalier de Bourg en Bresse at 11 sites in France.
Trial summary
Extubation in intensive care unit is a risky situation. Its failure is associated with an increase in the duration of mechanical ventilation and high morbidity and mortality. Our hypothesis is that the extubation procedure associating prior endotracheal aspiration followed by ablation of the intubation probe under the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extubation in Intensive Care Unit
- What is being tested?
- Extubation with PEEP and Endotracheal Aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 425 participants
- Where
- 11 sitesFrance
- Study dates
- 22 Mar 2023to 19 Mar 2025
- 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
- Firstly, the decision to extubate must be made by the treating clinicians after having validated that the clinical criteria for weaning are met, namely: according to the international conference consensus on weaning , patients will be considered as ready for an initial SBT as soon as they meet all of the following criteria:
- respiratory rate ≤35 breaths per minute,
- adequate oxygenation defined as pulse oximetry (SpO2 ≥90%) with a fraction of inspired oxygen (FiO2) ≤0.4 or PaO2/FiO2 ≥150 mmHg with positive end-expiratory pressure ≤8 cm H2O,
- hemodynamic stability with no need for vasopressors (or doses ≤0.3 μg/kg/min),
- adequate cough,
- patient awake with a Richmond Agitation-Sedation Scale between +1 and -2
Show all 12Show fewer
- Patients meeting any of the following criteria will be included in the EXSUPEEP trial:
- ICU Hospitalization
- Oro-tracheal intubation
- Mechanical ventilation for more than 24 h
- First extubation procedure during the stay in the including unit
- Consent collected from a relative of the patient. Once it has been verified that the patient meets all the eligibility criteria listed above, the patient may be extubated after a successful SBT and after obtaining consent from the patient or family.
Who cannot join
- Patients meeting any of the following criteria will be excluded from the EXSUPEEP trial:
- Patients receiving ventilation via tracheostomy.
- Patients with underlying chronic neuromuscular disease
- Patients with severe head injury
- Patients with a decision to withhold and/or withdraw life support
- Patients not affiliated to or beneficiary of any social security scheme.
Show all 11Show fewer
- Person benefiting from enhanced protection, namely minors, pregnant or nursing women, persons deprived of their liberty by a judicial or administrative decision, persons residing in a healthcare or social establishment, adults under legal protection (safeguard of justice, guardianship or curatorship)
- Inclusion in another research project that interferes with the outcomes of the present study
- Weanability criteria not met within 72 hours following the signing of consent by the relatives.
- Unsuccessful weaning test within 72 hours following the signing of consent by the relatives
- Patients with personal NIV or continuous positive airway pressure at home will be included if Pressure Support (PS) and/or PEEP used in the ICU unit are different from the usual settings at home. Regarding infection by SARS-CoV-2 or use of endotracheal tubes with subglottic suction, they do not constitute an exclusion criterion.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CH Annecy Genevois
Annecy
CH Victor Dupouy
Argenteuil
CH Bourg en Bresse
Bourg-en-Bresse
CHU Francois Mitterand
Dijon
CHU Michallon
Grenoble
HCL Croix Rousse
Lyon
HCL Edouard Herriot
Lyon
HCL Lyon Sud
Lyon
CHU Orléans
Orléans, Orléans
CHU La Miletrie
Poitiers
Hopital Nord
Saint-Etienne
About this study
Official title: EXtubation With SUctioning or With Positive End-Expiratory Pressure in Intensive Care Unit: a Multicentre Randomised Controlled Trial.
Extubation in intensive care unit is a risky situation. Its failure is associated with an increase in the duration of mechanical ventilation and high morbidity and mortality.
Our hypothesis is that the extubation procedure associating prior endotracheal aspiration followed by ablation of the intubation probe under the application of a PEEP, would make it possible both to avoid the leakage of secretions towards the lower airways and the alveolar recruitment, compared to extubation with concomitant endotracheal aspiration.
By these mechanisms, this extubation procedure combining prior endotracheal aspiration followed by ablation of the tube under the application of a PEEP, would make it possible to increase the ventilator free days from any mechanical ventilation.
Read the detailed description
Extubation consists of several distinct phases: obtaining the weaning criteria, succeeding weaning test and then removing the intubation tube.
While the first two stages are the subject of numerous publications, the last one is rarely studied. To reduce the risk of failure of extubation, the scientific societies of intensive care medicine have published recommendations. They relate to patient weaning and weaning testing, but there are no clear recommendations for the procedure for removing the intubation tube.
The ablation of the tube, performed by the chest physiotherapist or nurse, typically involves endotracheal aspiration, from deflation of the cuff to removal of the intubation tube.
The objective is theoretically to prevent the secretions accumulated above the cuff, at the pharyngeal level, from falling into the lower airways.
Laboratory data show that inhalation of secretions appears to be greater during ablation of the tube with concomitant endotracheal aspiration, which creates a reverse pressure gradient, propelling the secretions into the lower airways. The application of Positive Expiratory Pressure during the ablation of the tube would help to combat this phenomenon. At the same time, this Positive Expiratory Pressure could have a beneficial effect on alveolar recruitment.
Recent work proves the non-inferiority of the ablation of the tube with the application of a Positive Expiratory Pressure versus the so-called "reference" method, consisting of endotracheal aspiration during the ablation of the tube.
We wish to conduct a comparative, prospective, randomized, multicenter study comparing extubation with concomitant endotracheal aspiration versus ablation of the intubation tube under the application of a PEEP.
- Conditions
- Extubation in Intensive Care Unit
- Being tested
- Extubation with PEEP, Endotracheal Aspiration
- Keywords
- extubation, intensive care, endotracheal aspiration, positive end expiratory pressure, non invasive ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extubation with PEEPProcedure or surgery
No aspiration within the 3 minutes before extubation and extubation with 10cmH2O PEEP
Endotracheal AspirationProcedure or surgery
Aspiration during cuff deflation
| Study group | Role | What they receive |
|---|---|---|
| PEEP Extubation With Positive End-Expiratory Pressure | Experimental | endo-tracheal aspiration followed by the application of PEEP = 10 cm of H2O, maintained for 3 minutes (reventilation and rest time) and continued until the end of the procedure removal of the extubation Receives: Procedure: Extubation with PEEP |
| Aspiration Extubation With SUctioning | Active comparator | endo-tracheal aspiration concomitant with removal of extubation. Suction is maintained throughout the intubation tube ablation procedure Receives: Procedure: Endotracheal Aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator free days at the 28th day
The primary endpoint is the number of mechanical ventilation-free days (invasive and non-invasive) after the first extubation procedure
Measured: From DZéro to D27
Secondary outcomes (6)
Re-intubation rate
The re-intubation rate (%) within seven days following the removal of the Extubation Procedure
Measured: 7 days (from Dzéro to D6)
Cumulated duration of non invasive ventilation (NIV) and High flow oxygenation (HFO)
Duration marked in hours , same for NIV and HFO
Measured: 7 days (from Dzéro to D6)
Proportion of patients with pneumonia and/or atelectasis
radiological assessment of pneumonia and/or atelectasis. A systematic chest radiography is to be done at 72 hours and 7 days after extubation procedure.
Measured: within 72 hours ( D2) and within 7 days ( D6)
Rate of Respiratory acute failure (RAF)
Percentage of included patients who with clinical RAF after extubation procedure
Measured: Within 7 days (from Dzéro to D6)
Lenght of stay in Intensive care unit (ICU) and in hospital
Marked in days.
Measured: within 28 days
Rate of death
Whatever the cause of death for included patients
Measured: Within 28 days (from Dzero to Day 27)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start22 Mar 2023
- Primary completion19 Mar 2025
- Study completion19 Mar 2025
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 Extubation in Intensive Care UnitStudies of the same condition, open and under way.
- 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
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Bourg en Bresse
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins, Hospices Civils de Lyon, the EXSUPEEP study was supported by a grant from the French Ministry of Health (MoH-fr)
- Responsible party
- Sponsor
- Investigators
- Nicholas SEDILLOT, Principal investigator, CH Bourg en Bresse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147636
- Sponsor's protocol ID
- CHB20-001
- Other IDs
- 2022-A00334-39
- Acronym
- EXSUPEEP
- Status last verified
- Nov 2025
- First submitted
- 29 Nov 2021
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sedillot N, Kallel H, Robine A, Pineda JA, Quenot JP, Servant M, Levrat A, Damieux-Verdeau C, Mezidi M, Thibert N, Bohe J, Ballesteros-Calzado A, Stevic N, Mahi L, Sigaud F, Maisonneuve M, Thiery G, Prat P, Thille AW, Haouat S, Plantefeve G, Decullier E, Rabilloud M, Bernon P, Poncelin Y, Bonnici JC. Applying positive end-expiratory pressure before and during endotracheal tube removal versus extubation with concomitant aspiration: protocol for the randomised controlled multicentre EXSUPEEP trial. BMJ Open. 2025 Feb 13;15(2):e092354. doi: 10.1136/bmjopen-2024-092354.
PubMed 39947817
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXtubation With SUctioning or With Positive End-Expiratory Pressure in Intensive Care Unit: a Multicentre Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT05147636
- Acronym / sponsor ID
- EXSUPEEP / CHB20-001
- Conditions
- Extubation in Intensive Care Unit
- Keywords
- extubation, intensive care, endotracheal aspiration, positive end expiratory pressure, non invasive ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- Centre Hospitalier de Bourg en BresseUniversity, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins, Hospices Civils de Lyon, the EXSUPEEP study was supported by a grant from the French Ministry of Health (MoH-fr)
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 19 Mar 2025 (actual)
- First posted
- 7 Dec 2021 (actual)
- 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.
Extubation in intensive care unit is a risky situation. Its failure is associated with an increase in the duration of mechanical ventilation and high morbidity and mortality.
Our hypothesis is that the extubation procedure associating prior endotracheal aspiration followed by ablation of the intubation probe under the application of a PEEP, would make it possible both to avoid the leakage of secretions towards the lower airways and the alveolar recruitment, compared to extubation with concomitant endotracheal aspiration.
By these mechanisms, this extubation procedure combining prior endotracheal aspiration followed by ablation of the tube under the application of a PEEP, would make it possible to increase the ventilator free days from any mechanical ventilation.
Detailed description
Extubation consists of several distinct phases: obtaining the weaning criteria, succeeding weaning test and then removing the intubation tube.
While the first two stages are the subject of numerous publications, the last one is rarely studied. To reduce the risk of failure of extubation, the scientific societies of intensive care medicine have published recommendations. They relate to patient weaning and weaning testing, but there are no clear recommendations for the procedure for removing the intubation tube.
The ablation of the tube, performed by the chest physiotherapist or nurse, typically involves endotracheal aspiration, from deflation of the cuff to removal of the intubation tube.
The objective is theoretically to prevent the secretions accumulated above the cuff, at the pharyngeal level, from falling into the lower airways.
Laboratory data show that inhalation of secretions appears to be greater during ablation of the tube with concomitant endotracheal aspiration, which creates a reverse pressure gradient, propelling the secretions into the lower airways. The application of Positive Expiratory Pressure during the ablation of the tube would help to combat this phenomenon. At the same time, this Positive Expiratory Pressure could have a beneficial effect on alveolar recruitment.
Recent work proves the non-inferiority of the ablation of the tube with the application of a Positive Expiratory Pressure versus the so-called "reference" method, consisting of endotracheal aspiration during the ablation of the tube.
We wish to conduct a comparative, prospective, randomized, multicenter study comparing extubation with concomitant endotracheal aspiration versus ablation of the intubation tube under the application of a PEEP.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEEP Extubation With Positive End-Expiratory Pressure | Experimental | Procedure: Extubation with PEEPendo-tracheal aspiration followed by the application of PEEP = 10 cm of H2O, maintained for 3 minutes (reventilation and rest time) and continued until the end of the procedure removal of the extubation |
| Aspiration Extubation With SUctioning | Active comparator | Procedure: Endotracheal Aspirationendo-tracheal aspiration concomitant with removal of extubation. Suction is maintained throughout the intubation tube ablation procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Firstly, the decision to extubate must be made by the treating clinicians after having validated that the clinical criteria for weaning are met, namely: according to the international conference consensus on weaning , patients will be considered as ready for an initial SBT as soon as they meet all of the following criteria:
- respiratory rate ≤35 breaths per minute,
- adequate oxygenation defined as pulse oximetry (SpO2 ≥90%) with a fraction of inspired oxygen (FiO2) ≤0.4 or PaO2/FiO2 ≥150 mmHg with positive end-expiratory pressure ≤8 cm H2O,
- hemodynamic stability with no need for vasopressors (or doses ≤0.3 μg/kg/min),
- adequate cough,
Key exclusion criteria (11 listed)
- Patients receiving ventilation via tracheostomy.
- Patients with underlying chronic neuromuscular disease
- Patients with severe head injury
- Patients with a decision to withhold and/or withdraw life support
- Patients not affiliated to or beneficiary of any social security scheme.
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 |
|---|---|---|
| Extubation with PEEPNo aspiration within the 3 minutes before extubation and extubation with 10cmH2O PEEP | Procedure or surgery | PEEP Extubation With Positive End-Expiratory Pressure |
| Endotracheal AspirationAspiration during cuff deflation | Procedure or surgery | Aspiration Extubation With SUctioning |
Primary outcome
Ventilator free days at the 28th day
Time frame: From DZéro to D27
The primary endpoint is the number of mechanical ventilation-free days (invasive and non-invasive) after the first extubation procedure
6 secondary outcomes
Re-intubation rate
Time frame: 7 days (from Dzéro to D6)
Cumulated duration of non invasive ventilation (NIV) and High flow oxygenation (HFO)
Time frame: 7 days (from Dzéro to D6)
Proportion of patients with pneumonia and/or atelectasis
Time frame: within 72 hours ( D2) and within 7 days ( D6)
Rate of Respiratory acute failure (RAF)
Time frame: Within 7 days (from Dzéro to D6)
Lenght of stay in Intensive care unit (ICU) and in hospital
Time frame: within 28 days
Rate of death
Time frame: Within 28 days (from Dzero to Day 27)
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 5 Dec 2025.
- Derived from this study: PubMed 39947817Sedillot N, Kallel H, Robine A, Pineda JA, Quenot JP, Servant M, Levrat A, Damieux-Verdeau C, Mezidi M, Thibert N, Bohe J, Ballesteros-Calzado A, Stevic N, Mahi L, Sigaud F, Maisonneuve M, Thiery G, Prat P, Thille AW, Haouat S, Plantefeve G, Decullier E, Rabilloud M, Bernon P, Poncelin Y, Bonnici JC. Applying positive end-expiratory pressure before and during endotracheal tube removal versus extubation with concomitant aspiration: protocol for the randomised controlled multicentre EXSUPEEP trial. BMJ Open. 2025 Feb 13;15(2):e092354. doi: 10.1136/bmjopen-2024-092354.
- Individual participant dataSharing planned: No
Related trials for Extubation in Intensive Care Unit
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Not yet recruitingObservational study
Diaphragm Ultrasound and Rapid Shallow Breathing Index for Predicting Extubation Success
Ventilator Weaning, Respiratory Insufficiency
RecruitingObservational study
EXtubation Related Complications - the EXTUBE Study (EXTUBE)
Extubation
Not yet recruitingObservational study
Predictors of Prolonged Mechanical Ventilation in Preterm Infants
Premature Birth, Respiration Failure
RecruitingObservational study
Rehabilitation Practices in Critically Ill Patients Receiving Invasive Mechanical Ventilation in the Intensive Care Unit.
Mechanical Ventilation, Pulmonary Rehabilitation
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.
Nicholas SEDILLOT principal investigator
CH Bourg en Bresse
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extubation with PEEP and Endotracheal Aspiration in people with Extubation in Intensive Care Unit, run by Centre Hospitalier de Bourg en Bresse at 11 sites 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 12 inclusion and 11 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 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Ventilator free days at the 28th day (time frame: From DZéro to D27). 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 NCT05147636, 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 5 Dec 2025.