Mechanical Ventilation With Oral IntubationINTENTIONNCT07130123
Endotracheal Suctionning During Positive Pressure Extubation in ICU
A study testing Suctionning extubation and No suctionning Extubation in people with Mechanical Ventilation With Oral Intubation and Weaning Invasive Mechanical Ventilation, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
The aim of this clinical trial is to evaluate endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients (over 18 years old) in the intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation With Oral Intubation, Weaning Invasive Mechanical Ventilation, Oxygen Saturation Measurement
- What is being tested?
- Suctionning extubation and No suctionning Extubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult patient
- Intubated for more than 48 hours
- Patient for whom extubation is prescribed by the patient's physician
Who cannot join
- Headboard restriction>30°.
- Decision to limit active treatment in advance of reintubation
- Protected person (under guardianship or curatorship)
- Person under court protection
- Persons deprived of liberty
- Persons not affiliated to a social security scheme
- Pregnant or breast-feeding woman
- No co-inclusion with a study whose period of interest is follow-up within 3 hours of extubation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire d'Orléans
Orléans, Loiret, 45067
Cécile FOSSAT, +33238575252, cecile.fossat@chu-orleans.fr
About this study
Official title: Removal of the Intubation Tube Under Positive Pressure With or Without Endotracheal Suctioning During Extubation in Intensive Care: a Prospective Randomised Controlled Trial
The aim of this clinical trial is to evaluate endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients (over 18 years old) in the intensive care unit (ICU). The main question it aims to answer is whether the intervention improves the respiratory oxygenation index (ROX) three hours after extubation compared to no endotracheal suction during positive pressure extubation.
Participants will only need to be extubated by the nursing team in the ICU. Follow-up will consist of evaluating respiratory rate, pulse oximetry and inspired oxygen fraction for three hours following extubation.
Read the detailed description
This is a prospective, randomised, controlled trial. The aim of this study is to evaluate endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients (over 18 years old) in the intensive care unit (ICU). The main question it aims to answer is whether the intervention improves the respiratory oxygenation index (ROX) three hours after extubation compared to no endotracheal suction during positive pressure extubation.
Inclusion : Participants who meet eligibility criteria will be randomized into experimental arm (endotracheal suctioning during positive pressure extubation) or control arm (no endotracheal suction during positive pressure extubation).
Intervention and Follow-up : participants will only need to be extubated by the nursing team in the ICU. Follow-up will consist of evaluating respiratory rate, pulse oximetry and inspired oxygen fraction for three hours following extubation.
End of study : at the end of the study visit (28 days after extubation), vital status of participants will be recorded.
- Conditions
- Mechanical Ventilation With Oral Intubation, Weaning Invasive Mechanical Ventilation, Oxygen Saturation Measurement, Rox Index, Extubation
- Being tested
- Suctionning extubation, No suctionning Extubation
- Keywords
- rox index, extubation, Suctionning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suctionning extubationProcedure or surgery
We will remove the intubation tube with endotracheal suctioning during the extubation procedure and maintain positive end expiratory pressure (PEEP) and pressure support. The PEEP level will be 10 cmH2O and the pressure support 7 cmH2O for 2 minutes prior to extubation. The vacuum level will be the maximum level (standard procedure in the unit), i.e. 450 mmHg. The closed-system suction probe is inserted up to the last mark corresponding to 40cm. The size of our closed system is identical for all patients, i.e. 14 french.
No suctionning ExtubationProcedure or surgery
In the control group, removal of the intubation tube during the extubation procedure is performed with PEEP maintained, without endotracheal suctioning. The PEEP level will be set at 10 cmH2O and the pressure at 7 cmH2O in the 2 minutes prior to extubation.
| Study group | Role | What they receive |
|---|---|---|
| Suctionning Extubation (experimental arm) | Experimental | Endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients in the intensive care unit. Receives: Procedure: Suctionning extubation |
| No Suctionning Extubation (control arm) | Sham comparator | No endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients in the intensive care unit. Receives: Procedure: No suctionning Extubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratoy/oxygenation index (ROX index)
Rox index will be assessed 3 hours after extubation by an investigator with no information about randomization (blind assessment)
Measured: 3 hours after extubation
Secondary outcomes (4)
Mechanical ventilation weaning failure
Weaning failure corresponds with death or new intabution
Measured: During 7 days after extubation
ROX index evolution
Rox index will be assessed 3 times after extubation in order to evaluate its evolution (blind assessment) :
- 30 minutes after extubation
- 1 hour after extubation
- 3 hour after extubation
Measured: During 3 hours after extubation
Pneumonia after extubation
Rate of hospital-acquired pneumonia confirmed by an investigator
Measured: During 7 days after extubation
Airway clearance technique
Use of any airway clearance technique after extubation :
- nasotracheal suction
- respiratory physiotherapy
- bronchial fibroscopy
Measured: During 24 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start3 Oct 2025
- Primary completionSep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation With Oral IntubationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile FOSSAT, Principal investigator, Centre Hospitalier Universitaire d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130123
- Sponsor's protocol ID
- CHUO-2025-12
- Acronym
- INTENTION
- Status last verified
- Dec 2025
- First submitted
- 12 Aug 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med. 2002 Apr 1;165(7):867-903. doi: 10.1164/ajrccm.165.7.2105078.
PubMed 11934711Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.
PubMed 18367735Boles 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 17470624Frutos-Vivar F, Esteban A, Apezteguia C, Gonzalez M, Arabi Y, Restrepo MI, Gordo F, Santos C, Alhashemi JA, Perez F, Penuelas O, Anzueto A. Outcome of reintubated patients after scheduled extubation. J Crit Care. 2011 Oct;26(5):502-509. doi: 10.1016/j.jcrc.2010.12.015. Epub 2011 Mar 3.
PubMed 21376523Fossat G, Desmalles E, Courtes L, Fossat C, Boulain T. Cough Peak Flow Assessment Without Disconnection From the ICU Ventilator in Mechanically Ventilated Patients. Respir Care. 2023 Apr;68(4):470-477. doi: 10.4187/respcare.10412. Epub 2023 Mar 6.
PubMed 36878644
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Removal of the Intubation Tube Under Positive Pressure With or Without Endotracheal Suctioning During Extubation in Intensive Care: a Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07130123
- Acronym / sponsor ID
- INTENTION / CHUO-2025-12
- Conditions
- Mechanical Ventilation With Oral Intubation, Weaning Invasive Mechanical Ventilation, Oxygen Saturation Measurement, Rox Index, Extubation
- Keywords
- rox index, extubation, Suctionning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 19 Aug 2025 (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.
The aim of this clinical trial is to evaluate endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients (over 18 years old) in the intensive care unit (ICU). The main question it aims to answer is whether the intervention improves the respiratory oxygenation index (ROX) three hours after extubation compared to no endotracheal suction during positive pressure extubation.
Participants will only need to be extubated by the nursing team in the ICU. Follow-up will consist of evaluating respiratory rate, pulse oximetry and inspired oxygen fraction for three hours following extubation.
Detailed description
This is a prospective, randomised, controlled trial. The aim of this study is to evaluate endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients (over 18 years old) in the intensive care unit (ICU). The main question it aims to answer is whether the intervention improves the respiratory oxygenation index (ROX) three hours after extubation compared to no endotracheal suction during positive pressure extubation.
Inclusion : Participants who meet eligibility criteria will be randomized into experimental arm (endotracheal suctioning during positive pressure extubation) or control arm (no endotracheal suction during positive pressure extubation).
Intervention and Follow-up : participants will only need to be extubated by the nursing team in the ICU. Follow-up will consist of evaluating respiratory rate, pulse oximetry and inspired oxygen fraction for three hours following extubation.
End of study : at the end of the study visit (28 days after extubation), vital status of participants will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suctionning Extubation (experimental arm) | Experimental | Procedure: Suctionning extubationEndotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients in the intensive care unit. |
| No Suctionning Extubation (control arm) | Sham comparator | Procedure: No suctionning ExtubationNo endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients in the intensive care unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patient
- Intubated for more than 48 hours
- Patient for whom extubation is prescribed by the patient's physician
Key exclusion criteria (8 listed)
- Headboard restriction>30°.
- Decision to limit active treatment in advance of reintubation
- Protected person (under guardianship or curatorship)
- Person under court protection
- Persons deprived of liberty
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 |
|---|---|---|
| Suctionning extubationWe will remove the intubation tube with endotracheal suctioning during the extubation procedure and maintain positive end expiratory pressure (PEEP) and pressure support. The PEEP level will be 10 cmH2O and the pressure support 7 cmH2O for 2 minutes prior to extubation. The vacuum level will be the maximum level (standard procedure in the unit), i.e. 450 mmHg. The closed-system suction probe is inserted up to the last mark corresponding to 40cm. The size of our closed system is identical for all patients, i.e. 14 french. | Procedure or surgery | Suctionning Extubation (experimental arm) |
| No suctionning ExtubationIn the control group, removal of the intubation tube during the extubation procedure is performed with PEEP maintained, without endotracheal suctioning. The PEEP level will be set at 10 cmH2O and the pressure at 7 cmH2O in the 2 minutes prior to extubation. | Procedure or surgery | No Suctionning Extubation (control arm) |
Primary outcome
Respiratoy/oxygenation index (ROX index)
Time frame: 3 hours after extubation
Rox index will be assessed 3 hours after extubation by an investigator with no information about randomization (blind assessment)
4 secondary outcomes
Mechanical ventilation weaning failure
Time frame: During 7 days after extubation
ROX index evolution
Time frame: During 3 hours after extubation
Pneumonia after extubation
Time frame: During 7 days after extubation
Airway clearance technique
Time frame: During 24 hours after extubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Background: PubMed 11934711Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med. 2002 Apr 1;165(7):867-903. doi: 10.1164/ajrccm.165.7.2105078.
- Background: PubMed 18367735Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.
- 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 21376523Frutos-Vivar F, Esteban A, Apezteguia C, Gonzalez M, Arabi Y, Restrepo MI, Gordo F, Santos C, Alhashemi JA, Perez F, Penuelas O, Anzueto A. Outcome of reintubated patients after scheduled extubation. J Crit Care. 2011 Oct;26(5):502-509. doi: 10.1016/j.jcrc.2010.12.015. Epub 2011 Mar 3.
- Background: PubMed 36878644Fossat G, Desmalles E, Courtes L, Fossat C, Boulain T. Cough Peak Flow Assessment Without Disconnection From the ICU Ventilator in Mechanically Ventilated Patients. Respir Care. 2023 Apr;68(4):470-477. doi: 10.4187/respcare.10412. Epub 2023 Mar 6.
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.
Cécile FOSSAT principal investigator
Centre Hospitalier Universitaire d'Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suctionning extubation and No suctionning Extubation in people with Mechanical Ventilation With Oral Intubation and Weaning Invasive Mechanical Ventilation, run by Centre Hospitalier Régional d'Orléans 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 8 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: looking for participants now, as of the sponsor's last update on 19 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 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cécile FOSSAT (+33238575252, fanny.louat@chu-orleans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratoy/oxygenation index (ROX index) (time frame: 3 hours 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 NCT07130123, which also lists 5 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 Dec 2025.