Anesthesia, GeneralNCT01323049
Comparison of Spontaneous Ventilation Time in Air Without Desaturation After Positive Pressure Extubation Versus Aspiration Extubation When Awakening From General Anesthesia
A study testing Positive pressure extubation and Aspiration/suction extubation in people with Anesthesia, General, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The primary objective is to show that positive pressure extubation improves oxygenation immediately after extubation compared to extubation via "aspiration" by evaluating and comparing the onset time of desaturation during spontaneous ventilation during awakening following general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- Positive pressure extubation and Aspiration/suction extubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to 25 Feb 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available for 1 hour of follow up
- ASA 1 to 3
- The patient is schedules for orthopedic surgery (limbs) with general anesthesia
Who cannot join
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant
Show all 12Show fewer
- The patient is breastfeeding
- Chronic respiratory insufficiency
- Cardiopathy
- Obstructive sleep apnea
- Two or more predictive criteria for difficult mask ventilation (age > 55 years, toothless, beard, snorer, BMI > 26)
- No predictive criteria for difficult intubation (SPIDS <= 10)
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective is to show that positive pressure extubation improves oxygenation immediately after extubation compared to extubation via "aspiration" by evaluating and comparing the onset time of desaturation during spontaneous ventilation during awakening following general anesthesia.
- Conditions
- Anesthesia, General
- Being tested
- Positive pressure extubation, Aspiration/suction extubation
- Keywords
- extubation strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive pressure extubationProcedure or surgery
Positive pressure extubation will be used for patients waking up from general anesthesia
Aspiration/suction extubationProcedure or surgery
Aspiration/suction extubation will be used for patients waking up from general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Positive pressure extubation | Active comparator | Positive pressure extubation will be used for patients waking up from general anesthesia in this group Receives: Procedure: Positive pressure extubation |
| Aspiration/suction extubation | Active comparator | Aspiration/suction extubation will be used for patients waking up from general anesthesia in this group Receives: Procedure: Aspiration/suction extubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous ventilation (air) time without desaturation after extubation (min)
desaturation is defined as an SpO2< 92%
Measured: 10 minutes
Secondary outcomes (6)
presence/absence of a desaturation after extubation
desaturation is defined as an SpO2<92%
Measured: 10 minutes
minimum Sp02 level after extubation (%)
Measured: 10 minutes
minimum Sp02 level after extubation (%)
Measured: 60 minutes
presence/absence of complications
coughing, airway obstruction, laryngospasm, desaturation, apnea, vomiting in the first hour
Measured: 60 minutes
presence / absence of therapeutic maneuvers
includes oxygen therapy (or bezel ventimasque), Guedel airway, mask assistance, re-intubation during the first hour
Measured: 60 minutes
presence/absence of any complication
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startMar 2012
- Primary completion25 Feb 2014
- Study completion25 Feb 2014
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 Anesthesia, GeneralStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joël L'Hermite, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323049
- Sponsor's protocol ID
- LOCAL/2010/JL-03
- Other IDs
- 2011-A00051-40
- Status last verified
- Mar 2015
- First submitted
- 24 Mar 2011
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
L'Hermite J, Wira O, Castelli C, de La Coussaye JE, Ripart J, Cuvillon P. Tracheal extubation with suction vs. positive pressure during emergence from general anaesthesia in adults: A randomised controlled trial. Anaesth Crit Care Pain Med. 2018 Apr;37(2):147-153. doi: 10.1016/j.accpm.2017.07.005. Epub 2017 Sep 4.
PubMed 28882741
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Spontaneous Ventilation Time in Air Without Desaturation After Positive Pressure Extubation Versus Aspiration Extubation When Awakening From General Anesthesia
- ClinicalTrials.gov ID
- NCT01323049
- Acronym / sponsor ID
- LOCAL/2010/JL-03
- Conditions
- Anesthesia, General
- Keywords
- extubation strategy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- 25 Feb 2014 (actual)
- Study completion
- 25 Feb 2014 (actual)
- First posted
- 25 Mar 2011 (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 primary objective is to show that positive pressure extubation improves oxygenation immediately after extubation compared to extubation via "aspiration" by evaluating and comparing the onset time of desaturation during spontaneous ventilation during awakening following general anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive pressure extubation | Active comparator | Procedure: Positive pressure extubationPositive pressure extubation will be used for patients waking up from general anesthesia in this group |
| Aspiration/suction extubation | Active comparator | Procedure: Aspiration/suction extubationAspiration/suction extubation will be used for patients waking up from general anesthesia in this group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available for 1 hour of follow up
- ASA 1 to 3
- The patient is schedules for orthopedic surgery (limbs) with general anesthesia
Key exclusion criteria (12 listed)
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
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 |
|---|---|---|
| Positive pressure extubationPositive pressure extubation will be used for patients waking up from general anesthesia | Procedure or surgery | Positive pressure extubation |
| Aspiration/suction extubationAspiration/suction extubation will be used for patients waking up from general anesthesia | Procedure or surgery | Aspiration/suction extubation |
Primary outcome
Spontaneous ventilation (air) time without desaturation after extubation (min)
Time frame: 10 minutes
desaturation is defined as an SpO2< 92%
6 secondary outcomes
presence/absence of a desaturation after extubation
Time frame: 10 minutes
minimum Sp02 level after extubation (%)
Time frame: 10 minutes
minimum Sp02 level after extubation (%)
Time frame: 60 minutes
presence/absence of complications
Time frame: 60 minutes
presence / absence of therapeutic maneuvers
Time frame: 60 minutes
presence/absence of any complication
Time frame: 60 minutes
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 17 Nov 2025.
- Results publication: PubMed 28882741L'Hermite J, Wira O, Castelli C, de La Coussaye JE, Ripart J, Cuvillon P. Tracheal extubation with suction vs. positive pressure during emergence from general anaesthesia in adults: A randomised controlled trial. Anaesth Crit Care Pain Med. 2018 Apr;37(2):147-153. doi: 10.1016/j.accpm.2017.07.005. Epub 2017 Sep 4.
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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.
Joël L'Hermite, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive pressure extubation and Aspiration/suction extubation in people with Anesthesia, General, run by Centre Hospitalier Universitaire de Nīmes 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 5 inclusion and 12 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 17 Nov 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?
Spontaneous ventilation (air) time without desaturation after extubation (min) (time frame: 10 minutes). 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 NCT01323049, 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 17 Nov 2025.