AnesthesiaExtub_LocaNCT06249659
Impact of Extubation Location After Surgery on Perioperative Times
An observational study of Anesthesia and Intubation, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The additional time required to awaken a patient is one of the main reasons for not extubating him or her in the operating room (OR). Conversely, transferring an intubated patient to recovery room (RR), prolonging the duration of anesthesia and intubation, in a limited environment in human resources, may lead to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Intubation, Surgery
- What is being tested?
- Extubation in operative room and Extubation in post anesthesia care unit
- Type of treatment
- Surgery or procedure
- How many people
- 756 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2020to 1 Feb 2023
- Phase
- Observational
- 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
Study population: Any patient requiring endotracheal extubation after general anesthesia
Who may be able to join
- Adult (older than 18 years old)
- Patients admitted to any operative room of participating centre for a surgical or endoscopic procedure under general anaesthesia requiring endo-tracheal intubation
- Subjects must be covered by public health insurance
- Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.
Who cannot join
- Patient extubated in intensive care unit
- Patient extubated during on-call hours (because of a reduced number of medical and paramedical staff)
- Patient extubated following cardiac surgery
- Refusal of study participation or to pursue the study by the patient
- Absence of coverage by the French statutory healthcare insurance system
- Protected person
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Extubation Location After Surgery on Perioperative Times. A Prospective Multicenter Observational Study. Extub_Loca Study
The additional time required to awaken a patient is one of the main reasons for not extubating him or her in the operating room (OR). Conversely, transferring an intubated patient to recovery room (RR), prolonging the duration of anesthesia and intubation, in a limited environment in human resources, may lead to increased complications' rates. Little is known about those time lengths and complications rates.
Read the detailed description
The additional time required to awaken a patient is one of the main reasons for not extubating him or her in the operating room (OR). Conversely, transferring an intubated patient to recovery room (RR), prolonging the duration of anesthesia and intubation, in a limited environment in human resources, may lead to increased complications' rates. Little is known about those time lengths and complications rates. The primary objective was to evaluate the additional OR occupancy time associated with awakening and extubation. Secondary objectives were to assess the rate of post-extubation complications and the need for ventilatory support. This was a prospective multicenter observational study involving intubated patients who underwent surgeries in the operating theatres of the Montpellier and Clermont-Ferrand university hospitals. Anesthesia teams were asked to complete a form including data related to the patient, surgical procedure, anesthesia procedure (induction and recovery) and the occurrence of any complications during the procedure. A multivariate analysis was conducted on the full cohort, using a propensity score (IPTW, inverse probability of treatment weighting) to account for imbalances between groups.
- Conditions
- Anesthesia, Intubation, Surgery, Extubation, Respiratory Failure, Complication,Postoperative
- Being tested
- Extubation in operative room, Extubation in post anesthesia care unit
- Keywords
- General anesthesia, Extubation, Intubation, Time, Complications
- Medical subject headings
- Respiratory Insufficiency, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extubation in operative roomProcedure or surgery
Extubation takes place in operative room
Extubation in post anesthesia care unitProcedure or surgery
Extubation takes place in post anesthesia care unit
| Study group | Role | What they receive |
|---|---|---|
| Extubation in operative room | Patients are extubated in operative room after the end of surgery Receives: Procedure: Extubation in operative room | |
| Extubation in post anesthesia care unit | Patients are extubated in post anesthesia care unit, after transfer from operative room Receives: Procedure: Extubation in post anesthesia care unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Additional operative room occupancy time associated with awakening and extubation
Time between dressing application (or end of procedure if there was no cutaneous effraction) and discharge from the OR
Measured: From end of procedure until extubation, assessed up to 2 hours
Secondary outcomes (17)
Time from the end of the surgical procedure (closure of surgical site and dressing placement) to extubation
Time from the end of the surgical procedure (closure of surgical site and dressing placement) to extubation
Measured: From end of procedure until extubation, assessed up to 2 hours
Time from the end of anaesthesia drug administration to extubation
Time from the end of anaesthesia drug administration to extubation
Measured: From end of anesthesia drug administration until extubation, assessed up to 2 hours
Time from the end of the surgical procedure to patient able to be transferred to the ward (as defined by an Aldrete score above 10)
Time from the end of the surgical procedure to patient able to be transferred to the ward (as defined by an Aldrete score above or equal to 10). Aldrete's scoring system is a commonly used scale for determining when postsurgical patients can be safely discharged from the post-anesthesia care unit (PACU), generally to an hospital ward, or home. Modified Aldrete score ranges from 0 to 12.
Measured: From end of procedure until discharge to surgical ward, assessed up to 6 hours
Impact of sequencing of operating programme in the room concerned on extubation location
Impact of sequencing of operating programme in the room concerned on extubation location
Measured: From end of procedure until next procedure in the same room, assessed up to one day
Incidence of oxygen support requirement_Day-1
Oxygen support requirement on the first day post-extubation
Measured: First postoperative day
Reported post-operative pulmonary complications_Day7
Reported post-operative pulmonary complications within the first 7 days after extubation (as defined as acute respiratory failure, atelectasis, pneumonia, bronchospasm, pulmonary embolism or cardiorespiratory arrest)
Measured: Seven first postoperative days
Oxygen therapy_PACU
Use of any rescue oxygen therapy after extubation in post-anesthesia care unit
Measured: From end of procedure until discharge to surgical ward, assessed up to 6 hours
Hypotension_PACU
Hypotension occurrence (as defined by a systolic blood pressure below 90 mmHg and/or a mean arterial pressure below 65 mmHg)
Measured: From end of procedure until discharge to surgical ward, assessed up to 6 hours
Bradycardia_PACU
Bradycardia occurrence (as defined as a drop of cardiac frequency below 50 beats.min-1)
Measured: From end of procedure until discharge to surgical ward, assessed up to 6 hours
Hypoxemia_PACU
Desaturation occurrence defined as a drop of SpO2 below 96% (15), either early (within 5 min post-extubation) or delayed
Measured: From end of procedure until discharge to surgical ward, assessed up to 6 hours
NMBA_PACU
Presence of residual neuromuscular blockade as illustrated by train of four below 90%
Measured: From end of procedure until discharge to surgical ward, assessed up to 6 hours
Reversal_NMBA
Incidence of pharmacologic reversal of neuromuscular blocking agents
Measured: From end of anesthesia until extubation, assessed up to 2 hours
Loco-regional anaesthetic technique
Use of any loco-regional anaesthetic technique
Measured: Perioperative
Drugs_neuromuscular blocking agents
Use of neuromuscular blocking agents during anesthesia
Measured: Perioperative
Drugs_opioids
Use of opioids during anesthesia
Measured: Perioperative
Drugs_hypnotics
Use of hypnotics during anesthesia
Measured: Perioperative
Drugs_adjuvant analgesics
Use of adjuvant analgesics during anesthesia
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Sep 2020
- Primary completion28 Jan 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 756 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Montpellier
- Responsible party
- Sponsor
- Investigators
- Thomas Godet, MD, PhD, Principal investigator, Clermont-Ferrand University HospitalsAudrey De Jong, MD, PhD, Principal investigator, Montpellier University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249659
- Sponsor's protocol ID
- IRB-MTP_2022_04_202201100
- Acronym
- Extub_Loca
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Available upon reasonable request after evaluation of research question
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Extubation Location After Surgery on Perioperative Times. A Prospective Multicenter Observational Study. Extub_Loca Study
- ClinicalTrials.gov ID
- NCT06249659
- Acronym / sponsor ID
- Extub_Loca / IRB-MTP_2022_04_202201100
- Conditions
- Anesthesia, Intubation, Surgery, Extubation, Respiratory Failure, Complication,Postoperative
- Keywords
- General anesthesia, Extubation, Intubation, Time, Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 756 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- University Hospital, Montpellier
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 28 Jan 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 8 Feb 2024 (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 additional time required to awaken a patient is one of the main reasons for not extubating him or her in the operating room (OR). Conversely, transferring an intubated patient to recovery room (RR), prolonging the duration of anesthesia and intubation, in a limited environment in human resources, may lead to increased complications' rates. Little is known about those time lengths and complications rates.
Detailed description
The additional time required to awaken a patient is one of the main reasons for not extubating him or her in the operating room (OR). Conversely, transferring an intubated patient to recovery room (RR), prolonging the duration of anesthesia and intubation, in a limited environment in human resources, may lead to increased complications' rates. Little is known about those time lengths and complications rates. The primary objective was to evaluate the additional OR occupancy time associated with awakening and extubation. Secondary objectives were to assess the rate of post-extubation complications and the need for ventilatory support. This was a prospective multicenter observational study involving intubated patients who underwent surgeries in the operating theatres of the Montpellier and Clermont-Ferrand university hospitals. Anesthesia teams were asked to complete a form including data related to the patient, surgical procedure, anesthesia procedure (induction and recovery) and the occurrence of any complications during the procedure. A multivariate analysis was conducted on the full cohort, using a propensity score (IPTW, inverse probability of treatment weighting) to account for imbalances between groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extubation in operative room | – | Procedure: Extubation in operative roomPatients are extubated in operative room after the end of surgery |
| Extubation in post anesthesia care unit | – | Procedure: Extubation in post anesthesia care unitPatients are extubated in post anesthesia care unit, after transfer from operative room |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient requiring endotracheal extubation after general anesthesia
Key inclusion criteria (4 listed)
- Adult (older than 18 years old)
- Patients admitted to any operative room of participating centre for a surgical or endoscopic procedure under general anaesthesia requiring endo-tracheal intubation
- Subjects must be covered by public health insurance
- Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.
Key exclusion criteria (6 listed)
- Patient extubated in intensive care unit
- Patient extubated during on-call hours (because of a reduced number of medical and paramedical staff)
- Patient extubated following cardiac surgery
- Refusal of study participation or to pursue the study by the patient
- Absence of coverage by the French statutory healthcare insurance system
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 in operative roomExtubation takes place in operative room | Procedure or surgery | Extubation in operative room |
| Extubation in post anesthesia care unitExtubation takes place in post anesthesia care unit | Procedure or surgery | Extubation in post anesthesia care unit |
Primary outcome
Additional operative room occupancy time associated with awakening and extubation
Time frame: From end of procedure until extubation, assessed up to 2 hours
Time between dressing application (or end of procedure if there was no cutaneous effraction) and discharge from the OR
17 secondary outcomes
Time from the end of the surgical procedure (closure of surgical site and dressing placement) to extubation
Time frame: From end of procedure until extubation, assessed up to 2 hours
Time from the end of anaesthesia drug administration to extubation
Time frame: From end of anesthesia drug administration until extubation, assessed up to 2 hours
Time from the end of the surgical procedure to patient able to be transferred to the ward (as defined by an Aldrete score above 10)
Time frame: From end of procedure until discharge to surgical ward, assessed up to 6 hours
Impact of sequencing of operating programme in the room concerned on extubation location
Time frame: From end of procedure until next procedure in the same room, assessed up to one day
Incidence of oxygen support requirement_Day-1
Time frame: First postoperative day
Reported post-operative pulmonary complications_Day7
Time frame: Seven first postoperative days
Oxygen therapy_PACU
Time frame: From end of procedure until discharge to surgical ward, assessed up to 6 hours
Hypotension_PACU
Time frame: From end of procedure until discharge to surgical ward, assessed up to 6 hours
Bradycardia_PACU
Time frame: From end of procedure until discharge to surgical ward, assessed up to 6 hours
Hypoxemia_PACU
Time frame: From end of procedure until discharge to surgical ward, assessed up to 6 hours
NMBA_PACU
Time frame: From end of procedure until discharge to surgical ward, assessed up to 6 hours
Reversal_NMBA
Time frame: From end of anesthesia until extubation, assessed up to 2 hours
Loco-regional anaesthetic technique
Time frame: Perioperative
Drugs_neuromuscular blocking agents
Time frame: Perioperative
Drugs_opioids
Time frame: Perioperative
Drugs_hypnotics
Time frame: Perioperative
Drugs_adjuvant analgesics
Time frame: Perioperative
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 8 Feb 2024.
- Individual participant dataSharing planned: Undecided. Available upon reasonable request after evaluation of research question
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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.
Thomas Godet, MD, PhD principal investigator
Clermont-Ferrand University Hospitals
Audrey De Jong, MD, PhD principal investigator
Montpellier University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Intubation, run by University Hospital, Clermont-Ferrand 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 4 inclusion and 6 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 8 Feb 2024. 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?
Additional operative room occupancy time associated with awakening and extubation (time frame: From end of procedure until extubation, assessed up to 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2024.