AnesthesiaNCT04993001
Impact of an Open Lung Extubation Strategy on Postoperative Pulmonary Complications
A study testing Open lung extubation and Conventional extubation in people with Anesthesia and Pulmonary Atelectasis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Perioperative respiratory complications are a major source of morbidity and mortality. Postoperative atelectasis plays a central role in their development. Protective "open lung" mechanical ventilation aims to minimize the occurrence of atelectasis during the perioperative period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Pulmonary Atelectasis, Complication of Anesthesia
- What is being tested?
- Open lung extubation and Conventional extubation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteCanada
- Study dates
- 3 Nov 2021to 17 Jan 2022
- 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
- Patients over 18 years of age requiring elective surgery under general anesthesia and hospitalization.
- Patients with a moderate or high risk of postoperative pulmonary complication according to the ARISCAT score (score of 26 or more)
Who cannot join
- Expected or known difficult intubation according to the treating anesthesiologist
- Postoperative mechanical ventilation (planned or unplanned)
- Neuromuscular disease
- Intrathoracic surgery
- Respiratory failure, sepsis or mechanical ventilation in the month preceding anesthesia
- Pregnancy
Show all 11Show fewer
- Patient refusal
- Ultrasound sub-study:
- Body mass index greater than 40 kg.m-2
- Extensive postoperative chest dressings
- Clinician's refusal to participate
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
About this study
Official title: Impact of an Open Lung Extubation Strategy on Postoperative Pulmonary Complications Compared to a Conventional Extubation Strategy: a Pilot Study
Perioperative respiratory complications are a major source of morbidity and mortality. Postoperative atelectasis plays a central role in their development. Protective "open lung" mechanical ventilation aims to minimize the occurrence of atelectasis during the perioperative period. Randomized controlled studies have been performed comparing various "open lung" ventilation protocols, but these studies report varying and conflicting effects. The interpretation of these studies is complicated by the absence of imagery supporting the pulmonary impact associated with the use of different ventilation strategies. Imaging studies suggest that the gain in pulmonary gas content in "open lung" ventilation regimens disappears within minutes after the extubation. Thus, the potential benefits of open-lung ventilation appear to be lost if, at the time of extubation, no measures are used to keep the lungs well aerated. Recent expert recommendations on good mechanical ventilation practices in the operating room conclude that there is actually no quality study on extubation.
Extubation is a very common practice for anesthesiologists as part of their daily clinical practice. It is therefore imperative to generate evidence on good clinical practice during anesthetic emergence in order to potentially identify an effective extubation strategy to reduce postoperative pulmonary complications.
Read the detailed description
The aim of this study is to establish the feasibility of a multicenter randomized controlled clinical trial comparing two clinical strategies called "open lung" and "conventional" during extubation. The investigators also aim to estimate the rates of postoperative pulmonary complications in the two intervention groups and verify the hypothesis that the "open lung" extubation strategy improves postoperative lung aeration as measured by the quantitative Lung Ultrasound Score compared to a conventional extubation strategy.
Methods
A pilot, prospective, randomized and controlled triple-blind study. Sixty-nine patients scheduled to undergo elective surgery at the CHUM and at moderate or high risk of postoperative pulmonary complications according to the ARISCAT score will be recruited. Following the administration of standardized mechanical ventilation and after obtaining consent, participants will be randomly assigned to two groups: Intervention group, "open lung" extubation strategy and Control group, "conventional" extubation strategy.
- Being tested
- Open lung extubation, Conventional extubation
- Keywords
- Open lung extubation strategy, Postoperative pulmonary complications
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open lung extubationOther
Before starting emergence from anesthesia, the patient will be transferred to their hospital bed or stretcher and seated at 30 degrees. Secretions from the patients' oropharynx will be suctioned. To prevent the patient from coughing, the anesthetic gas or intravenous agent will be stopped after the transfer and suction procedure are completed. The FiO2 will be maintained at the same level or increased to 50% (minimum FiO2) with a fresh gas flow rate greater than or equal to 10 L.min-1. The ventilation mode will be changed to pressure support. The level of pressure support will be modified by the anesthesiologist to generate the same volumes as with controlled ventilation. The PEEP will be maintained at the same level. The minimum respiratory rate will be reduced by 4 min-1. The inspiratory flow for triggering will be 2 L.min-1.
Conventional extubationOther
Before starting emergence from anesthesia, the patient will be transferred to his hospital bed or stretcher and kept in the supine position. Secretions from the patients' oropharynx will be suctioned. To prevent the patient from coughing, the anesthetic gas or intravenous agent will be stopped after the transfer and suction procedure are completed. The FiO2 will be increased to 100% with a fresh gas flow rate greater than or equal to 10 L.min-1. The ventilator will be stopped with the APL valve open to atmosphere. The patient will be manually ventilated with the reservoir bag until spontaneous ventilation resumes. Then, the patient may be manually assisted if the treating anesthesiologist deems it necessary.
| Study group | Role | What they receive |
|---|---|---|
| Emergence from general anesthesia with an open lung extubation strategy | Active comparator | Not described Receives: Other: Open lung extubation |
| Emergence from general anesthesia with a conventional extubation strategy | Placebo comparator | Not described Receives: Other: Conventional extubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protocol adherence rate
During emergence from general anesthesia, a research assistant will observe the adherence to the protocol. The adherence rate will be defined as the number of extubations performed according to the protocol and the patient assigned group divided by the total number of awakenings. In the event of a breach of the protocol, the specific elements that led to the deviation will be noted as well as the reasons given by the treating anesthesiologist to justify it.
Measured: At the end of the surgery
Secondary outcomes (3)
Number of eligible patients per week
Measured: Through study completion, an average of 1 year
Rate of consent to participate in the protocol
Measured: Through study completion, an average of 1 year
Rate of missing values
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start3 Nov 2021
- Primary completion17 Dec 2021
- Study completion17 Jan 2022
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 AnesthesiaStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Model description
- Pilot, single-center, randomized, triple-blind controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Girard, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993001
- Sponsor's protocol ID
- 21.126
- Status last verified
- May 2022
- First submitted
- 26 Jul 2021
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Girard J, Zaouter C, Moore A, Carrier FM, Girard M. Effects of an open lung extubation strategy compared with a conventional extubation strategy on postoperative pulmonary complications after general anesthesia: a single-centre pilot randomized controlled trial. Can J Anaesth. 2023 Oct;70(10):1648-1659. doi: 10.1007/s12630-023-02533-z. Epub 2023 Jul 27.
PubMed 37498442
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Open Lung Extubation Strategy on Postoperative Pulmonary Complications Compared to a Conventional Extubation Strategy: a Pilot Study
- ClinicalTrials.gov ID
- NCT04993001
- Acronym / sponsor ID
- 21.126
- Keywords
- Open lung extubation strategy, Postoperative pulmonary complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 17 Jan 2022 (actual)
- First posted
- 6 Aug 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.
Perioperative respiratory complications are a major source of morbidity and mortality. Postoperative atelectasis plays a central role in their development. Protective "open lung" mechanical ventilation aims to minimize the occurrence of atelectasis during the perioperative period. Randomized controlled studies have been performed comparing various "open lung" ventilation protocols, but these studies report varying and conflicting effects. The interpretation of these studies is complicated by the absence of imagery supporting the pulmonary impact associated with the use of different ventilation strategies. Imaging studies suggest that the gain in pulmonary gas content in "open lung" ventilation regimens disappears within minutes after the extubation. Thus, the potential benefits of open-lung ventilation appear to be lost if, at the time of extubation, no measures are used to keep the lungs well aerated. Recent expert recommendations on good mechanical ventilation practices in the operating room conclude that there is actually no quality study on extubation.
Extubation is a very common practice for anesthesiologists as part of their daily clinical practice. It is therefore imperative to generate evidence on good clinical practice during anesthetic emergence in order to potentially identify an effective extubation strategy to reduce postoperative pulmonary complications.
Detailed description
The aim of this study is to establish the feasibility of a multicenter randomized controlled clinical trial comparing two clinical strategies called "open lung" and "conventional" during extubation. The investigators also aim to estimate the rates of postoperative pulmonary complications in the two intervention groups and verify the hypothesis that the "open lung" extubation strategy improves postoperative lung aeration as measured by the quantitative Lung Ultrasound Score compared to a conventional extubation strategy.
Methods
A pilot, prospective, randomized and controlled triple-blind study. Sixty-nine patients scheduled to undergo elective surgery at the CHUM and at moderate or high risk of postoperative pulmonary complications according to the ARISCAT score will be recruited. Following the administration of standardized mechanical ventilation and after obtaining consent, participants will be randomly assigned to two groups: Intervention group, "open lung" extubation strategy and Control group, "conventional" extubation strategy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot, single-center, randomized, triple-blind controlled study
| Arm | Type | Receives |
|---|---|---|
| Emergence from general anesthesia with an open lung extubation strategy | Active comparator | Other: Open lung extubation |
| Emergence from general anesthesia with a conventional extubation strategy | Placebo comparator | Other: Conventional extubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 18 years of age requiring elective surgery under general anesthesia and hospitalization.
- Patients with a moderate or high risk of postoperative pulmonary complication according to the ARISCAT score (score of 26 or more)
Key exclusion criteria (11 listed)
- Expected or known difficult intubation according to the treating anesthesiologist
- Postoperative mechanical ventilation (planned or unplanned)
- Neuromuscular disease
- Intrathoracic surgery
- Respiratory failure, sepsis or mechanical ventilation in the month preceding anesthesia
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 |
|---|---|---|
| Open lung extubationBefore starting emergence from anesthesia, the patient will be transferred to their hospital bed or stretcher and seated at 30 degrees. Secretions from the patients' oropharynx will be suctioned. To prevent the patient from coughing, the anesthetic gas or intravenous agent will be stopped after the transfer and suction procedure are completed. The FiO2 will be maintained at the same level or increased to 50% (minimum FiO2) with a fresh gas flow rate greater than or equal to 10 L.min-1. The ventilation mode will be changed to pressure support. The level of pressure support will be modified by the anesthesiologist to generate the same volumes as with controlled ventilation. The PEEP will be maintained at the same level. The minimum respiratory rate will be reduced by 4 min-1. The inspiratory flow for triggering will be 2 L.min-1. | Other | Emergence from general anesthesia with an open lung extubation strategy |
| Conventional extubationBefore starting emergence from anesthesia, the patient will be transferred to his hospital bed or stretcher and kept in the supine position. Secretions from the patients' oropharynx will be suctioned. To prevent the patient from coughing, the anesthetic gas or intravenous agent will be stopped after the transfer and suction procedure are completed. The FiO2 will be increased to 100% with a fresh gas flow rate greater than or equal to 10 L.min-1. The ventilator will be stopped with the APL valve open to atmosphere. The patient will be manually ventilated with the reservoir bag until spontaneous ventilation resumes. Then, the patient may be manually assisted if the treating anesthesiologist deems it necessary. | Other | Emergence from general anesthesia with a conventional extubation strategy |
Primary outcome
Protocol adherence rate
Time frame: At the end of the surgery
During emergence from general anesthesia, a research assistant will observe the adherence to the protocol. The adherence rate will be defined as the number of extubations performed according to the protocol and the patient assigned group divided by the total number of awakenings. In the event of a breach of the protocol, the specific elements that led to the deviation will be noted as well as the reasons given by the treating anesthesiologist to justify it.
3 secondary outcomes
Number of eligible patients per week
Time frame: Through study completion, an average of 1 year
Rate of consent to participate in the protocol
Time frame: Through study completion, an average of 1 year
Rate of missing values
Time frame: Through study completion, an average of 1 year
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 31 May 2022.
- Derived from this study: PubMed 37498442Girard J, Zaouter C, Moore A, Carrier FM, Girard M. Effects of an open lung extubation strategy compared with a conventional extubation strategy on postoperative pulmonary complications after general anesthesia: a single-centre pilot randomized controlled trial. Can J Anaesth. 2023 Oct;70(10):1648-1659. doi: 10.1007/s12630-023-02533-z. Epub 2023 Jul 27.
- Individual participant dataSharing planned: No
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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.
Martin Girard, MD, FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open lung extubation and Conventional extubation in people with Anesthesia and Pulmonary Atelectasis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 2 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 31 May 2022. 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 Canada. 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?
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?
Protocol adherence rate (time frame: At the end of the surgery). 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 NCT04993001, 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 31 May 2022.