Impact of an Open Lung Extubation Strategy on Postoperative Pulmonary Complications
Primary Purpose
Anesthesia, Pulmonary Atelectasis, Complication of Anesthesia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Open lung extubation
Conventional extubation
Sponsored by
About this trial
This is an interventional prevention trial for Anesthesia focused on measuring Open lung extubation strategy, Postoperative pulmonary complications
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- Patient refusal
Ultrasound sub-study:
- Body mass index greater than 40 kg.m-2
- Extensive postoperative chest dressings
- Clinician's refusal to participate
Sites / Locations
- Centre hospitalier de l'Université de Montréal (CHUM)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Emergence from general anesthesia with an open lung extubation strategy
Emergence from general anesthesia with a conventional extubation strategy
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of eligible patients per week
Rate of consent to participate in the protocol
Rate of missing values
Full Information
NCT ID
NCT04993001
First Posted
July 26, 2021
Last Updated
May 27, 2022
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
1. Study Identification
Unique Protocol Identification Number
NCT04993001
Brief Title
Impact of an Open Lung Extubation Strategy on Postoperative Pulmonary Complications
Official Title
Impact of an Open Lung Extubation Strategy on Postoperative Pulmonary Complications Compared to a Conventional Extubation Strategy: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 3, 2021 (Actual)
Primary Completion Date
December 17, 2021 (Actual)
Study Completion Date
January 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Pulmonary Atelectasis, Complication of Anesthesia
Keywords
Open lung extubation strategy, Postoperative pulmonary complications
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot, single-center, randomized, triple-blind controlled study
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Emergence from general anesthesia with an open lung extubation strategy
Arm Type
Active Comparator
Arm Title
Emergence from general anesthesia with a conventional extubation strategy
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Open lung extubation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional extubation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Protocol adherence rate
Description
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.
Time Frame
At the end of the surgery
Secondary Outcome Measure Information:
Title
Number of eligible patients per week
Time Frame
Through study completion, an average of 1 year
Title
Rate of consent to participate in the protocol
Time Frame
Through study completion, an average of 1 year
Title
Rate of missing values
Time Frame
Through study completion, an average of 1 year
Other Pre-specified Outcome Measures:
Title
Estimated baseline rates of postoperative respiratory complications in the two intervention groups
Description
Postoperative pulmonary complications will be defined using the definition recommended by the StEP group. These will be compiled from the patient's arrival in the recovery room until the 7th postoperative day or, if earlier, until discharge from hospital. Adjudication of complications will be performed by 2 investigators blinded to the treatment group. Any disagreement will be resolved by discussion between the two reviewers.
Time Frame
7 days following the patient enters the recovery room
Title
Comparison of pulmonary aeration using the qLUS score in the two intervention groups
Description
A lung ultrasound will be performed on each patient during pre-emergence preparations and 15 minutes after the patient arrives in the recovery room. The quantitative Lung Ultrasound Score will be calculated for each ultrasound examination. The physician performing the ultrasound examinations will be kept blind from the intervention group.
Time Frame
15 minutes after the patient enters the recovery room
Title
Re-intubation rate in the operating room
Time Frame
At the end of the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Patient refusal
Ultrasound sub-study:
Body mass index greater than 40 kg.m-2
Extensive postoperative chest dressings
Clinician's refusal to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Girard, MD, FRCPC
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier de l'Université de Montréal (CHUM)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of an Open Lung Extubation Strategy on Postoperative Pulmonary Complications
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