Anesthesia Clinical Trial
Official title:
Impact of an Open Lung Extubation Strategy on Postoperative Pulmonary Complications Compared to a Conventional Extubation Strategy: a Pilot Study
Verified date | May 2022 |
Source | Centre hospitalier de l'Université de Montréal (CHUM) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 69 |
Est. completion date | January 17, 2022 |
Est. primary completion date | December 17, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Centre hospitalier de l'Université de Montréal (CHUM) | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre hospitalier de l'Université de Montréal (CHUM) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Estimated baseline rates of postoperative respiratory complications in the two intervention groups | 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. | 7 days following the patient enters the recovery room | |
Other | Comparison of pulmonary aeration using the qLUS score in the two intervention groups | 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. | 15 minutes after the patient enters the recovery room | |
Other | Re-intubation rate in the operating room | At the end of the surgery | ||
Primary | 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. | At the end of the surgery | |
Secondary | Number of eligible patients per week | Through study completion, an average of 1 year | ||
Secondary | Rate of consent to participate in the protocol | Through study completion, an average of 1 year | ||
Secondary | Rate of missing values | Through study completion, an average of 1 year |
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