NCT03551899

Intra-operative Ventilatory Management & Post-operative Pulmonary Complications

Completed Last updated 12 April 2022

What this trial tests

trial testing Different ventilation parameters in Intra-Operative Ventilatory Management in 218 participants. Completed in 23 July 2020.

Timeline

24 February 2017

Primary endpoint
23 July 2020

23 July 2020

Quick facts

Lead sponsor	American University of Beirut Medical Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	218
Start date	24 February 2017
Primary completion	23 July 2020
Estimated completion	23 July 2020
Sites	2 locations across Lebanon

Drugs / interventions tested

• Different ventilation parameters

Conditions studied

• Intra-Operative Ventilatory Management — all drugs for Intra-Operative Ventilatory Management →
• Post-Operative Complications — all drugs for Post-Operative Complications →

Sponsor

American University of Beirut Medical Center

Who can join

18 and older, any sex, with Intra-Operative Ventilatory Management or Post-Operative Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: The list of studies with inconsistent data regarding the effect of intra-operative ventilatory management on post-operative lung injury is large. The literature is lacking data on the least injurious way of ventilating surgical patients intra-operatively. This study is necessary to support future guidelines on the practice of intra-operative mechanical ventilation.

Specific Aim: The aims of this study is first to describe intra-operative ventilatory practices at the American University of Beirut Medical Center (AUBMC), (with particular focus on the mode of ventilation, tidal volume per body weight and PEEP settings) and second, to identify the post-operative complications that could be associated with particular settings.

Methodology: This is a prospective observational study that will be conducted in the operating room at AUBMC, on patients being admitted for surgeries under general anesthesia. During the patient's stay in the hospital, targeted process (patient characteristics, surgical procedure, mechanical ventilation management, anesthesiologist characteristics) and outcomes parameters (postoperative pulmonary complications) will be collected for analysis. Patients will be monitored and followed up with intraoperatively and postoperatively.

Analysis: Different parameters and outcomes will be collected and by subgrouping the patients per their medical history statistical significance will be tested to reach a correlative analysis to the outcomes documented. Statistical comparison will be made using the ANOVA, Student's t-test, and Chi-squared test. Level of statistical significance will be considered at p\<0.05. Mean age, weight, height and BMI of participants in the different groups will be calculated. ANOVA test will be performed to test statistical significance to compare the different means between different subgroups. A two sided P value of less than 0.05 was considered to be significant Significance: The literature is lacking data on the least injurious way of ventilating surgical patients intra-operatively. This study is necessary to support future guidelines on the practice of intra-operative mechanical ventilation

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Intraoperative mechanical power and postoperative pulmonary complications in low-risk surgical patients: a prospective observational cohort study.
   El-Khatib M, Zeeni C, Shebbo FM, Karam C, et al · · 2024 · cited 9× · PMID 38413871 · DOI 10.1186/s12871-024-02449-1