Intra-operative Ventilatory Management & Post-operative Pulmonary Complications

Post-Operative Complications Clinical Trial

Official title:

An Observational Study of Intra-operative Ventilatory Management & Post-operative Pulmonary Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03551899
• Other study ID #: ANES.JB.01
• Status: Completed
• Start date: February 24, 2017
• Est. completion date: July 23, 2020

Study information

• Verified date: April 2022
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: July 23, 2020
• Est. primary completion date: July 23, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. surgeries undergone under general anesthesia

2. patients above 18 years old

3. patient able to give consent

4. American Society of Anesthesiologists (ASA) = 1 to 4

Exclusion criteria:

1. Patients unable to give consent

2. Patients below 18 years old.

3. Surgeries done under spinal anesthesia or local block or under sedation.

4. Patients admitted to Intensive care unit post-operative due to surgical complications.

Related Conditions & MeSH terms

• Intra-Operative Ventilatory Management
• Post-Operative Complications
• Postoperative Complications

Intervention

Other:
• Different ventilation parameters
mode of ventilation, tidal volume per body weight and PEEP settings

Locations

Country	Name	City	State
Lebanon	AUBMC	Beirut
Lebanon	jean Beresian	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-operative surgical procedures	Type and duration (in minutes) of the surgical procedure	2 hours
Primary	Intra-operative mechanical ventilation management	Ventilation mode and settings	2 hours
Secondary	Post-operative complications that could be associated with particular settings	atelectasis, pneumonia, aspiration, acute respiratory distress syndrome (ARDS)	1 week