Clinical trial NCT03551899: Intra-operative Ventilatory Management & Post-operative Pulmonary Complications
Official title: An Observational Study of Intra-operative Ventilatory Management & Post-operative Pulmonary Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intra-Operative Ventilatory Management
Post-Operative Complications
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2018-06-11
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical patients undergoing general anesthesia

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Intra-operative surgical procedures
timeFrame: 2 hours
measure: Intra-operative mechanical ventilation management
timeFrame: 2 hours
Secondary outcomes:
measure: Post-operative complications that could be associated with particular settings
timeFrame: 1 week
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: AUBMC
city: Beirut
country: Lebanon
facility: jean Beresian
Study officials:
References: