Clinical trial NCT06115668: Individualized Positive End-Expiratory Pressure (PEEP) on Oxygenation, Hemodynamics, and Early Postoperative Atelectasis in Laparoscopic Bariatric Surgery
Official title: Effects of Individualized Positive End-Expiratory Pressure (PEEP) on Oxygenation, Hemodynamic Variables, and Incidence of Early Postoperative Atelectasis in Patients Undergoing Laparoscopic Bariatric Surgery: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Positive End-expiratory Pressure
Hemodynamic Variable
Postoperative Atelectasis
Laparoscopic Bariatric Surgery
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effectiveness of intraoperative individualized positive end-expiratory pressure (PEEPIND) titration, compared to fixed positive end-expiratory pressure of 5 cmH2O, on oxygenation, hemodynamic variables, and early postoperative complications in obese patients undergoing laparoscopic bariatric surgery.

Detailed description: Obesity is a major health problem, and the incidence is increasing worldwide. So far, the only treatment for morbid obesity with good long-term results is bariatric surgery.

Obese patients have unique respiratory physiology and ventilatory mechanics characteristics. Their lung function is impaired due to the reduction of oxygen reserve, functional residual capacity, and lung compliance. In addition, they frequently present with respiratory comorbidities, which increases the risk of developing postoperative pulmonary complications (PPCs) such as atelectasis especially after procedures under general anesthesia. Atelectasis has been hypothesized as a main cause of postoperative hypoxemia.

To reduce the incidence of atelectasis, positive end-expiratory pressure (PEEP) and recruitment maneuvers are used as a protective lung strategy to improve gas exchange and lung mechanics through reopening collapsed alveoli and maintaining the aeration of lungs. Application of PEEP may also eliminate auto-PEEP without increasing plateau pressure.

Eligibility criteria: Inclusion Criteria:

* Age from 21 to 60 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status class I-III
* Patients who are scheduled for elective laparoscopic bariatric surgery under general anesthesia.

Exclusion Criteria:

* Patients who are unwilling to participate in the study
* Actively smokers.
* Patients who had a history of Chronic obstructive pulmonary disease or bronchial asthma.
* Patients who are receiving renal replacement therapy prior to surgery.
* Patients who had a history of heart failure.
* Pregnant.
* Patients who have allergies to any drug used in the study.

Primary outcomes:
measure: Intraoperative oxygenation
timeFrame: One hour after extubation
Secondary outcomes:
measure: Mean arterial pressure(MAP)
timeFrame: One hour after extubation
measure: Heart rate(HR)
timeFrame: One hour after extubation
measure: Volume of total fluid infusion
timeFrame: Till the end of surgery
measure: Dosage of vasopressors
timeFrame: Till the end of surgery
measure: Lung ultrasound scores
timeFrame: 12 hours postoperatively
measure: Early postoperative pulmonary complication
timeFrame: First 24 hours postoperatively
measure: Length of hospital stay
timeFrame: 28 days postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References: