Individualized Positive End-Expiratory Pressure (PEEP) on Oxygenation, Hemodynamics, and Early Postoperative Atelectasis in Laparoscopic Bariatric Surgery

Positive End-expiratory Pressure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06115668
• Other study ID #: 36131/11/22
• Status: Recruiting
• Phase: N/A
• Start date: November 5, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: November 2023
• Source: Tanta University
• Contact: Heba Z Khattab, Master
• Phone: 00201004774825
• Email: hebazakaria194[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laparoscopic Bariatric Surgery
• Positive End-expiratory Pressure
• Postoperative Atelectasis
• Pulmonary Atelectasis

Intervention

Other:
• Positive end-expiratory pressure 5 (PEEP 5)
Fixed positive end-expiratory pressure of 5 cmH2O will be maintained throughout the duration of surgery
• Individualized positive end-expiratory pressure (PEEPIND)
Patients will receive the individualized positive end-expiratory pressure. Titration process will be started after establishment of pneumoperitoneum: setting the initial PEEP to 5 cmH2O, then increasing positive end-expiratory pressure (PEEP)according to the gradient of 2 cmH2O every 3 min, calculating static compliance (Cstat) according to the formula: [Cstat = VT/Pplat - PEEP] (Pplat = plateau pressure), then gradually increasing positive end-expiratory pressure , until the calculated Cstat shows a downward trend, set its previous PEEP (corresponding to PEEP for high Cstat) as the optimal PEEPIND for this patient. The highest PEEP is limited to 20 cmH2O

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative oxygenation	Intraoperative oxygenation which will be assessed by P/F ratio (the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage).; PaO2/FiO2: will be measured at before induction of anesthesia, immediately after intubation, after PEEP titration, one hour after pneumoperitoneum, before extubation, one hour after extubation	One hour after extubation
Secondary	Mean arterial pressure(MAP)	Mean arterial pressure will be measured before induction of anesthesia, immediately after intubation, after positive End-Expiratory Pressure titration, one hour after pneumoperitoneum, before extubation, and one hour after extubation.	One hour after extubation
Secondary	Heart rate(HR)	Heart rate will be measured before induction of anesthesia, immediately after intubation, after positive End-Expiratory Pressure titration, one hour after pneumoperitoneum, before extubation, and one hour after extubation.	One hour after extubation
Secondary	Volume of total fluid infusion	The total volume of the administered fluids will be recorded.	Till the end of surgery
Secondary	Dosage of vasopressors	The total volume of the administered vasopressors will be recorded.	Till the end of surgery
Secondary	Lung ultrasound scores	Lung ultrasound scans will be performed 3 times for each patient, before induction of anesthesia, one hour after extubation and 12 hours postoperatively.; Patients will be scanned in the supine position as follows: Each hemithorax will be divided into 6 regions using 3 longitudinal lines (parasternal, anterior, and posterior axillary) and 2 axial lines (one above the diaphragm and the other 1 cm above the nipples). The 12-lung regions will be scanned sequentially from right to left, cranial to caudal and anterior to posterior. Each region will be assessed using a 2-dimensional view with the probe placed parallel to the ribs. The degree of B-lines will be divided into 4 grades according to lung ultrasound score for consolidation and aeration and scored between 0 and 3: (0) fewer than 3 isolated B-lines.; multiple well-defined B-lines.; multiple coalescent B-lines.; white lung.	12 hours postoperatively
Secondary	Early postoperative pulmonary complication	Any early postoperative pulmonary complication in the first postoperative 24 hours will be recorded.	First 24 hours postoperatively
Secondary	Length of hospital stay	Time from admission till hospital discharge	28 days postoperatively