Driving Pressure Guided Ventilation Versus Conventional Lung Protective Strategy in Morbid Obese Patients Undergoing Laparoscopic Bariatric Surgery

Driving Pressure Guided Ventilation Versus Conventional Lung Protective Strategy in Morbid Obese Patients Undergoing Laparoscopic Bariatric Surgery; a Prospective Randomized Controlled Study

This study will be conducted to evaluate the effect of driving pressure guided ventilation compared with conventional protective lung ventilation during laparoscopic bariatric surgeries in morbid obese patients.

• the primary outcome: Intraoperative oxygenation measured by the arterial partial pressure of oxygen (PaO2).
• the secondary outcome: incidence of early postoperative pulmonary complications e.g., postoperative hypoxia, the need for supplementary oxygen, atelectasis, barotrauma, and respiratory failure.

Study Overview

• Status: Completed
• Conditions: Driving Pressure
• Intervention / Treatment: Procedure: driving pressure guided ventilation; Procedure: Conventional protective lung strategy

Detailed Description

Protective mechanical ventilation during anesthesia aims at minimizing lung injury and has been associated to a decrease in postoperative pulmonary complications (PPCs). Conventional protective ventilation strategy is consisted of the use of a low tidal volume (VT) and fixed moderate positive end expiratory pressure (peep). However, low-VT may result in the reduction of the functional volume of the lung manifested as lung collapse. Another potential consequence of lung collapse is the impairment in ventilatory efficiency.

Bariatric surgery is proven to achieve significant and sustained weight loss in the morbidly obese. Major weight loss can lead to partial/complete resolution of a range of conditions including, diabetes mellitus, ischemic heart disease, and hypertension.

Obese patients undergoing general anesthesia and mechanical ventilation during abdominal and bariatric surgeries commonly have a higher incidence of postoperative pulmonary complications (PPCs), due to factors such as decreasing oxygen reserve, declining functional residual capacity, and reducing lung compliance. And also pneumoperitoneum aggravates pulmonary atelectasis caused by mechanical ventilation, especially in obese patients.

Driving pressure (DP) which is the difference between the airway pressure at the end of inspiration (plateau pressure, (Ppl) and PEEP was first introduced by Amato et al in 2015 in their meta-analy¬sis study for ARDS patients. The authors suggested that driving pressure is the stronger predictor of mortality as compared with low VT and Ppl.

Several retrospec¬tive and prospective studies confirmed the importance of driving pressure in ARDS pa¬tients and during general anesthesia without differentiation between obese and nonobese patients .only one retrospective study showed that driving pressure was not associated with mortality in obese-ARDS patients. we hypothesize that these results may be different in obese patients having healthy lungs.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt, 31511
    • Tanta University Hospitals
  • Tanta, Egypt
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• sixty patients have a BMI 40-50 kg/m2, ASA physical status III, aged between 18 and 60 years, scheduled to undergo laparoscopic bariatric surgeries.

Exclusion Criteria:

• patient refusal to participate in the study.
• Patients had a recent history of severe respiratory disease and previous major pulmonary surgeries.
• patients who are contraindicated with application of PEEP (high intracranial pressure, bronchopleural fistula, hypovolemic shock, right ventricular failure).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Driving pressure guided ventilation; Patients will be mechanically ventilated with driving pressure guided ventilation with VT 6-8 ml /kg of predicted body weight, and after recruitment we will return to the baseline PEEP 5 cmH2O that will be increased by 2 cmH2O until reaching the lowest possible driving pressure for every patient. Each PEEP level will be applied for 10 respiratory cycles and DP will be calculated at the last cycle.	Procedure: driving pressure guided ventilation; driving pressure guided ventilation
Active Comparator: Conventional protective lung strategy; Patients will be mechanically ventilated with conventional protective lung strategy with VT 6-8 ml /kg of predicted body weight, after recruitment, we will return to the baseline PEEP 5 cmH2O and will be maintained until the end of surgery.	Procedure: Conventional protective lung strategy; Conventional protective lung strategy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative oxygenation measured by the arterial partial pressure of oxygen (PaO2).	Arterial blood gases -for measurement of pao2- will be sampled after induction of anesthesia (baseline) ,10 minutes after recruitment, before end of surgery, and 30 minutes after extubation.	the time of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the need for rescue recruitment	the need for rescue recruitment	the time of surgery
incidence of early postoperative pulmonary complications e.g., postoperative hypoxia, the need for supplementary oxygen, atelectasis, barotrauma, and respiratory failure.	ncidence of early postoperative pulmonary complications e.g., postoperative hypoxia, the need for supplementary oxygen, atelectasis, barotrauma, and respiratory failure.	First 24 hours postoperative

Collaborators and Investigators

• Sponsor: Tanta University

Publications and helpful links

General Publications

• Serpa Neto A, Hemmes SN, Barbas CS, Beiderlinden M, Biehl M, Binnekade JM, Canet J, Fernandez-Bustamante A, Futier E, Gajic O, Hedenstierna G, Hollmann MW, Jaber S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Putensen C, Ranieri M, Scavonetto F, Schilling T, Schmid W, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Gama de Abreu M, Pelosi P, Schultz MJ; PROVE Network Investigators. Protective versus Conventional Ventilation for Surgery: A Systematic Review and Individual Patient Data Meta-analysis. Anesthesiology. 2015 Jul;123(1):66-78. doi: 10.1097/ALN.0000000000000706.
• Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.
• Unzueta C, Tusman G, Suarez-Sipmann F, Bohm S, Moral V. Alveolar recruitment improves ventilation during thoracic surgery: a randomized controlled trial. Br J Anaesth. 2012 Mar;108(3):517-24. doi: 10.1093/bja/aer415. Epub 2011 Dec 26.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Actual): September 15, 2024
• Study Completion (Actual): April 15, 2025

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 28, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Driving pressure ventilation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No