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

NCT04861168 | Completed

• 1 other identifier: Driving pressure ventilation
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Driving Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

  First 24 hours postoperative

Study Arms (2)

Driving pressure guided ventilation

EXPERIMENTAL

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

Conventional protective lung strategy

ACTIVE COMPARATOR

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

Interventions

driving pressure guided ventilation PROCEDURE

driving pressure guided ventilation

Driving pressure guided ventilation

Conventional protective lung strategy PROCEDURE

Conventional protective lung strategy

Conventional protective lung strategy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tanta University: lead

Study Sites (2)

Tanta University Hospitals

Tanta, 31511, Egypt

Location

Faculty of Medicine

Tanta, Egypt

Location

Related Publications (4)

• 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.

  PMID: 25978326 BACKGROUND

• 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.

  PMID: 22201185 BACKGROUND

• 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.

  PMID: 25693014 BACKGROUND

• Elbehairy MS, Eid GM, Elzeftawy AE, Elsheikh NA, Messbah WE. Driving pressure guided ventilation versus conventional lung protective strategy in morbid obese patients undergoing laparoscopic bariatric surgery: a prospective randomized controlled study. BMC Anesthesiol. 2025 Nov 20;25(1):577. doi: 10.1186/s12871-025-03431-1.

  PMID: 41266983 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant lecturer

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: April 27, 2021
• Study Start: September 15, 2023
• Primary Completion: September 15, 2024
• Study Completion: April 15, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)