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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04861168
Enrollment
60
Registered
2021-04-27
Start date
2023-09-15
Completion date
2025-04-15
Last updated
2025-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Driving Pressure

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.

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.

Interventions

driving pressure guided ventilation

PROCEDUREConventional protective lung strategy

Conventional protective lung strategy

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative oxygenation measured by the arterial partial pressure of oxygen (PaO2).the time of surgeryArterial 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.

Secondary

MeasureTime frameDescription
the need for rescue recruitmentthe time of surgerythe need for rescue recruitment
incidence of early postoperative pulmonary complications e.g., postoperative hypoxia, the need for supplementary oxygen, atelectasis, barotrauma, and respiratory failure.First 24 hours postoperativencidence of early postoperative pulmonary complications e.g., postoperative hypoxia, the need for supplementary oxygen, atelectasis, barotrauma, and respiratory failure.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026