Clinical trial NCT04861168: Driving Pressure Guided Ventilation Versus Conventional Lung Protective Strategy in Morbid Obese Patients Undergoing Laparoscopic Bariatric Surgery
Official title: Driving Pressure Guided Ventilation Versus Conventional Lung Protective Strategy in Morbid Obese Patients Undergoing Laparoscopic Bariatric Surgery; a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Driving Pressure
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Intraoperative oxygenation measured by the arterial partial pressure of oxygen (PaO2).
timeFrame: the time of surgery
Secondary outcomes:
measure: the need for rescue recruitment
timeFrame: the time of surgery
measure: incidence of early postoperative pulmonary complications e.g., postoperative hypoxia, the need for supplementary oxygen, atelectasis, barotrauma, and respiratory failure.
timeFrame: First 24 hours postoperative
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
city: Tanta
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.