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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04861168
Other study ID # Driving pressure ventilation
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 15, 2021
Est. completion date December 15, 2021

Study information

Verified date April 2021
Source Tanta University
Contact Mohamed Elbehairy
Phone 00201024259293
Email mohamedseadana@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 15, 2021
Est. primary completion date November 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
driving pressure guided ventilation
driving pressure guided ventilation
Conventional protective lung strategy
Conventional protective lung strategy

Locations

Country Name City State
Egypt Tanta University Hospitals Tanta

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View 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. Review. — View Citation

Unzueta C, Tusman G, Suarez-Sipmann F, Böhm 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 the need for rescue recruitment the time of surgery
Secondary incidence of early postoperative pulmonary complications e.g., postoperative hypoxia, the need for supplementary oxygen, atelectasis, barotrauma, and respiratory failure. First 24 hours postoperative
See also
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Not yet recruiting NCT04391387 - Clinical Impact of Different Duration Prone Postition Treatment for Patients With ARDS. N/A
Recruiting NCT03616704 - Effects of Different Driving Pressure on Lung Stress, Strain and Mechanical Power in Patients With Moderate to Severe ARDS
Completed NCT02851238 - Driving Pressure and Postoperative Pulmonary Complications N/A