Clinical trial NCT06402474: Effect of Two Different Surgical Positions on Pulmonary Functions in Laparoscopic Gastrectomies
Official title: Effect of Two Different Surgical Positions on Pulmonary Functions in Laparoscopic Gastrectomies
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pulmonary Pathology
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18-65 who underwent laparoscopic sleeve gastrectomy

Brief summary: The primary purpose of the study is to investigate the effect of the 30° reverse trendelenburg position combined with the sunbed position on respiratory parameters in laparoscopic gastrectomies.


Eligibility criteria: Inclusion Criteria:

* Patients who can tolerate general anesthesia and pneumoperitoneum.
* Patients who can give informed consent for surgery.
* Patients over 18 years of age
* patients with body mass index (BMI) \> 30 kg/m2
* Patients with American Society of Anesthesiologists (ASA) physical status I and II

Exclusion Criteria:

* Patients with serious underlying cardiovascular disease (e.g. congestive heart failure, conduction disorders and ischemic heart disease).
* Patients with chronic kidney disease stage 3 or greater (creatinine clearance less than 60 mL/min).
* patients with a history of cerebrovascular disease such as intracranial hypertension, cerebral infarction, cerebral hemorrhage, carotid artery stenosis or cerebral ischemia;
* Patients with a history of chronic lung diseases such as chronic obstructive pulmonary disease, asthma, pulmonary bullae or respiratory failure;
* Patients who have had previous abdominal surgery, including resection of the esophagus, stomach, liver and pancreas.
* Surgeries lasting longer than 90 minutes
* Patients with ASA class IV
* patients with psychiatric disorders
* pregnant or breastfeeding patients
* patients with a history of seizures

Primary outcomes:
measure: inspiratory pressure
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istinye Üniversity
state: Merkez Mahallesi
Study officials:
References:
citation: Casati A, Comotti L, Tommasino C, Leggieri C, Bignami E, Tarantino F, Torri G. Effects of pneumoperitoneum and reverse Trendelenburg position on cardiopulmonary function in morbidly obese patients receiving laparoscopic gastric banding. Eur J Anaesthesiol. 2000 May;17(5):300-5. doi: 10.1046/j.1365-2346.2000.00662.x.
citation: Wang Y, Wang H, Wang H, Zhao X, Li S, Chen L. Exploring the intraoperative lung protective ventilation of different positive end-expiratory pressure levels during abdominal laparoscopic surgery with Trendelenburg position. Ann Transl Med. 2019 Apr;7(8):171. doi: 10.21037/atm.2019.03.45.
citation: Shono A, Katayama N, Fujihara T, Bohm SH, Waldmann AD, Ugata K, Nikai T, Saito Y. Positive End-expiratory Pressure and Distribution of Ventilation in Pneumoperitoneum Combined with Steep Trendelenburg Position. Anesthesiology. 2020 Mar;132(3):476-490. doi: 10.1097/ALN.0000000000003062.
citation: Mulier JP, Dillemans B, Van Cauwenberge S. Impact of the patient's body position on the intraabdominal workspace during laparoscopic surgery. Surg Endosc. 2010 Jun;24(6):1398-402. doi: 10.1007/s00464-009-0785-8. Epub 2010 Jan 7.
citation: Gao D, Sun L, Wang N, Shi Y, Song J, Liu X, Yang Q, Su Z. Impact of 30 degrees Reserve Trendelenburg Position on Lung Function in Morbidly Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy. Front Surg. 2022 Feb 24;9:792697. doi: 10.3389/fsurg.2022.792697. eCollection 2022.