Clinical trial NCT06619626: Alveolar Recruitment in Obese Patients in Major Gynaecological Cancer Surgery
Official title: The Effect of Alveolar Recruitment on Perioperative Outcomes in Obese Patients in Major Gynaecological Cancer Surgery: a Prospective Randomised Controlled Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gynecologic Cancers
Keywords: gynecologic cancer surgery
alveolar recruitment strategy
positive end-expiratory pressure
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: As a result of power analysis, the minimum sample size was determined as 16 for each group with an effect size of 1.2, a 5% margin of error and 95% power. We planned 20 patients for each group due to data losses and deficiencies.

Brief summary: In this study, the investigators planned to evaluate the effect of alveolar recruitment strategy primarily on postoperative pulmonary complications in obese patients undergoing lung protective ventilation in major open gynaeco-oncological surgeries. Our other aim was to evaluate perioperative haemodynamics, respiratory mechanics,inpatient length of stay.

Detailed description: In the gynaecological oncology clinic of our hospital, open major surgeries for endometrial or ovarian cancer are performed very frequently. In these surgeries, the abdomen is open to the operating theatre environment and the lithotomy and trendelenburg position may have negative consequences on the respiratory system in patients. Intraoperative lung protective ventilation strategies are recommended to reduce postoperative pulmonary complications. In the lung protective ventilation strategy, positive end-expiratory pressure is recommended in addition to 6-8 ml/kg tidal volume according to ideal body weight. In addition, alveolar recruitment strategy can be applied. For this purpose, the investigators planned to evaluate the effect of alveolar recruitment strategy on postoperative pulmonary complications in patients who underwent lung protective ventilation in major open gynaecooncological surgeries. Our secondary aim was to evaluate perioperative haemodynamics, respiratory mechanics, inpatient length of stay.

Eligibility criteria: Inclusion Criteria:

* Patients with ASAII and III
* BMI\>30 kg/m2 ,\<40 kg/m2
* Patients with an ARISCAT risk score of 26-44

Exclusion Criteria:

* Patients with an Assessment of Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) risk score \> 44
* BMI \> 40 kg/m2 patients

Primary outcomes:
measure: postoperative pulmonary complications
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: intraoperative haemodynamic parameters
timeFrame: intraoperatively
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Duygu Akyol
Study officials:
affiliation: Başakşehir Çam & Sakura City Hospital
name: Duygu Akyol
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pereira SM, Tucci MR, Morais CCA, Simoes CM, Tonelotto BFF, Pompeo MS, Kay FU, Pelosi P, Vieira JE, Amato MBP. Individual Positive End-expiratory Pressure Settings Optimize Intraoperative Mechanical Ventilation and Reduce Postoperative Atelectasis. Anesthesiology. 2018 Dec;129(6):1070-1081. doi: 10.1097/ALN.0000000000002435.
citation: Park SH. Perioperative lung-protective ventilation strategy reduces postoperative pulmonary complications in patients undergoing thoracic and major abdominal surgery. Korean J Anesthesiol. 2016 Feb;69(1):3-7. doi: 10.4097/kjae.2016.69.1.3. Epub 2016 Jan 28.
citation: Spieth PM, Guldner A, Uhlig C, Bluth T, Kiss T, Conrad C, Bischlager K, Braune A, Huhle R, Insorsi A, Tarantino F, Ball L, Schultz MJ, Abolmaali N, Koch T, Pelosi P, Gama de Abreu M; PROtective Ventilation (PROVE) Network. Variable versus conventional lung protective mechanical ventilation during open abdominal surgery (PROVAR): a randomised controlled trial. Br J Anaesth. 2018 Mar;120(3):581-591. doi: 10.1016/j.bja.2017.11.078. Epub 2017 Dec 1.