Alveolar Recruitment in Obese Patients in Major Gynaecological Cancer Surgery

Recruiting

• Conditions: Gynecologic Cancers
• Interventions: Device: alveolar recruitment strategy applied group; Drug: group without alveolar recruitment strategy

• Registration Number: NCT06619626
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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.

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-27
• Study First Posted: 2024-10-01
• Last Update Submitted: 2024-10-05
• Last Update Posted: 2024-10-09
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1, lung protective ventilation with alveolar recruitment	alveolar recruitment strategy applied group	In mechanical ventilation volume controlled ventilation (VCV) mode, tidal volume (TV) is 6-8 ml/kg according to ideal body weight, positive end expiratory pressure (PEEP): 8 cmH2O, end tidal carbon dioxide pressure (etCO2): 35-45 mmHg, the number of breaths will be adjusted and ventilation will be started. After 10 minutes of ventilation, alveolar recruitment manoeuvre will be started by switching the mechanical ventilator to pressure controlled ventilation (PCV) mode in patients in whom alveolar recruitment strategy (ARS) will be applied. PEEP will be 30 cmHg with 2 unit increases in PEEP for 2 minutes each ventilation will be applied until PEEP reaches 20. When the mean arterial pressure decreases more than 20%, recruitment will be terminated. PEEP will be restored when PEEP 20 is reached. Mechanical ventilation will be switched to VCV mode.
Group 1, lung protective ventilation with alveolar recruitment	group without alveolar recruitment strategy	In mechanical ventilation volume controlled ventilation (VCV) mode, tidal volume (TV) is 6-8 ml/kg according to ideal body weight, positive end expiratory pressure (PEEP): 8 cmH2O, end tidal carbon dioxide pressure (etCO2): 35-45 mmHg, the number of breaths will be adjusted and ventilation will be started. After 10 minutes of ventilation, alveolar recruitment manoeuvre will be started by switching the mechanical ventilator to pressure controlled ventilation (PCV) mode in patients in whom alveolar recruitment strategy (ARS) will be applied. PEEP will be 30 cmHg with 2 unit increases in PEEP for 2 minutes each ventilation will be applied until PEEP reaches 20. When the mean arterial pressure decreases more than 20%, recruitment will be terminated. PEEP will be restored when PEEP 20 is reached. Mechanical ventilation will be switched to VCV mode.
Group 2, lung protective ventilation without alveolar recruitment	alveolar recruitment strategy applied group	In mechanical ventilation volume controlled ventilation (VCV) mode, tidal volume (TV) is 6-8 ml/kg according to ideal body weight, positive end expiratory pressure (PEEP): 8 cmH2O, end tidal carbon dioxide pressure (etCO2): 35-45 mmHg, ventilation will be provided by adjusting the number of breaths.
Group 2, lung protective ventilation without alveolar recruitment	group without alveolar recruitment strategy	In mechanical ventilation volume controlled ventilation (VCV) mode, tidal volume (TV) is 6-8 ml/kg according to ideal body weight, positive end expiratory pressure (PEEP): 8 cmH2O, end tidal carbon dioxide pressure (etCO2): 35-45 mmHg, ventilation will be provided by adjusting the number of breaths.

Primary Outcome Measures

Name	Time	Method
postoperative pulmonary complications	24 hours postoperatively	Our primary aim was to compare the presence of postoperative pulmonary complications. The presence of these pulmonary complications will be compared between preoperative chest X-ray and postoperative day 1 X-ray imaging in patients with Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) risk score below 44.

Secondary Outcome Measures

Name	Time	Method
intraoperative haemodynamic parameters	intraoperatively	Our secondary aim was to evaluate intraoperative haemodynamic parameter(mean arterial pressure) in alveolar recruitment strategy in lung-protective ventilation.

Trial Locations

Locations (1)

Duygu Akyol; 🇹🇷 Istanbul, Turkey