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Clinical Trials/NCT06619626
NCT06619626
Recruiting
Not Applicable

The Effect of Alveolar Recruitment on Perioperative Outcomes in Obese Patients in Major Gynaecological Cancer Surgery: a Prospective Randomised Controlled Trial

Bakirkoy Dr. Sadi Konuk Research and Training Hospital1 site in 1 country40 target enrollmentJanuary 1, 2024

Overview

Phase
Not Applicable
Intervention
alveolar recruitment strategy applied group
Conditions
Gynecologic Cancers
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Enrollment
40
Locations
1
Primary Endpoint
postoperative pulmonary complications
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
November 30, 2024
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Responsible Party
Principal Investigator
Principal Investigator

Duygu Akyol

Principal Investigator

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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

Arms & Interventions

Group 1, lung protective ventilation with alveolar recruitment

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.

Intervention: alveolar recruitment strategy applied group

Group 1, lung protective ventilation with alveolar recruitment

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.

Intervention: group without alveolar recruitment strategy

Group 2, lung protective ventilation without alveolar recruitment

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.

Intervention: alveolar recruitment strategy applied group

Group 2, lung protective ventilation without alveolar recruitment

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.

Intervention: group without alveolar recruitment strategy

Outcomes

Primary Outcomes

postoperative pulmonary complications

Time Frame: 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 Outcomes

  • intraoperative haemodynamic parameters(intraoperatively)

Study Sites (1)

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