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Alveolar Recruitment in Obese Patients in Major Gynaecological Cancer Surgery

B

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Status

Enrolling

Conditions

Gynecologic Cancers

Treatments

Drug: group without alveolar recruitment strategy
Device: alveolar recruitment strategy applied group

Study type

Observational

Funder types

Other

Identifiers

NCT06619626
2023-583

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Group 1, lung protective ventilation with alveolar recruitment
Description:
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.
Treatment:
Device: alveolar recruitment strategy applied group
Drug: group without alveolar recruitment strategy
Group 2, lung protective ventilation without alveolar recruitment
Description:
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.
Treatment:
Device: alveolar recruitment strategy applied group
Drug: group without alveolar recruitment strategy

Trial contacts and locations

1

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Central trial contact

Duygu Akyol

Data sourced from clinicaltrials.gov

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