Alveolar Recruitment in Obese Patients in Major Gynaecological Cancer Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorBakirkoy Dr. Sadi Konuk Research and Training Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with ASAII and III

BMI>30 kg/m2 ,<40 kg/m2

Patients with an ARISCAT risk score of 26-44

Disqualifiers

Patients with an Assessment of Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) risk score > 44

BMI > 40 kg/m2 patients

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • alveolar recruitment strategy applied group

    Device

    the effect of alveolar recruitment strategy on the mechanical parameters of the patients

  • group without alveolar recruitment strategy

    Drug

    effect on mechanical parameters of patients without alveolar recruitment strategy

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Group 1, lung protective ventilation with alveolar recruitment2 interventions
Group B: Group 2, lung protective ventilation without alveolar recruitment2 interventions

Trial outcomes

Primary outcomes

1

postoperative pulmonary complications

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.

Time frame
24 hours postoperatively

Secondary outcomes

1

intraoperative haemodynamic parameters

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

Time frame
intraoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.