Flow-Controlled vs Volume-Controlled Ventilation in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAnkara Training and Research Hospital

About this trial

The goal of this clinical trial is to compare the effects of flow-controlled ventilation (FCV) and volume-controlled ventilation (VCV) on hemodynamic and respiratory parameters in obese patients undergoing elective laparoscopic bariatric surgery. The main questions it aims to answer are:

Does FCV provide better intraoperative hemodynamic and respiratory stability compared to VCV during laparoscopic bariatric surgery? Is FCV a safe and feasible ventilation strategy under high intraabdominal pressure and position changes required in bariatric surgery?

Researchers will compare FCV group to VCV group to see if FCV improves intraoperative respiratory mechanics and hemodynamic parameters.

Participants will:

Undergo elective laparoscopic bariatric surgery with BMI \>40 kg/m² (ASA I-III) Receive either flow-controlled or volume-controlled ventilation with individualized PEEP and tidal volume of 6-8 ml/kg predicted body weight Have intraoperative hemodynamic and respiratory parameters monitored at regular intervals, including arterial blood gas analysis Be followed postoperatively for oxygen therapy requirement and intensive care need

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 65 years American Society of Anesthesiologists (ASA) physical status I, II, or III Body Mass Index (BMI) ≥ 40 kg/m² Scheduled for elective laparoscopic bariatric surgery Willing to participate in the study

Disqualifiers

ASA physical status IV or V Emergency surgical procedures Pregnant patients Patients requiring vasopressor support to maintain mean arterial pressure above 65 mmHg intraoperatively Patients with advanced pulmonary disease Patients who decline to participate in the study

Trial population

Adult morbidly obese patients (BMI ≥40 kg/m²) aged 18-65 years, classified as ASA I-III, scheduled for elective laparoscopic bariatric surgery at Ankara Training and Research Hospital.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Flow-Controlled Ventilation (FCV)

    Device

    Patients were ventilated using flow-controlled ventilation with a tidal volume of 6-8 ml/kg predicted body weight. PEEP was individualized based on respiratory compliance following CO₂ insufflation.

  • Volume-Controlled Ventilation (VCV)

    Device

    Patients were ventilated using volume-controlled ventilation with a tidal volume of 6-8 ml/kg predicted body weight. PEEP titration was performed in eligible patients.

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: FCV Group1 intervention
Group B: VCV Group1 intervention

Trial outcomes

Primary outcomes

1

Intraoperative Respiratory Mechanics

Comparison of driving pressure between FCV and VCV groups at defined intraoperative time points.

Time frame
From intubation to end of surgery, measured after intubation, after insufflation, and at 30-minute intervals intraoperatively
2

Mean Arterial Pressure

Comparison of mean arterial pressure (MAP) between FCV and VCV groups at defined intraoperative time points.

Time frame
From preoperative baseline to end of surgery, measured before surgery, after intubation, after insufflation, at 30-minute intervals intraoperatively, and at end of surgery

Secondary outcomes

1

Pa02/Fi02 ratio

Comparison of Horowitz index between FCV and VCV groups.

Time frame
From intubation to end of surgery, measured after intubation, after insufflation, at 30-minute intervals intraoperatively and at the end of the surgery.
2

Postoperative Oxygen Theraphy Need

Comparison of percentage of participants requiring postoperative oxygen therapy requirement between FCV and VCV groups.

Time frame
Within 24 hours after surgery
3

Postoperative Intensive Unit Admission

Comparison of the number of patients requiring admission to the intensive care unit between the FCV and VCV groups.

Time frame
Within 24 hours after surgery
4

Arterial Partial Pressure of Carbon Dioxide (PaCO2)

Comparison of arterial partial pressure of carbon dioxide (PaCO2) between the FCV and VCV groups to evaluate efficiency of carbon dioxide elimination at defined time points.

Time frame
From intubation to the end of surgery, measured after intubation, after insufflation, and at 30-minute intervals intraoperatively and at the end of the operation

Other outcomes

Sponsors and contacts

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