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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
Laparoscopic surgery is associated with significant physiological changes due to pneumoperitoneum, which adversely affects hemodynamic and respiratory parameters, thereby complicating intraoperative anesthetic management. These challenges are particularly pronounced in obese patients, who present with reduced functional residual capacity and other physiological alterations that impact both intraoperative and postoperative outcomes.
Although bariatric surgery has conventionally been managed with volume-controlled ventilation (VCV), recent studies have highlighted the potential benefits of flow-controlled ventilation (FCV) in terms of safety and contribution to lung-protective ventilation strategies.
This study primarily aims to compare the effects of FCV and VCV on intraoperative hemodynamic and respiratory function dynamics in patients undergoing bariatric surgery. Secondarily, the study evaluates the clinical feasibility and safety of FCV under the high intraabdominal pressures and position changes required during bariatric procedures.
Study Design:
This study includes 34 patients with BMI >40 kg/m² classified as ASA I-III scheduled for elective laparoscopic bariatric surgery. Seventeen patients were prospectively managed with FCV, while data from 17 patients managed with VCV were retrospectively reviewed. All patients received standard monitoring plus intra-arterial blood pressure monitoring. Anesthesia induction and maintenance protocols were identical across both groups.
Ventilation Protocol:
In the FCV group, a tidal volume (VT) of 6-8 ml/kg predicted body weight was targeted, and positive end-expiratory pressure (PEEP) was individualized based on compliance following COâ‚‚ insufflation. The same tidal volume strategy was applied in the VCV group with PEEP titration performed in eligible patients.
Measurements:
The following parameters were recorded after intubation, after insufflation, and at 30-minute intervals intraoperatively: mean arterial pressure (MAP), heart rate, peripheral oxygen saturation (SpOâ‚‚), plateau airway pressure (Pplat), peak airway pressure (Ppeak), driving pressure, end-tidal COâ‚‚ (EtCOâ‚‚), minute volume, respiratory rate (RR), airway resistance (Raw), and static compliance (Cstatic) calculated as VT/(Pplat-PEEP). Arterial blood gas parameters including pH, PaCOâ‚‚, PaOâ‚‚, SaOâ‚‚, hemoglobin, and lactate were also recorded. Postoperative oxygen therapy requirement and intensive care unit admission were monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FCV Group | Patients undergoing elective laparoscopic bariatric surgery managed with flow-controlled ventilation (FCV) with tidal volume of 6-8 ml/kg predicted body weight and individualized PEEP based on compliance following COâ‚‚ insufflation. |
| |
| VCV Group | Patients undergoing elective laparoscopic bariatric surgery managed with volume-controlled ventilation (VCV) with tidal volume of 6-8 ml/kg predicted body weight and PEEP titration performed in eligible patients. Data collected retrospectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 COâ‚‚ insufflation. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Respiratory Mechanics | Comparison of driving pressure between FCV and VCV groups at defined intraoperative time points. | From intubation to end of surgery, measured after intubation, after insufflation, and at 30-minute intervals intraoperatively |
| Mean Arterial Pressure | Comparison of mean arterial pressure (MAP) between FCV and VCV groups at defined intraoperative time points. | From preoperative baseline to end of surgery, measured before surgery, after intubation, after insufflation, at 30-minute intervals intraoperatively, and at end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pa02/Fi02 ratio | Comparison of Horowitz index between FCV and VCV groups. | From intubation to end of surgery, measured after intubation, after insufflation, at 30-minute intervals intraoperatively and at the end of the surgery. |
| Postoperative Oxygen Theraphy Need |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tugce Ozdogan, MD | Contact | +90 5353588818 | tugceeskin@yahoo.com.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Education and Research Hospital | Recruiting | Ankara | 06230 | Turkey (Türkiye) |
Individual participant data will be shared upon reasonable request.
Beginning 6 months after publication and ending 5 years following article publication
Individual participant data will be available upon reasonable request to the corresponding author.
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|
| 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. |
|
Comparison of percentage of participants requiring postoperative oxygen therapy requirement between FCV and VCV groups. |
| Within 24 hours after surgery |
| Postoperative Intensive Unit Admission | Comparison of the number of patients requiring admission to the intensive care unit between the FCV and VCV groups. | Within 24 hours after surgery |
| 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. | 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 |
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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