Comparison of Volume Controlled Ventilation and Pressure Controlled Ventilation in Laparoscopic Bariatric Surgery

Not Applicable

Completed

• Conditions: Bariatric Surgery
• Interventions: Procedure: volume-controlled ventilation; Procedure: pressure-controlled ventilation

• Registration Number: NCT03758937
• Lead Sponsor: Antalya Training and Research Hospital

Brief Summary

The purpose of this study is to compare volume controlled-ventilation (VCV) and pressure-controlled ventilation (PCV) in terms of pulmonary gas exchange, respiratory mechanics and arterial blood gas values in patients undergoing laparoscopic bariatric surgery.

Detailed Description

Today, morbid obesity has become a global problem. It is not clear which mechanical ventilation mode will be used in bariatric surgery, which is one of the treatment options of these patients. VCV is the most commonly used mode to ventilate anesthetized patients. However, especially in obese patients, high airway pressures and hypoxia may occur due to increased intrapulmonary shunts. Therefore, we aimed to investigate the potential of PCV strategy to improve pulmonary gas exchange, respiratory mechanics and arterial blood gas values according to VCV in patients undergoing bariatric surgery.

Study Timeline

• Study Start: 2016-04-01
• Primary Completion: 2017-04-01
• Study Completion: 2017-08-01
• Status Verified: 2018-11
• Study First Submitted: 2018-11-27
• Study First Submitted QC: 2018-11-28
• Last Update Submitted: 2018-11-28
• Study First Posted: 2018-11-29
• Last Update Posted: 2018-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• 18 years or above,
• ASA II patients
• BMI > 40 kg / m2
• No serious comorbidity.

Exclusion Criteria

• Unstable patients during the operation
• The requirement for mechanical ventilation in the postoperative period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
volume-controlled ventilation group	volume-controlled ventilation	During the operation, necessary interventions were made by following the algorithm. Hemodynamic and mechanical ventilation parameters of patients were recorded 5 minutes after induction, 30 minutes after pneumoperitoneum and at the end of surgery and were performed arterial blood gas analysis.
pressure-controlled ventilation group	pressure-controlled ventilation	During the operation, necessary interventions were made by following the algorithm. Hemodynamic and mechanical ventilation parameters of patients were recorded 5 minutes after induction, 30 minutes after pneumoperitoneum and at the end of surgery and were performed arterial blood gas analysis.

Primary Outcome Measures

Name	Time	Method
Partial oxygen pressure	through surgery completion, an average of 90 minutes	Assessed through surgery completion, an average of 90 minutes by using arterial blood gas

Secondary Outcome Measures

Name	Time	Method
Peak airway pressure	5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes	Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes by using the patient monitor.
Dynamic compliance	5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes	Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes by using formula (Tidal volume/peak airway pressure - Positive end-expiratory pressure)
Inspired oxygen pressure / Fractional oxygen ratio	5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes	Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes
Alveolar-arterial oxygen gradient pressure	5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes	Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes by using formula (D(A-a) O2).
Partial carbon dioxide pressure	5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes	Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes by using arterial blood gas analysis.
Partial carbon dioxide pressure - end-tidal carbon dioxide pressure	5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes	Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes by using arterial blood gas analysis and end-tidal monitor.

Trial Locations

Locations (1)

Antalya Traning and Research Hospital; 🇹🇷 Antalya, Turkey