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

Comparison of Volume Controlled Ventilation and Pressure Controlled Ventilation in Terms of Respiratory Mechanics in Laparoscopic Bariatric Surgery

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.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery
• Intervention / Treatment: Procedure: volume-controlled ventilation; Procedure: pressure-controlled ventilation

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey
    • Antalya Traning and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: volume-controlled ventilation group; 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.	Procedure: volume-controlled ventilation
ACTIVE_COMPARATOR: pressure-controlled ventilation group; 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.	Procedure: pressure-controlled ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Partial oxygen pressure	Assessed 5 minutes after induction by using arterial blood gas analysis.	5 minutes after induction
Partial oxygen pressure	Assessed 30 minutes after pneumoperitoneum by using arterial blood gas	30 minutes after pneumoperitoneum
Partial oxygen pressure	Assessed through surgery completion, an average of 90 minutes by using arterial blood gas	through surgery completion, an average of 90 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Partial carbon dioxide pressure	Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes by using arterial blood gas analysis.	5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
Partial carbon dioxide pressure - end-tidal carbon dioxide pressure	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.	5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
Peak airway pressure	Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes by using the patient monitor.	5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
Dynamic compliance	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)	5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
Inspired oxygen pressure / Fractional oxygen ratio	Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes	5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
Alveolar-arterial oxygen gradient pressure	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).	5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes

Collaborators and Investigators

• Sponsor: Antalya Training and Research Hospital
• Investigators: Study Director: Erhan Ozyurt, MD, Antalya Training And Research Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2016
• Primary Completion (ACTUAL): April 1, 2017
• Study Completion (ACTUAL): August 1, 2017

Study Registration Dates

• First Submitted: November 27, 2018
• First Submitted That Met QC Criteria: November 28, 2018
• First Posted (ACTUAL): November 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 29, 2018
• Last Update Submitted That Met QC Criteria: November 28, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: bariatric surgery; pressure-controlled ventilation; volume-controlled ventilation
• Other Study ID Numbers: AntalyaTRH31

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No