Modes of Ventilation During Laparoscopic Bariatric Surgery

Completed

• Conditions: Bariatric Surgery
• Interventions: Other: Pressure controlled ventilation; Other: Volume controlled ventilation; Other: PRVC ventilation

• Registration Number: NCT01890564
• Lead Sponsor: Joseph D. Tobias

Brief Summary

During minimally invasive surgery, a pneumoperitoneum is created to facilitate surgical visualization. Although effective in facilitating the procedure, there are respiratory consequences of the pneumoperitoneum, which significantly increases intra-abdominal pressure (IAP) up to 20 cmH2O. The increased IAP can decrease functional residual capacity and increase closing capacity resulting in increased resistance, decreased compliance, and increased ventilation-perfusion mismatch. In a randomized, cross-over design, this study will evaluate in sequential order, 3 modes of ventilation during laparoscopic bariatric surgery to determine which is better able to support oxygenation and ventilation while limiting the peak inflating pressure (PIP).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-27
• Study First Submitted QC: 2013-06-27
• Study First Posted: 2013-07-02
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-31
• Last Update Posted: 2014-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Laparoscopic bariatric surgery requiring intra-arterial blood pressure monitoring, age 14-20 years.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bariatric surgery	Pressure controlled ventilation	Patients undergoing bariatric surgery.
Bariatric surgery	Volume controlled ventilation	Patients undergoing bariatric surgery.
Bariatric surgery	PRVC ventilation	Patients undergoing bariatric surgery.

Primary Outcome Measures

Name	Time	Method
Change in heart rate	Baseline to 30 mins.	Heart rate will be assessed every 5 mins. during each 30 minute mode of ventilation.

Secondary Outcome Measures

Name	Time	Method
Change in blood pressure	Baseline to 30 mins.	Blood pressure will be recorded every 5 mins. during each 30 minute mode of ventilation.
Blood gas	30 mins.	Blood gas will be obtained at the end of each 30 minute mode of ventilation.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States