Modes of Ventilation During Laparoscopic Bariatric Surgery
1 other identifier
observational
30
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 27, 2013
CompletedFirst Posted
Study publicly available on registry
July 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedApril 1, 2014
March 1, 2014
7 months
June 27, 2013
March 31, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change in heart rate
Heart rate will be assessed every 5 mins. during each 30 minute mode of ventilation.
Baseline to 30 mins.
Secondary Outcomes (2)
Change in blood pressure
Baseline to 30 mins.
Blood gas
30 mins.
Study Arms (1)
Bariatric surgery
Patients undergoing bariatric surgery.
Interventions
For pressure controlled ventilation, the peak inflating pressure (PIP) is set for each tidal breath.
For volume controlled ventilation, the tidal volume is set.
Pressure-regulated, volume-controlled (PRVC) is an auto-regulated pressure-controlled mode of mechanical ventilation with a user-selected tidal volume target.
Eligibility Criteria
Bariatric surgery patients
You may qualify if:
- Laparoscopic bariatric surgery requiring intra-arterial blood pressure monitoring, age 14-20 years.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Joseph D. Tobiaslead
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chairman - Dept. of Anesthesiology & Pain Medicine
Study Record Dates
First Submitted
June 27, 2013
First Posted
July 2, 2013
Study Start
June 1, 2013
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
April 1, 2014
Record last verified: 2014-03