Modes of Ventilation During Laparoscopic Bariatric Surgery

NCT ID: NCT01890564

Last Updated: 2014-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-01-31

Brief Summary

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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

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Conditions

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Bariatric Surgery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Bariatric surgery

Patients undergoing bariatric surgery.

Pressure controlled ventilation

Intervention Type OTHER

For pressure controlled ventilation, the peak inflating pressure (PIP) is set for each tidal breath.

Volume controlled ventilation

Intervention Type OTHER

For volume controlled ventilation, the tidal volume is set.

PRVC ventilation

Intervention Type OTHER

Pressure-regulated, volume-controlled (PRVC) is an auto-regulated pressure-controlled mode of mechanical ventilation with a user-selected tidal volume target.

Interventions

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Pressure controlled ventilation

For pressure controlled ventilation, the peak inflating pressure (PIP) is set for each tidal breath.

Intervention Type OTHER

Volume controlled ventilation

For volume controlled ventilation, the tidal volume is set.

Intervention Type OTHER

PRVC ventilation

Pressure-regulated, volume-controlled (PRVC) is an auto-regulated pressure-controlled mode of mechanical ventilation with a user-selected tidal volume target.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

14 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Joseph D. Tobias

OTHER

Sponsor Role lead

Responsible Party

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Joseph D. Tobias

Chairman - Dept. of Anesthesiology & Pain Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB12-00783

Identifier Type: -

Identifier Source: org_study_id

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