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Modes of Ventilation During Laparoscopic Bariatric Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01890564
Enrollment
30
Registered
2013-07-02
Start date
2013-06-30
Completion date
2014-01-31
Last updated
2014-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery

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).

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.

Sponsors

Joseph D. Tobias
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Years to 20 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Change in heart rateBaseline to 30 mins.Heart rate will be assessed every 5 mins. during each 30 minute mode of ventilation.

Secondary

MeasureTime frameDescription
Change in blood pressureBaseline to 30 mins.Blood pressure will be recorded every 5 mins. during each 30 minute mode of ventilation.
Blood gas30 mins.Blood gas will be obtained at the end of each 30 minute mode of ventilation.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026