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OpenTrials
Completed

NCT Number: NCT01890564

Modes of Ventilation During Laparoscopic Bariatric Surgery

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).

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Key information

Conditions

Bariatric Surgery

Age range

14 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Pressure controlled ventilation

Other

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

Volume controlled ventilation

Other

For volume controlled ventilation, the tidal volume is set.

PRVC ventilation

Other

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

Primary outcomes

  1. Change in heart rate

    Time frame: Baseline to 30 mins.

    Heart rate will be assessed every 5 mins. during each 30 minute mode of ventilation.

Secondary outcomes

  1. Change in blood pressure

    Time frame: Baseline to 30 mins.

    Blood pressure will be recorded every 5 mins. during each 30 minute mode of ventilation.

  2. Blood gas

    Time frame: 30 mins.

    Blood gas will be obtained at the end of each 30 minute mode of ventilation.

Sponsors and collaborators

Lead sponsor

Joseph D. Tobias

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 2, 2013
Registry last updated
Apr 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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