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OpenTrials
Completed

NCT Number: NCT01267916

Intrinsic PEEP During Mechanical Ventilation of Patients With Obesity

It is demonstrated that expiratory flow limitation and as a consequence, intrinsic positive end-expiratory pressure (PEEP) is present in grossly obese subjects especially in the supine position. The investigators tried to investigate the effect of low respiratory rate and high tidal volume on the intrinsic PEEP and gas exchange for obese subjects undergoing general anesthesia.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul Medical Center

Seoul, 135-740, South Korea

About this study

Impaired gas exchange is a common anesthetic problem in obese subjects. It is demonstrated that expiratory flow limitation and as a consequence, intrinsic positive end-expiratory pressure (PEEPi) is present in grossly obese subjects especially in the supine position. It is known that there is a significant negative correlation between PEEPi present and PaO2. Therefore, the investigators postulated that if the reduce the PEEPi by reducing the respiratory rate in obese subjects, the impaired gas exchange might improve.

The investigators tried to research the effect of low respiratory rate and high tidal volume on the intrinsic PEEP and gas exchange for obese subjects undergoing general anesthesia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA class I or II obesity, Body-mass index > 27.5 undergoing laparoscopic cholecystectomy

Exclusion criteria

  • patients with severe cardiopulmonary disease peak inspiratory pressure > 40 in the study setting

Treatment and study plan

RR 6 + 0

Device

Respiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 0

Other names: Ventilator setting

RR 10 + 0

Device

Respiratory rate 10 Tidal volume 10 ml/kg external PEEP = 0

Other names: Ventilator setting

RR 16 + 0

Device

Respiratory rate 16 Tidal volume 6.25 ml/kg external PEEP = 0

Other names: Ventilator setting

RR 6 + 5

Device

Respiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 5

Other names: Ventilator setting

RR 10 + 5

Device

Respiratory rate 10 Tidal volume 10 ml/kg external PEEP = 5

Other names: Ventilator setting

RR 16 + 5

Device

Respiratory rate 16 Tidal volume 6.25 ml/kg external PEEP = 5

Other names: Ventilator setting

Primary outcomes

  1. Gas change parameters

    Time frame: 15 minute interval

    PaO2 and PaCO2 the result of arterial blood gas analysis

Secondary outcomes

  1. intrinsic positive end-expiratory pressure

    Time frame: every 15 minutes

    PEEPi measured by expiratory port occlusion method

Sponsors and collaborators

Lead sponsor

Seoul Medical Center

Other

Registry information

Official study title

Intrinsic PEEP During Mechanical Ventilation of Patients With Obesity. Influence of Low Respiratory Rate With Unchanged Minute Volume.

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 29, 2010
Registry last updated
Jan 31, 2012

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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