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Intrinsic PEEP During Mechanical Ventilation of Patients With Obesity

NCT ID: NCT01267916

Last Updated: 2012-01-31

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

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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General Anesthesia Laparoscopic Cholecystectomy

Keywords

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intrinsic positive end-expiratory pressure obesity ventilator setting respiratory rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Caregivers

Study Groups

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RR 6 + 0

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

Group Type EXPERIMENTAL

RR 6 + 0

Intervention Type DEVICE

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

RR 10 + 0

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

Group Type EXPERIMENTAL

RR 10 + 0

Intervention Type DEVICE

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

RR 16 + 0

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

Group Type EXPERIMENTAL

RR 16 + 0

Intervention Type DEVICE

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

RR 6 + 5

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

Group Type EXPERIMENTAL

RR 6 + 5

Intervention Type DEVICE

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

RR 10 + 5

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

Group Type EXPERIMENTAL

RR 10 + 5

Intervention Type DEVICE

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

RR 16 + 5

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

Group Type EXPERIMENTAL

RR 16 + 5

Intervention Type DEVICE

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

Interventions

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RR 6 + 0

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

Intervention Type DEVICE

RR 10 + 0

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

Intervention Type DEVICE

RR 16 + 0

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

Intervention Type DEVICE

RR 6 + 5

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

Intervention Type DEVICE

RR 10 + 5

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

Intervention Type DEVICE

RR 16 + 5

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

Intervention Type DEVICE

Other Intervention Names

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Ventilator setting Ventilator setting Ventilator setting Ventilator setting Ventilator setting Ventilator setting

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Won Ho Kim

Staff Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SMC-2010-12-13

Identifier Type: -

Identifier Source: org_study_id