Intrinsic PEEP During Mechanical Ventilation of Patients With Obesity

January 29, 2012 updated by: Won Ho Kim, Seoul Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RR 6 + 0
Respiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 0
Device: RR 6 + 0
Respiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 0
Other Names:
  • Ventilator setting
Experimental: RR 10 + 0
Respiratory rate 10 Tidal volume 10 ml/kg external PEEP = 0
Device: RR 10 + 0
Respiratory rate 10 Tidal volume 10 ml/kg external PEEP = 0
Other Names:
  • Ventilator setting
Experimental: RR 16 + 0
Respiratory rate 16 Tidal volume 6.25 ml/kg external PEEP = 0
Device: RR 16 + 0
Respiratory rate 16 Tidal volume 6.25 ml/kg external PEEP = 0
Other Names:
  • Ventilator setting
Experimental: RR 6 + 5
Respiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 5
Device: RR 6 + 5
Respiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 5
Other Names:
  • Ventilator setting
Experimental: RR 10 + 5
Respiratory rate 10 Tidal volume 10 ml/kg external PEEP = 5
Device: RR 10 + 5
Respiratory rate 10 Tidal volume 10 ml/kg external PEEP = 5
Other Names:
  • Ventilator setting
Experimental: RR 16 + 5
Respiratory rate 16 Tidal volume 6.25 ml/kg external PEEP = 5
Device: RR 16 + 5
Respiratory rate 16 Tidal volume 6.25 ml/kg external PEEP = 5
Other Names:
  • Ventilator setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gas change parameters
Time Frame: 15 minute interval
PaO2 and PaCO2 the result of arterial blood gas analysis
15 minute interval

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intrinsic positive end-expiratory pressure
Time Frame: every 15 minutes
PEEPi measured by expiratory port occlusion method
every 15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

December 28, 2010

First Submitted That Met QC Criteria

December 28, 2010

First Posted (Estimate)

December 29, 2010

Study Record Updates

Last Update Posted (Estimate)

January 31, 2012

Last Update Submitted That Met QC Criteria

January 29, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC-2010-12-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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