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Intrinsic PEEP During Mechanical Ventilation of Patients With Obesity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01267916
First Posted: December 29, 2010
Last Update Posted: January 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Won Ho Kim, Seoul Medical Center
  Purpose
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.

Condition Intervention
General Anesthesia Laparoscopic Cholecystectomy Device: RR 6 + 0 Device: RR 10 + 0 Device: RR 16 + 0 Device: RR 6 + 5 Device: RR 10 + 5 Device: RR 16 + 5

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Official Title: Intrinsic PEEP During Mechanical Ventilation of Patients With Obesity. Influence of Low Respiratory Rate With Unchanged Minute Volume.

Further study details as provided by Won Ho Kim, Seoul Medical Center:

Primary Outcome Measures:
  • Gas change parameters [ Time Frame: 15 minute interval ]
    PaO2 and PaCO2 the result of arterial blood gas analysis


Secondary Outcome Measures:
  • intrinsic positive end-expiratory pressure [ Time Frame: every 15 minutes ]
    PEEPi measured by expiratory port occlusion method


Enrollment: 20
Study Start Date: January 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Ventilator setting

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01267916


Locations
Korea, Republic of
Seoul Medical Center
Seoul, Korea, Republic of, 135-740
Sponsors and Collaborators
Seoul Medical Center
  More Information

Responsible Party: Won Ho Kim, Staff Anesthesiologist, Seoul Medical Center
ClinicalTrials.gov Identifier: NCT01267916     History of Changes
Other Study ID Numbers: SMC-2010-12-13
First Submitted: December 28, 2010
First Posted: December 29, 2010
Last Update Posted: January 31, 2012
Last Verified: January 2012

Keywords provided by Won Ho Kim, Seoul Medical Center:
intrinsic positive end-expiratory pressure
obesity
ventilator setting
respiratory rate

Additional relevant MeSH terms:
Obesity
Positive-Pressure Respiration, Intrinsic
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases


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