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Intrinsic PEEP During Mechanical Ventilation of Patients With Obesity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Won Ho Kim, Seoul Medical Center
ClinicalTrials.gov Identifier:
NCT01267916
First received: December 28, 2010
Last updated: January 29, 2012
Last verified: January 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Official Title: Intrinsic PEEP During Mechanical Ventilation of Patients With Obesity. Influence of Low Respiratory Rate With Unchanged Minute Volume.

Resource links provided by NLM:


Further study details as provided by Seoul Medical Center:

Primary Outcome Measures:
  • Gas change parameters [ Time Frame: 15 minute interval ] [ Designated as safety issue: No ]
    PaO2 and PaCO2 the result of arterial blood gas analysis


Secondary Outcome Measures:
  • intrinsic positive end-expiratory pressure [ Time Frame: every 15 minutes ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267916

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

No publications provided

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
Study First Received: December 28, 2010
Last Updated: January 29, 2012
Health Authority: Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 24, 2014