Intrinsic PEEP During Mechanical Ventilation of Patients With Obesity
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 28, 2010
CompletedFirst Posted
Study publicly available on registry
December 29, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJanuary 31, 2012
January 1, 2012
11 months
December 28, 2010
January 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gas change parameters
PaO2 and PaCO2 the result of arterial blood gas analysis
15 minute interval
Secondary Outcomes (1)
intrinsic positive end-expiratory pressure
every 15 minutes
Study Arms (6)
RR 6 + 0
EXPERIMENTALRespiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 0
RR 10 + 0
EXPERIMENTALRespiratory rate 10 Tidal volume 10 ml/kg external PEEP = 0
RR 16 + 0
EXPERIMENTALRespiratory rate 16 Tidal volume 6.25 ml/kg external PEEP = 0
RR 6 + 5
EXPERIMENTALRespiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 5
RR 10 + 5
EXPERIMENTALRespiratory rate 10 Tidal volume 10 ml/kg external PEEP = 5
RR 16 + 5
EXPERIMENTALRespiratory rate 16 Tidal volume 6.25 ml/kg external PEEP = 5
Interventions
Respiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 0
Respiratory rate 10 Tidal volume 10 ml/kg external PEEP = 0
Respiratory rate 16 Tidal volume 6.25 ml/kg external PEEP = 0
Respiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 5
Respiratory rate 10 Tidal volume 10 ml/kg external PEEP = 5
Respiratory rate 16 Tidal volume 6.25 ml/kg external PEEP = 5
Eligibility Criteria
You may qualify if:
- ASA class I or II obesity, Body-mass index \> 27.5 undergoing laparoscopic cholecystectomy
You may not qualify if:
- patients with severe cardiopulmonary disease peak inspiratory pressure \> 40 in the study setting
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul Medical Center
Seoul, 135-740, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Anesthesiologist
Study Record Dates
First Submitted
December 28, 2010
First Posted
December 29, 2010
Study Start
January 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
January 31, 2012
Record last verified: 2012-01