Intrinsic PEEP During Mechanical Ventilation of Patients... | NCT01267916

Studies
Intrinsic PEEP During Mechanical Ventilation of Patients With Obesity

NCT01267916

Sponsor

Seoul Medical Center

Status

Completed

Last Update Posted

Jan 31, 2012Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

General Anesthesia
Laparoscopic Cholecystectomy

Interventions

RR 6 + 0
RR 10 + 0
RR 16 + 0
RR 6 + 5
RR 10 + 5
RR 16 + 5

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Dec 28, 2010

First Submission Date that Met QC Criteria

Dec 28, 2010

First Posted Date

Dec 29, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2012

Last Update Posted Date

Jan 31, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RR 6 + 0	Experimental	Respiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 0	Device: RR 6 + 0
RR 10 + 0	Experimental	Respiratory rate 10 Tidal volume 10 ml/kg external PEEP = 0	Device: RR 10 + 0
RR 16 + 0	Experimental	Respiratory rate 16 Tidal volume 6.25 ml/kg external PEEP = 0	Device: RR 16 + 0
RR 6 + 5	Experimental	Respiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 5	Device: RR 6 + 5
RR 10 + 5	Experimental	Respiratory rate 10 Tidal volume 10 ml/kg external PEEP = 5	Device: RR 10 + 5
RR 16 + 5	Experimental	Respiratory rate 16 Tidal volume 6.25 ml/kg external PEEP = 5

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RR 6 + 0	Device	Respiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 0	RR 6 + 0

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul Medical Center		Seoul		135-740	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided