Accuracy of Using the CPAP Technique to Eliminate Air Lea... | NCT01384318

Studies
Accuracy of Using the CPAP Technique to Eliminate Air Leak and Prevent Excessive Endotracheal Tube Cuff Pressures

NCT01384318

Sponsor

Nationwide Children's Hospital

Status

Completed

Last Update Posted

Nov 30, 2012Estimated

Enrollment

200Actual

Phase

Not provided

Conditions

Surgical Patients Intubated With Cuffed ETT

Interventions

Manometer

Countries

United States

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

Nov 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

Jun 2011

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Jun 27, 2011

First Submission Date that Met QC Criteria

Jun 27, 2011

First Posted Date

Jun 29, 2011Estimated

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

Nov 29, 2012

Last Update Posted Date

Nov 30, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Joseph D. Tobias, Chairman Dept. of Anesthesiology & Pain Medicine, Nationwide Children's HospitalPrincipal Investigator

Lead Sponsor

Nationwide Children's HospitalOTHER

Collaborators

Not provided

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

In common clinical practice, one means of ensuring an acceptable cuff pressure in endotracheal tubes (ETT) is to hold continuous positive airway pressure (CPAP) of 20-25 cmH2O and inflate the cuff of the ETT until no gas leak is noted around the cuff. The purpose of this study is to validate this technique by checking the intracuff pressure using a manometer after the cuff is inflated using the CPAP technique.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cuffed ETT		Patients intubated with cuffed endotracheal tubes.	Other: Manometer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Manometer	Other	Measuring cuff pressure	Cuffed ETT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cuff pressure	cm H2O measured by manometer	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Having a cuffed ETT placed per treating anesthesiologist
< 18 yrs of age.

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

17 Years

Standard Ages

Child

Study Population

Patients intubated with cuffed ETTs.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph D Tobias, MD	Nationwide Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nationwide Children's Hospital		Columbus	Ohio	43205	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20560884	Background	Eschertzhuber S, Salgo B, Schmitz A, Roth W, Frotzler A, Keller CH, Gerber AC, Weiss M. Cuffed endotracheal tubes in children reduce sevoflurane and medical gas consumption and related costs. Acta Anaesthesiol Scand. 2010 Aug;54(7):855-8. doi: 10.1111/j.1399-6576.2010.02261.x. Epub 2010 Jun 15.
19887533	Background