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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Joseph D. Tobias, Nationwide Children's Hospital

ClinicalTrials.gov Identifier:

NCT01384318

First received: June 27, 2011

Last updated: November 29, 2012

Last verified: November 2012

History of Changes

Purpose

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.

Condition	Intervention
Surgical Patients Intubated With Cuffed ETT	Other: Manometer

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective

Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:

Cuff pressure [ Time Frame: Baseline ] [ Designated as safety issue: No ]
cm H2O measured by manometer

Enrollment:	200
Study Start Date:	June 2011
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Cuffed ETT Patients intubated with cuffed endotracheal tubes.	Other: Manometer Measuring cuff pressure

Eligibility

Ages Eligible for Study:	up to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients intubated with cuffed ETTs.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01384318

Locations

United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205

Sponsors and Collaborators

Nationwide Children's Hospital

Investigators

Principal Investigator:

Joseph D Tobias, MD

Nationwide Children's Hospital

More Information

Publications:

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. Epub 2010 Jun 15.

Weiss M, Dullenkopf A, Fischer JE, Keller C, Gerber AC; European Paediatric Endotracheal Intubation Study Group. Prospective randomized controlled multi-centre trial of cuffed or uncuffed endotracheal tubes in small children. Br J Anaesth. 2009 Dec;103(6):867-73. Epub 2009 Nov 3.

Weiss M, Dullenkopf A. Cuffed tracheal tubes in children: past, present and future. Expert Rev Med Devices. 2007 Jan;4(1):73-82. Review.

Responsible Party:	Joseph D. Tobias, Chairman Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:	NCT01384318 History of Changes
Other Study ID Numbers:	IRB11-00414
Study First Received:	June 27, 2011
Last Updated:	November 29, 2012
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2013

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