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

NCT ID: NCT01384318

Last Updated: 2012-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-05-31

Brief Summary

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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

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Conditions

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Surgical Patients Intubated With Cuffed ETT

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cuffed ETT

Patients intubated with cuffed endotracheal tubes.

Manometer

Intervention Type OTHER

Measuring cuff pressure

Interventions

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Manometer

Measuring cuff pressure

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joseph D. Tobias

Chairman Dept. of Anesthesiology & Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph D Tobias, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20560884 (View on PubMed)

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. doi: 10.1093/bja/aep290. Epub 2009 Nov 3.

Reference Type BACKGROUND
PMID: 19887533 (View on PubMed)

Weiss M, Dullenkopf A. Cuffed tracheal tubes in children: past, present and future. Expert Rev Med Devices. 2007 Jan;4(1):73-82. doi: 10.1586/17434440.4.1.73.

Reference Type BACKGROUND
PMID: 17187473 (View on PubMed)

Other Identifiers

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IRB11-00414

Identifier Type: -

Identifier Source: org_study_id