The Relationship Between Patients' Head Position and ETT Intracuff Pressure

NCT ID: NCT01851317

Last Updated: 2023-12-13

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

2013-04-30

Study Completion Date

2014-04-30

Brief Summary

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This study is designed to investigate the relationship between patients' position and endotracheal tube intracuff pressure in the pediatric population.

Detailed Description

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There are currently no data in the literature as to the effect of changes in head position on CP. As the cuff is located in the patients' trachea, the shape of the patents' trachea may be change depending on the position of the patient's head and therefore, the CP may also change. If the intracuff pressure will increase as the patient's head is moved into a flexed or extended position, these patients may be at risk for tracheal damage. The investigators will prospectively evaluate the relationship between the patient's head position and CP in patients undergoing otolaryngological surgery.

Conditions

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Patients Undergoing ENT Surgery With Cuffed ETT

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intracuff pressure

Procedure/Surgery: Cuffed endotracheal tube

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age less than 18 years
* Undergoing otolaryngological surgery with endotracheal intubation

Exclusion Criteria

* Patient who is intubated with an uncuffed endotracheal tube
* Patients who have a limitation for movement of the neck or concerns of the stability of the cervical spine
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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Responsibility Role SPONSOR

Principal Investigators

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Hiromi Kako, M.D.

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

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Nationwide Children's

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB13-00243

Identifier Type: -

Identifier Source: org_study_id