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Endotracheal Tube Intracuff Pressure and Leak Around the Cuff During Retractor Placement for Adenotonsillectomy

NCT ID: NCT02640248

Last Updated: 2021-10-22

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2020-12-31

Brief Summary

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The investigators have devised a simple method to continuously measure the CP using an invasive pressure monitoring setup (IPMS), which is used routinely in the operating room to monitor arterial or central venous pressures. The investigators have previously confirmed both in vitro and in vivo (previous IRB approved protocol), a clinically applicable agreement of the IPMS readings with the values obtained from a standard manometer (gold standard). In the current study, we will prospectively evaluate the relationship between the patient's head position and CP in patients undergoing otolaryngological surgery and also measure the oxygen concentration in the oropharynx to determine the potential risk of an airway fire.

Detailed Description

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Conditions

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Otolaryngological Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cuff ETT

Cuff ETT

Intervention Type DEVICE

Interventions

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Cuff ETT

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Less than 18 years of age, 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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kris Jatana

OTHER

Sponsor Role lead

Responsible Party

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Kris Jatana

Ears Nose Throat Surgeon

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB15-00902

Identifier Type: -

Identifier Source: org_study_id