Cuff Pressure in Patients: Manometer vs Invasive Pressure Monitoring Setup

NCT ID: NCT01885793

Last Updated: 2017-01-31

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

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-12-31

Brief Summary

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This is a prospective study looking at ways to measure the cuff pressure of cuffed endotracheal tubes (ETTs). We will be comparing a hand-held manometer (MM) to the transducer of an invasive pressure monitoring setup (IPMS), which is commonly used for arterial or central venous pressure monitoring. The investigators previously did this study in vivo with ETTs in polyvinyl chloride (PVC) "tracheas" and we found that there is good correlation between the pressure readings using the MM and the IPMS. The purpose of the current study is to validate the in vitro findings in clinical situations.

Detailed Description

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Conditions

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Anesthesia Intubation Complication

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Cuffed endotracheal tube

Surgical patients who require endotracheal intubation with a cuffed endotracheal tube (ETT).

Cuffed endotracheal tube

Intervention Type DEVICE

Intubation with a cuffed endotracheal tube (ETT).

Interventions

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Cuffed endotracheal tube

Intubation with a cuffed endotracheal tube (ETT).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Intubation of trachea with a cuffed endotracheal tube.

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Senthil G. Krishna

OTHER

Sponsor Role lead

Responsible Party

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Senthil G. Krishna

Assistant Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Senthil Gopalakrishnan, 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

Other Identifiers

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IRB13-00107

Identifier Type: -

Identifier Source: org_study_id

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