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Modified Endotracheal Balloon Dilator to Improve Patient Oxygenation and Allow Ventilation During Airway Procedures

NCT ID: NCT02796326

Last Updated: 2017-10-30

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

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-09-30

Brief Summary

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The purpose of the study is to prospectively assess the use of a modified tracheal balloon dilator that allows gas flow (oxygenation and ventilation) through the device while inflated during dilatation.

Detailed Description

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The primary aim is to determine the incidence of, and time to, arterial desaturation (defined as peripheral plethysmography below 90%). Secondary aims include quantitative and qualitative (waveform) end-tidal capnography levels throughout the procedure, quantitative assessment of dilatation, and incidence of adverse events.

Conditions

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Tracheal Stenosis

Keywords

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tracheal stenosis tracheal dilatation ventilation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dilatation

Patients undergoing tracheal dilatation with the study device

Group Type EXPERIMENTAL

improved tracheal balloon dilatation

Intervention Type DEVICE

Treatment for laryngotracheal stenosis using a modified tracheal dilatation balloon

Interventions

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improved tracheal balloon dilatation

Treatment for laryngotracheal stenosis using a modified tracheal dilatation balloon

Intervention Type DEVICE

Other Intervention Names

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tracheal balloon dilatation

Eligibility Criteria

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Inclusion Criteria

* Age \>18 years
* Symptoms of tracheal or laryngeal stenosis or airway narrowing
* Endoscopic evidence of subglottic or tracheal stenosis
* Able to provide informed consent

Exclusion Criteria

* Refractory stenosis not amenable to balloon dilatation
* Contraindication to balloon dilatation
* Lack of informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cape Town

OTHER

Sponsor Role lead

Responsible Party

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Ross Hofmeyr

Consultant Anaesthesiologist and Clinical Research Fellow in Airway and Thoracic Anaesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Groote Schuur Hospital

Cape Town, Western Cape, South Africa

Site Status

Countries

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South Africa

Other Identifiers

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UCTAnaes-2016-01

Identifier Type: -

Identifier Source: org_study_id