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

October 27, 2017 updated by: Ross Hofmeyr, University of Cape Town
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7925
        • Groote Schuur Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dilatation
Patients undergoing tracheal dilatation with the study device
Device: improved tracheal balloon dilatation
Treatment for laryngotracheal stenosis using a modified tracheal dilatation balloon
Other Names:
  • tracheal balloon dilatation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of peripheral arterial desaturation
Time Frame: During procedure (up to 60 minutes duration)
Incidence of desaturation below 90% as measured by peripheral pulse oximeter
During procedure (up to 60 minutes duration)
Time to desaturation
Time Frame: During procedure (up to 60 minutes duration)
Time to desaturation below 90% as measured by peripheral pulse oximeter
During procedure (up to 60 minutes duration)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of tracheal dilatation by comparison of pre- and post-dilatation Myer-Cotton grading
Time Frame: During procedure (up to 60 minutes duration)
Describes the stenosis based on the percent relative reduction in cross-sectional area of the subglottis. Four grades of stenosis: grade I lesions have less than 50% obstruction, grade II lesions have 51% to 70% obstruction, grade III lesions have 71% to 99% obstruction, grade IV lesions have no detectable lumen or complete stenosis.
During procedure (up to 60 minutes duration)
Incidence of major adverse events
Time Frame: During and within 24 hours of procedure
During and within 24 hours of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cape Town

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

September 30, 2017

Study Registration Dates

First Submitted

June 1, 2016

First Submitted That Met QC Criteria

June 6, 2016

First Posted (Estimate)

June 10, 2016

Study Record Updates

Last Update Posted (Actual)

October 30, 2017

Last Update Submitted That Met QC Criteria

October 27, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCTAnaes-2016-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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