Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02796326
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : October 30, 2017
Sponsor:
Information provided by (Responsible Party):
Ross Hofmeyr, University of Cape Town

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tracheal Stenosis Device: improved tracheal balloon dilatation Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Modified Endotracheal Balloon Dilator to Improve Patient Oxygenation and Allow Ventilation During Airway Procedures
Actual Study Start Date : October 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

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 Name: tracheal balloon dilatation




Primary Outcome Measures :
  1. 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

  2. Time to desaturation [ Time Frame: During procedure (up to 60 minutes duration) ]
    Time to desaturation below 90% as measured by peripheral pulse oximeter


Secondary Outcome Measures :
  1. 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.

  2. Incidence of major adverse events [ Time Frame: During and within 24 hours of procedure ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796326


Locations
Layout table for location information
South Africa
Groote Schuur Hospital
Cape Town, Western Cape, South Africa, 7925
Sponsors and Collaborators
University of Cape Town

Layout table for additonal information
Responsible Party: Ross Hofmeyr, Consultant Anaesthesiologist and Clinical Research Fellow in Airway and Thoracic Anaesthesia, University of Cape Town
ClinicalTrials.gov Identifier: NCT02796326     History of Changes
Other Study ID Numbers: UCTAnaes-2016-01
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ross Hofmeyr, University of Cape Town:
tracheal stenosis
tracheal dilatation
ventilation

Additional relevant MeSH terms:
Layout table for MeSH terms
Tracheal Stenosis
Tracheal Diseases
Respiratory Tract Diseases