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Endotracheal Dilator to Improve Oxygenation (EDITION2)

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: NCT03411928
Recruitment Status : Unknown
Verified May 2018 by Ross Hofmeyr, University of Cape Town.
Recruitment status was:  Not yet recruiting
First Posted : January 26, 2018
Last Update Posted : May 2, 2018
Sponsor:
Collaborator:
Red Cross War Memorial Children's Hospital
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 in children (<13 years old) with subglottic or tracheal stenosis. The hypothesis is that the device will effectively dilate the stenotic segment, whilst maintaining oxygenation (if applicable). The primary aim is to measure the stenosis prior to, and after dilatation; using diameter and the modified Myer-Cotton grading system. Secondary aims include assessment of stenosis at six-week follow-up and monitoring arterial oxygenation nadir (using peripheral plethysmography) during the procedure.

Condition or disease Intervention/treatment Phase
Tracheal Stenosis Airway Disease Pediatric Respiratory Diseases Device: Tracheolator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective interventional study
Masking: None (Open Label)
Masking Description: Unblinded
Primary Purpose: Treatment
Official Title: Modified Endotracheal Balloon Dilator to Improve Oxygenation During Airway Procedures in Children With Tracheal Stenosis
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Arm Intervention/treatment
Experimental: Tracheolator
Tracheal dilatation using the study device as per the protocol.
Device: Tracheolator
'Tracheolator' non-occlusive tracheal dilation balloon manufactured by Disa Life Sciences, Cape Town, South Africa.




Primary Outcome Measures :
  1. Change in internal tracheal stenosis diameter [ Time Frame: Immediate ]
    Post-dilation change from pre-dilatation values, measured using Myer-Cotton grade and millimeter value


Secondary Outcome Measures :
  1. Peripheral arterial oxygenation [ Time Frame: Immediate ]
    Oxygen saturation nadir as determined by plethysmography

  2. Change in internal tracheal stenosis diameter [ Time Frame: 6 weeks post dilatation ]
    Change from pre- and post-dilatation values, measured using Myer-Cotton grade and millimeter value



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.


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Ages Eligible for Study:   up to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Refractory stenosis not amenable to balloon dilatation
  • Contraindication to balloon dilatation (long-segment stenosis)
  • Patient refusal

Exclusion Criteria:

  • Refractory stenosis not amenable to balloon dilatation
  • Contraindication to balloon dilatation (long-segment stenosis)
  • Patient refusal

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): NCT03411928


Contacts
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Contact: Jessica McGuire, FCORL +27722072991 jessica.mcguire@uct.ac.za
Contact: Ross Hofmeyr, FCA(SA) +27845499259 ross.hofmeyr@uct.ac.za

Locations
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South Africa
Groote Schuur Hospital
Cape Town, Western Cape, South Africa, 7925
Contact: Ross Hofmeyr, FCA(SA)    +27214045003    ross.hofmeyr@uct.ac.za   
Sub-Investigator: Reuben Smith, MBChB         
Sponsors and Collaborators
University of Cape Town
Red Cross War Memorial Children's Hospital
Investigators
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Principal Investigator: Ross Hofmeyr, FCA(SA) University of Cape Town
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Responsible Party: Ross Hofmeyr, Associate Professor, Dept Anaesthesia & Perioperative Medicine, University of Cape Town
ClinicalTrials.gov Identifier: NCT03411928    
Other Study ID Numbers: UCT_ENT_Anaes_201801
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The data set will be published after study completion using a medium still to be determined. Data set will be available to other researchers on request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiration Disorders
Tracheal Stenosis
Constriction, Pathologic
Respiratory Tract Diseases
Pathological Conditions, Anatomical
Tracheal Diseases