Endotracheal Dilator to Improve Oxygenation
EDITION2
Modified Endotracheal Balloon Dilator to Improve Oxygenation During Airway Procedures in Children With Tracheal Stenosis
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2018
CompletedFirst Posted
Study publicly available on registry
January 26, 2018
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2018
CompletedMay 2, 2018
May 1, 2018
4 months
January 9, 2018
May 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change in internal tracheal stenosis diameter
Post-dilation change from pre-dilatation values, measured using Myer-Cotton grade and millimeter value
Immediate
Secondary Outcomes (2)
Peripheral arterial oxygenation
Immediate
Change in internal tracheal stenosis diameter
6 weeks post dilatation
Study Arms (1)
Tracheolator
EXPERIMENTALTracheal dilatation using the study device as per the protocol.
Interventions
'Tracheolator' non-occlusive tracheal dilation balloon manufactured by Disa Life Sciences, Cape Town, South Africa.
Eligibility Criteria
You may qualify if:
- Refractory stenosis not amenable to balloon dilatation
- Contraindication to balloon dilatation (long-segment stenosis)
- Patient refusal
You may not qualify if:
- Refractory stenosis not amenable to balloon dilatation
- Contraindication to balloon dilatation (long-segment stenosis)
- Patient refusal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Groote Schuur Hospital
Cape Town, Western Cape, 7925, South Africa
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ross Hofmeyr, FCA(SA)
University of Cape Town
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Unblinded
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Dept Anaesthesia & Perioperative Medicine
Study Record Dates
First Submitted
January 9, 2018
First Posted
January 26, 2018
Study Start
September 1, 2018
Primary Completion
December 30, 2018
Study Completion
December 30, 2018
Last Updated
May 2, 2018
Record last verified: 2018-05