Endotracheal Dilator to Improve Oxygenation (EDITION2)
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|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
|Condition or disease||Intervention/treatment||Phase|
|Tracheal Stenosis Airway Disease Pediatric Respiratory Diseases||Device: Tracheolator||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective interventional study|
|Masking:||None (Open Label)|
|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|
Tracheal dilatation using the study device as per the protocol.
'Tracheolator' non-occlusive tracheal dilation balloon manufactured by Disa Life Sciences, Cape Town, South Africa.
- Change in internal tracheal stenosis diameter [ Time Frame: Immediate ]Post-dilation change from pre-dilatation values, measured using Myer-Cotton grade and millimeter value
- Peripheral arterial oxygenation [ Time Frame: Immediate ]Oxygen saturation nadir as determined by plethysmography
- 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
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
|Contact: Jessica McGuire, FCORLfirstname.lastname@example.org|
|Contact: Ross Hofmeyr, FCA(SA)||+email@example.com|
|Groote Schuur Hospital|
|Cape Town, Western Cape, South Africa, 7925|
|Contact: Ross Hofmeyr, FCA(SA) +27214045003 firstname.lastname@example.org|
|Sub-Investigator: Reuben Smith, MBChB|
|Principal Investigator:||Ross Hofmeyr, FCA(SA)||University of Cape Town|