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Endotracheal Dilator to Improve Oxygenation

NCT03411928 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-05-02

No results posted yet for this study

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.

Conditions

  • Tracheal Stenosis
  • Airway Disease
  • Pediatric Respiratory Diseases

Interventions

DEVICE

Tracheolator

'Tracheolator' non-occlusive tracheal dilation balloon manufactured by Disa Life Sciences, Cape Town, South Africa.

Sponsors & Collaborators

  • Red Cross War Memorial Children's Hospital

    collaborator UNKNOWN

  • University of Cape Town

    lead OTHER

Principal Investigators

  • Ross Hofmeyr, FCA(SA) · University of Cape Town

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2018-12-30
Completion
2018-12-30

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03411928 on ClinicalTrials.gov