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Completed

NCT Number: NCT02796326

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

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.

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Key information

Conditions

Tracheal Stenosis Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Tracheal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groote Schuur Hospital

Cape Town, Western Cape, 7925, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

improved tracheal balloon dilatation

Device

Treatment for laryngotracheal stenosis using a modified tracheal dilatation balloon

Other names: tracheal balloon dilatation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Cape Town

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 10, 2016
Registry last updated
Oct 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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