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Symptomatic Treatment of Excessive Dynamic Airway Collapse Using Daytime Portable Continuous Positive Airway Pressure

NCT02763631 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2018-05-29

No results posted yet for this study

Summary

The aim of this study is to assess the benefit of a portable ventilator generating positive end-expiratory pressure on exercise tolerance in patients with Excessive dynamic airway collapse (EDAC) and tracheobronchomalacia (TBM).

Conditions

  • Excessive Dynamic Airway Collapse
  • Tracheobronchomalacia

Interventions

OTHER

Experimental: Treatment

Participants will be established on portable CPAP during the day with nasal pillows as an interface and requested to use it at least 8 hours/day.

OTHER

Experimental: Run In Phase

Participants will undergo a run-in phase during which they will undergo baseline assessments. If they tolerate the portable CPAP and if their 6-MWT improves by more than 30m when performed on CPAP, they will be randomised into the trial.

OTHER

Sham Comparator: Stand Care Arm

No change will be made to participants care

Sponsors & Collaborators

  • B&D Electromedical

    collaborator INDUSTRY

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Nick Hart · Guy's and St Thomas' NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-06-14
Completion
2017-06-14

Countries

  • United Kingdom

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 NCT02763631 on ClinicalTrials.gov