Assessing Air Travel Safety in Neuromuscular Dystrophy: Standard Versus Prolonged High Altitude Simulation Tests
1 other identifier
interventional
23
1 country
1
Brief Summary
To determine if a prolonged high altitude simulation test (HAST) lasting two hours, identifies more patients at risk of respiratory failure than the standard HAST lasting 20 minutes, in patients with neuromuscular disease (NMD) and severe pulmonary restriction. To evaluate the safety of supplemental oxygen administered in those with a positive HAST in the NMD population.
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 Apr 2016
Typical duration 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
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 12, 2017
CompletedFirst Posted
Study publicly available on registry
October 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedAugust 19, 2021
August 1, 2021
2 years
October 12, 2017
August 12, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Prolonged high altitude simulation test
To determine if a prolonged high altitude simulation test (HAST) lasting two hours, identifies more patients at risk of respiratory failure than the standard HAST lasting 20 minutes, in patients with NMD and severe pulmonary restriction
3 years
Secondary Outcomes (1)
Interventional high altitude simulation test
3 years
Study Arms (1)
15% Oxygen
EXPERIMENTALAll participants will breath in 15% oxygen for 2 hours
Interventions
Eligibility Criteria
You may qualify if:
- individuals with a confirmed diagnosis of NMD
- age ≥ 5 years of age
- absence of hypoxia at rest, defined as oxygen saturation ≥ 92% for two consecutive minutes while at rest and breathing room air
- absence of daytime hypercapnea at rest, defined by partial pressure of carbon dioxide (pCO2) less than 45 mmHg on capillary or arterial blood gas at rest
- patient or authorized substitute decision maker provides consent to study participation.
You may not qualify if:
- current respiratory tract infection
- inability to comply with the study procedures
- severe heart failure as defined by uncontrolled symptoms of heart failure, or left ventricular ejection fraction \< 30%
- presence of a tracheostomy
- use of domiciliary bilevel positive airway pressure (BPAP) for more than 12 hours daily
- recent hospital admission within the past 4 weeks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Respirologist
Study Record Dates
First Submitted
October 12, 2017
First Posted
October 17, 2017
Study Start
April 1, 2016
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
August 19, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share