Status:
COMPLETED
Assessing Air Travel Safety in Neuromuscular Dystrophy: Standard Versus Prolonged High Altitude Simulation Tests
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Neuromuscular Diseases
High Altitude Hypoxia
Eligibility:
All Genders
5+ years
Phase:
NA
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 ...
Detailed Description
Study Procedures Patients were screened for eligibility during a regularly scheduled clinic visit in which spirometry was performed in accordance with the American Thoracic Society recommendations.4 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03312361
Start Date
April 1 2016
End Date
April 1 2018
Last Update
August 19 2021
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8