Back to results'Fitness To Fly' Tests In Children With Type II Respiratory Failure
Primary Purpose
Neuromuscular Diseases, Central Hypoventilation
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Hypoxic challenge test
Sponsored by
About this trial
This is an interventional other trial for Neuromuscular Diseases
Eligibility Criteria
Inclusion Criteria:
- ≤18 years
- Neuromuscular weakness or central hypoventilation
- Established nocturnal or intermittent daytime ventilatory support
Exclusion Criteria:
- Unable to sit in the plethysmograph
- Cardiac anomaly with right-to-left shunt
Sites / Locations
- Great Ormond Street Hospital for Children NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
new/old HCT component order
old/new HCT component order
Arm Description
new/old hypoxic challenge test (HCT) component order Where the new test uses pulse oximetry and transcutaneous CO2 monitoring to guide use of ventilatory support and if necessary supplementary oxygen and the old test uses pulse oximetry to titrate supplementary oxygen.
old/new hypoxic challenge test (HCT) component order Where the old test uses pulse oximetry to titrate supplementary oxygen and the new test uses pulse oximetry and transcutaneous CO2 monitoring to guide use of ventilatory support and if necessary supplementary oxygen.
Outcomes
Primary Outcome Measures
proof of concept outcome 1
number of children/infants with SpO2 <90/85%
proof of concept outcome 2
number of children with >15 mmHg rise in TcCO2/EtCO2
Secondary Outcome Measures
Feasibility outcome 1: recruitment rate
recruitment rate
Feasibility outcome 2: protocol completion rate
protocol completion rate
Full Information
NCT ID
NCT03824223
First Posted
January 29, 2019
Last Updated
December 7, 2021
Sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborators
University College, London
1. Study Identification
Unique Protocol Identification Number
NCT03824223
Brief Title
'Fitness To Fly' Tests In Children With Type II Respiratory Failure
Official Title
'Fitness To Fly' Testing In Children With Neuromuscular Weakness Or Central Hypoventilation: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborators
University College, London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The conventional hypoxic challenge test might not predict 'fitness-to-fly' equally well in all patients. Patients at risk of hypercapnia with supplemental oxygen are not well studied. Th investigators will study children who have either neuromuscular weakness or central hypoventilation and who require nocturnal or intermittent daytime ventilator support.
The study also aims to assess feasibility of a randomised controlled trial (RCT) comparing the standard hypoxic standard test to a modified test designed to better suit children with type two respiratory failure.
Detailed Description
This study will assess feasibility of pulse oximetry (SpO2), end tidal carbon dioxide (ETCO2) and transcutaneous carbon dioxide partial pressure (TcCO2) measurement during a modified Hypoxic challenge test (HCT) in 12 children with neuromuscular weakness and 12 with central hypoventilation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Diseases, Central Hypoventilation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants randomised to uniform balanced crossover (new/old or old/new hypoxic challenge test components).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
new/old HCT component order
Arm Type
Other
Arm Description
new/old hypoxic challenge test (HCT) component order
Where the new test uses pulse oximetry and transcutaneous CO2 monitoring to guide use of ventilatory support and if necessary supplementary oxygen and the old test uses pulse oximetry to titrate supplementary oxygen.
Arm Title
old/new HCT component order
Arm Type
Other
Arm Description
old/new hypoxic challenge test (HCT) component order
Where the old test uses pulse oximetry to titrate supplementary oxygen and the new test uses pulse oximetry and transcutaneous CO2 monitoring to guide use of ventilatory support and if necessary supplementary oxygen.
Intervention Type
Diagnostic Test
Intervention Name(s)
Hypoxic challenge test
Intervention Description
Physiological response to 15% ambient oxygen monitored.
Primary Outcome Measure Information:
Title
proof of concept outcome 1
Description
number of children/infants with SpO2 <90/85%
Time Frame
during hypoxic challenge test
Title
proof of concept outcome 2
Description
number of children with >15 mmHg rise in TcCO2/EtCO2
Time Frame
during hypoxic challenge test
Secondary Outcome Measure Information:
Title
Feasibility outcome 1: recruitment rate
Description
recruitment rate
Time Frame
one year
Title
Feasibility outcome 2: protocol completion rate
Description
protocol completion rate
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≤18 years
Neuromuscular weakness or central hypoventilation
Established nocturnal or intermittent daytime ventilatory support
Exclusion Criteria:
Unable to sit in the plethysmograph
Cardiac anomaly with right-to-left shunt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katharine C Pike, PhD
Organizational Affiliation
Great Ormond Street Hospital for Children NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Great Ormond Street Hospital for Children NHS Foundation Trust
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
'Fitness To Fly' Tests In Children With Type II Respiratory Failure
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