'Fitness To Fly' Tests In Children With Type II Respiratory Failure

Neuromuscular Diseases Clinical Trial

Official title:

'Fitness To Fly' Testing In Children With Neuromuscular Weakness Or Central Hypoventilation: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03824223
• Other study ID #: 17IA16
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: December 2021
• Source: Great Ormond Street Hospital for Children NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Hypoventilation
• Hypoventilation
• Neuromuscular Diseases

Intervention

Diagnostic Test:
• Hypoxic challenge test
Physiological response to 15% ambient oxygen monitored.

Locations

Country	Name	City	State
United Kingdom	Great Ormond Street Hospital for Children NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Great Ormond Street Hospital for Children NHS Foundation Trust	University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proof of concept outcome 1	number of children/infants with SpO2 <90/85%	during hypoxic challenge test
Primary	proof of concept outcome 2	number of children with >15 mmHg rise in TcCO2/EtCO2	during hypoxic challenge test
Secondary	Feasibility outcome 1: recruitment rate	recruitment rate	one year
Secondary	Feasibility outcome 2: protocol completion rate	protocol completion rate	one year