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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03824223

Enrollment

Registered

2019-01-31

Start date

2019-02-01

Completion date

2021-08-31

Last updated

2021-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Hypoventilation, Neuromuscular Diseases

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.

Interventions

DIAGNOSTIC_TESTHypoxic challenge test

Physiological response to 15% ambient oxygen monitored.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Intervention model description

Participants randomised to uniform balanced crossover (new/old or old/new hypoxic challenge test components).

Eligibility

Sex/Gender

ALL

Age

0 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
proof of concept outcome 1	during hypoxic challenge test	number of children/infants with SpO2 \<90/85%
proof of concept outcome 2	during hypoxic challenge test	number of children with \>15 mmHg rise in TcCO2/EtCO2

Secondary

Measure	Time frame	Description
Feasibility outcome 1: recruitment rate	one year	recruitment rate
Feasibility outcome 2: protocol completion rate	one year	protocol completion rate

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026