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

Not Applicable

Completed

• Conditions: Central Hypoventilation; Neuromuscular Diseases
• Interventions: Diagnostic Test: Hypoxic challenge test

• Registration Number: NCT03824223
• Lead Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-01-31
• Study Start: 2019-02-01
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-07
• Last Update Posted: 2021-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
new/old HCT component order	Hypoxic challenge test	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 HCT component order	Hypoxic challenge test	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Feasibility outcome 1: recruitment rate	one year	recruitment rate
Feasibility outcome 2: protocol completion rate	one year	protocol completion rate

Trial Locations

Locations (1)

Great Ormond Street Hospital for Children NHS Foundation Trust; 🇬🇧 London, United Kingdom