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

NHS Foundation Trust

Status: Completed

Conditions: Neuromuscular Diseases; Central Hypoventilation

Treatments: Diagnostic Test: Hypoxic challenge test

Study type: Interventional

Funder types: Other

Identifiers

NCT03824223

17IA16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: Under 18 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

new/old HCT component order

Other group

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.

Treatment:

Diagnostic Test: Hypoxic challenge test

old/new HCT component order

Other group

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.

Treatment:

Diagnostic Test: Hypoxic challenge test