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

NHS Foundation Trust logo

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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