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NCT Number: NCT03824223

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

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.

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Key information

Conditions

Neuromuscular Diseases Central Hypoventilation Nervous System Diseases

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Great Ormond Street Hospital for Children NHS Foundation Trust

London, WC1N 3JH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypoxic challenge test

Diagnostic Test

Physiological response to 15% ambient oxygen monitored.

Primary outcomes

  1. proof of concept outcome 1

    Time frame: during hypoxic challenge test

    number of children/infants with SpO2 <90/85%

  2. proof of concept outcome 2

    Time frame: during hypoxic challenge test

    number of children with >15 mmHg rise in TcCO2/EtCO2

Secondary outcomes

  1. Feasibility outcome 1: recruitment rate

    Time frame: one year

    recruitment rate

  2. Feasibility outcome 2: protocol completion rate

    Time frame: one year

    protocol completion rate

Sponsors and collaborators

Lead sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Other

Collaborators

  • University College, London

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 31, 2019
Registry last updated
Dec 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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