Fitness to fly testing in children with type II respiratory failure V1
Research type
Research Study
Full title
Fitness to fly testing in children with neuromuscular disease or central hypoventilation: a feasibility study
IRAS ID
250547
Contact name
Martin Samuels
Contact email
Sponsor organisation
Great Ormond Street NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
‘Fitness-to-fly’ screening is based upon the hypoxic challenge test (HCT). During conventional HCTs patients breathe a reduced oxygen partial pressure, equivalent to conditions in aircraft cabins; they are monitored using pulse oximetry (SpO2). The conventional HCT identifies individuals whose SpO2 drops below 90%, and assesses whether supplemental oxygen corrects this. This is currently the gold standard but we believe we can improve on this.
The HCT was developed for chronic lung disease. Current guidance offers few recommendations for breathing problems not primarily related to lung disease. There is no guidance about assessing ventilation adequacy or carbon dioxide clearance. Supplemental oxygen can be associated with hypercarbia and acidosis in those at risk of type II respiratory failure. Conventional HCTs fail to identify children at risk of hypercarbia during flight and might leave some children vulnerable, particularly those with reduced respiratory muscle strength or respiratory drive. These children may need additional in-flight ventilatory support (non-invasive or via tracheostomy).
Our study will include a proof of concept component to explore changes in SpO2 and carbon dioxide levels in children with neuromuscular weakness or central hypoventilation under hypoxic conditions and with supplemental oxygen. We will also test the feasibility of a modified HCT in this population. We will test whether, in addition to monitoring SpO2, it is possible to monitor ventilatory sufficiency using transcutaneous (TcCO2) and end-tidal carbon dioxide (ETcCO2), and to assess the response to ventilatory support. We will assess acceptability of the modified-HCT and survey patients’ beliefs about the likely impact of improved fitness-to-fly testing upon decisions around travel. This study will allow us to refine the modified HCT in preparation for a larger study to determine whether ventilatory support during flights (to clear carbon dioxide and raise SpO2), rather than just supplemental oxygen, should be recommended for children with neuromuscular weakness/central hypoventilation.
REC name
London - South East Research Ethics Committee
REC reference
19/LO/0068
Date of REC Opinion
25 Jan 2019
REC opinion
Favourable Opinion