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| Name | Class |
|---|---|
| University College, London | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| new/old HCT component order | Other | 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 | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypoxic challenge test | Diagnostic Test | Physiological response to 15% ambient oxygen monitored. |
|
| Measure | Description | Time Frame |
|---|---|---|
| proof of concept outcome 1 | number of children/infants with SpO2 <90/85% | during hypoxic challenge test |
| proof of concept outcome 2 | number of children with >15 mmHg rise in TcCO2/EtCO2 | during hypoxic challenge test |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility outcome 1: recruitment rate | recruitment rate | one year |
| Feasibility outcome 2: protocol completion rate | protocol completion rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katharine C Pike, PhD | Great Ormond Street Hospital for Children NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Great Ormond Street Hospital for Children NHS Foundation Trust | London | WC1N 3JH | United Kingdom |
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| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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Participants randomised to uniform balanced crossover (new/old or old/new hypoxic challenge test components).
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| one year |