An interventional study of continuous-flow portable oxygen concentrator (cPOC) and pulsed-flow portable oxygen concentrator (pPOC) in Hypoxia, Altitude, sponsored by Hospital Son Espases. Completed at 1 site in Spain. Open to participants aged Up to 16 Years. Per ClinicalTrials.gov, last updated 2019-06-06.
Sponsored by Hospital Son Espases · Not applicable, Interventional, and Treatment
Hypoxic Challenge Testing (HCT) is the recommended method for inflight hypoxia risk assessment. Onboard oxygen administration remains controversial. The Federal Aviation Administration approved portable oxygen concentrators (POCs) for onboard oxygen supply but there is lack of evidence about the use, especially in children. The aim of our study is to establish the effectiveness and safety of POCs in infants undergoing HCT.
According to a forecast by International Air Transport Association the number of people travelling on commercial aircrafts is predicted to rise up to 8.2 billion passengers in 2037. Therefore evidence-based flight recommendations will gain importance in the future, especially for patients suffering from chronic diseases. Hypoxic Challenge Testing (HCT) is the recommended method for inflight hypoxia risk assessment where nitrogen is introduced in a plethysmograph reducing FiO2 (fraction of inspired oxygen) to 0.15. Oxygen supply is recommended if PaO2 (partial pressure of oxygen in arterial blood) drops \<50-55 mmHg (in adults) or Sat.O2 (oxygen saturation) ≤ 85% (in infants) where non-invasive pulse oximetry is the recommended method for hypoxia assessment. Onboard oxygen administration remains controversial. The effectiveness of pulsed-dosed systems remains unclear in small patients due to shallow breathing patterns. The aim of our study is to establish the effectiveness and safety of POCs in infants undergoing HCT.
189 studies on the registry are indexed under Altitude Sickness; 44 are open to participants now.
This study's enrollment of 26 is below the median of 33 across 157 interventional studies indexed under Altitude Sickness.
Browse Altitude Sickness studies →Hospital Son Espases is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with baseline Sat.O2 >94% AND
Exclusion Criteria:
Randomized crossover study (according to a random number table): Patients are allocated randomly to two study groups (cPOC/pPOC). In case of Sat.O2 drop ≤ 85% during HCT, oxygen is administered by cPOC (continuous-flow). For patients who show a positive POC hypoxic reversal, HCT is repeated at 24 hours and oxygen is administered by pPOC (pulsed-flow).
Device: continuous-flow portable oxygen concentrator (cPOC) · Device: pulsed-flow portable oxygen concentrator (pPOC)
Randomized crossover study (according to a random number table): Patients are allocated randomly to two study groups (cPOC/pPOC). In case of Sat.O2 drop ≤ 85% during HCT, oxygen is administered by pPOC (pulsed-flow). For patients who show a positive POC hypoxic reversal, HCT is repeated at 24 hours and oxygen is administered by cPOC (continuous-flow).
Device: continuous-flow portable oxygen concentrator (cPOC) · Device: pulsed-flow portable oxygen concentrator (pPOC)
SeQal Eclipse 3® on continuous-flow (SeQual,Ball Ground,GA): flow rate 2 litre per minute (lpm).
InogenOne G3® (Inogen,Goleta,CA) on pulsed-flow mode: setting 2 (flow rate 420 ml/min, 16.8 ml +/- 3ml per bolus at 25 rpm).
Assessment of portable oxygen concentrators (POCs) to change HCT induced hypoxia (Sat.O2 drop ≤ 85%).
Hypoxia (Sat.O2 drop ≤ 85%) measured by Masimo SET Radical-7 Electron® pulse oximeter is induced performing HCT. Thereafter oxygen is administered through cPOC or pPOC until baseline Sat.O2 (Sat.O2 \>93%) is achieved.
Time frame: 20 minutes
POC comparison to change HCT induced hypoxia (Sat.O2 drop ≤ 85%).
Compare the capacity of different POCs: continuous flow (cPOC) versus pulsed flow (pPOC) to change HCT induced hypoxia (Sat.O2 ≤ 85%) until baseline Sat.O2 (Sat.O2 \>93%) is achieved.
Time frame: 20 minutes
Relate patient age (months) to POCs capacity to change HCT induced hypoxia (Sat.O2 drop ≤ 85%).
Relationship between patient age (months) and POCs capacity to change hypoxic state (≤ 85%) to baseline Sat.O2 (\>93%) measured by Masimo SET Radical-7 Electron®
Time frame: 20 minutes
Relate patient weight (kilograms) to POCs capacity to change HCT induced hypoxia (Sat.O2 drop ≤ 85%).
Relationship between patient weight (kilograms) and POCs capacity to change hypoxic state (≤ 85%) to baseline Sat.O2 (\>93%) measured by Masimo SET Radical-7 Electron®
Time frame: 20 minutes
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Hospital Son Espases