CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
continuous-flow portable oxygen concentrator (cPOC) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03976986
NCT03976986N/ACompleted
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Assessment of Portable Oxygen Concentrators in Infants Undergoing Hypoxic Challenge Testing. A Randomized Crossover Study.

Hospital Son Espases·interventional·Posted Jun 6, 2019·Updated Jun 6, 2019

In Brief

A clinical study evaluating continuous-flow portable oxygen concentrator (cPOC) and pulsed-flow portable oxygen concentrator (pPOC) for Hypoxia, Altitude. Completed, enrolled 26 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypoxia, Altitude
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 6, 2019
Enrollment StartFeb 11, 2016
Primary CompletionFeb 4, 2019
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 7.1 years ago

Interventions

continuous-flow portable oxygen concentrator (cPOC)device

SeQal Eclipse 3® on continuous-flow (SeQual,Ball Ground,GA): flow rate 2 litre per minute (lpm).

pulsed-flow portable oxygen concentrator (pPOC)device

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).