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Assessment of Portable Oxygen Concentrators in Infants Undergoing Hypoxic Challenge Testing.

NCT03976986 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2019-06-06

No results posted yet for this study

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.

Conditions

  • Hypoxia, Altitude

Interventions

DEVICE

continuous-flow portable oxygen concentrator (cPOC)

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

DEVICE

pulsed-flow portable oxygen concentrator (pPOC)

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).

Sponsors & Collaborators

  • Hospital Son Espases

    lead OTHER

Principal Investigators

  • Sebastian Sailer, MD · Hospital Son Espases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-11
Primary Completion
2019-02-04
Completion
2019-02-04

Countries

  • Spain

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03976986 on ClinicalTrials.gov