NCT03976986

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 11, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
Last Updated

June 6, 2019

Status Verified

June 1, 2019

Enrollment Period

3 years

First QC Date

May 31, 2019

Last Update Submit

June 4, 2019

Conditions

Hypoxia, Altitude

Keywords

InfantsHypoxia Altitude Simulation TestOxygen Delivery DevicePortable Oxygen ConcentratorHypoxic Challenge Testing

Outcome Measures

Primary Outcomes (1)

  • 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.

    20 minutes

Secondary Outcomes (3)

  • POC comparison to change HCT induced hypoxia (Sat.O2 drop ≤ 85%).

    20 minutes

  • Relate patient age (months) to POCs capacity to change HCT induced hypoxia (Sat.O2 drop ≤ 85%).

    20 minutes

  • Relate patient weight (kilograms) to POCs capacity to change HCT induced hypoxia (Sat.O2 drop ≤ 85%).

    20 minutes

Study Arms (2)

cPOC - pPOC

EXPERIMENTAL

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)

pPOC - cPOC

EXPERIMENTAL

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)

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).

cPOC - pPOCpPOC - cPOC
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).

cPOC - pPOCpPOC - cPOC

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients with baseline Sat.O2 \>94% AND
  • \<1 year with neonatal respiratory disease
  • required oxygen supply in the last 6 months
  • chronic respiratory disease (eg cystic fibrosis, obstructive or restrictive pulmonary disease) with FEV 1 (forced expiratory volume in 1 second) or FVC (forced vital capacity) \<50%.

You may not qualify if:

  • acute respiratory infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Son Espases

Palma Mallorca, Mallorca, Spain

Location

Related Publications (6)

  • Ahmedzai S, Balfour-Lynn IM, Bewick T, Buchdahl R, Coker RK, Cummin AR, Gradwell DP, Howard L, Innes JA, Johnson AO, Lim E, Lim WS, McKinlay KP, Partridge MR, Popplestone M, Pozniak A, Robson A, Shovlin CL, Shrikrishna D, Simonds A, Tait P, Thomas M; British Thoracic Society Standards of Care Committee. Managing passengers with stable respiratory disease planning air travel: British Thoracic Society recommendations. Thorax. 2011 Sep;66 Suppl 1:i1-30. doi: 10.1136/thoraxjnl-2011-200295. No abstract available.

    PMID: 21856702RESULT

  • Gong H Jr, Tashkin DP, Lee EY, Simmons MS. Hypoxia-altitude simulation test. Evaluation of patients with chronic airway obstruction. Am Rev Respir Dis. 1984 Dec;130(6):980-6. doi: 10.1164/arrd.1984.130.6.980.

    PMID: 6508019RESULT

  • Blakeman TC, Rodriquez D Jr, Gerlach TW, Dorlac WC, Johannigman JA, Branson RD. Oxygen requirement to reverse altitude-induced hypoxemia with continuous flow and pulsed dose oxygen. Aerosp Med Hum Perform. 2015 Apr;86(4):351-6. doi: 10.3357/AMHP.4184.2015.

    PMID: 25945551RESULT

  • Fischer R, Wanka ER, Einhaeupl F, Voll K, Schiffl H, Lang SM, Gruss M, Ferrari U. Comparison of portable oxygen concentrators in a simulated airplane environment. Respir Med. 2013 Jan;107(1):147-9. doi: 10.1016/j.rmed.2012.10.001. Epub 2012 Oct 22.

    PMID: 23085214RESULT

  • Bunel V, Shoukri A, Choin F, Roblin S, Smith C, Similowski T, Morelot-Panzini C, Gonzalez J. Bench Evaluation of Four Portable Oxygen Concentrators Under Different Conditions Representing Altitudes of 2438, 4200, and 8000 m. High Alt Med Biol. 2016 Dec;17(4):370-374. doi: 10.1089/ham.2016.0056.

    PMID: 27959667RESULT

  • Chen JZ, Katz IM, Pichelin M, Zhu K, Caillibotte G, Finlay WH, Martin AR. In Vitro-In Silico Comparison of Pulsed Oxygen Delivery From Portable Oxygen Concentrators Versus Continuous Flow Oxygen Delivery. Respir Care. 2019 Feb;64(2):117-129. doi: 10.4187/respcare.06359. Epub 2019 Jan 29.

    PMID: 30696754RESULT

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Sebastian Sailer, MD

    Hospital Son Espases

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 31, 2019

First Posted

June 6, 2019

Study Start

February 11, 2016

Primary Completion

February 4, 2019

Study Completion

February 4, 2019

Last Updated

June 6, 2019

Record last verified: 2019-06

Locations

ES(1)