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

Assessment of Portable Oxygen Concentrators in Infants Undergoing Hypoxic Challenge Testing. A Randomized Crossover Study.

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 Overview

• Status: Completed
• Conditions: Hypoxia, Altitude
• Intervention / Treatment: Device: continuous-flow portable oxygen concentrator (cPOC); Device: pulsed-flow portable oxygen concentrator (pPOC)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Mallorca
    • Palma Mallorca, Mallorca, Spain
      • Hospital son Espases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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%.

Exclusion Criteria:

• acute respiratory infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: cPOC - 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 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); 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).
EXPERIMENTAL: pPOC - cPOC; 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); 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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®	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®	20 minutes

Collaborators and Investigators

• Sponsor: Hospital Son Espases
• Investigators: Principal Investigator: Sebastian Sailer, MD, Hospital son Espases

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 11, 2016
• Primary Completion (ACTUAL): February 4, 2019
• Study Completion (ACTUAL): February 4, 2019

Study Registration Dates

• First Submitted: May 31, 2019
• First Submitted That Met QC Criteria: June 4, 2019
• First Posted (ACTUAL): June 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 6, 2019
• Last Update Submitted That Met QC Criteria: June 4, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Infants; Portable Oxygen Concentrator; Hypoxia Altitude Simulation Test; Oxygen Delivery Device; Hypoxic Challenge Testing
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Altitude Sickness; Hypoxia
• Other Study ID Numbers: cop2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No