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

Sponsor

Hospital Son Espases (Other)

Overall Status

Completed

CT.gov ID

NCT03976986

Collaborator

(none)

Enrollment

Location

Arms

35.8

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypoxia, Altitude	Device: continuous-flow portable oxygen concentrator (cPOC) Device: pulsed-flow portable oxygen concentrator (pPOC)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 11, 2016

Actual Primary Completion Date :

Feb 4, 2019

Actual Study Completion Date :

Feb 4, 2019

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Assessment of portable oxygen concentrators (POCs) to change HCT induced hypoxia (Sat.O2 drop ≤ 85%). [20 minutes]
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.

Secondary Outcome Measures

POC comparison to change HCT induced hypoxia (Sat.O2 drop ≤ 85%). [20 minutes]
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.
Relate patient age (months) to POCs capacity to change HCT induced hypoxia (Sat.O2 drop ≤ 85%). [20 minutes]
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®
Relate patient weight (kilograms) to POCs capacity to change HCT induced hypoxia (Sat.O2 drop ≤ 85%). [20 minutes]
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®

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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%.