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Completed

NCT Number: NCT03976986

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

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.

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Key information

Conditions

Hypoxia, Altitude Altitude Sickness Respiration Disorders Respiratory Tract Diseases

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Son Espases

Palma Mallorca, Mallorca, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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®

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

    Time frame: 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®

Sponsors and collaborators

Lead sponsor

Hospital Son Espases

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 6, 2019
Registry last updated
Jun 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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