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

Hospital Son Espases

Status: Completed

Conditions: Hypoxia, Altitude

Treatments: Device: continuous-flow portable oxygen concentrator (cPOC); Device: pulsed-flow portable oxygen concentrator (pPOC)

Study type: Interventional

Funder types: Other

Identifiers

NCT03976986

cop2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: Under 16 years old

Volunteers: No 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%.

Exclusion criteria

• acute respiratory infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

cPOC - pPOC

Experimental group

Description:

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).

Treatment:

Device: pulsed-flow portable oxygen concentrator (pPOC)

Device: continuous-flow portable oxygen concentrator (cPOC)

pPOC - cPOC

Experimental group

Description:

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).

Treatment:

Device: pulsed-flow portable oxygen concentrator (pPOC)

Device: continuous-flow portable oxygen concentrator (cPOC)