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

Hypoxia, Altitude Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03976986
• Other study ID #: cop2016
• Status: Completed
• Phase: N/A
• Start date: February 11, 2016
• Est. completion date: February 4, 2019

Study information

• Verified date: June 2019
• Source: Hospital Son Espases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 4, 2019
• Est. primary completion date: February 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Altitude Sickness
• Hypoxia
• Hypoxia, Altitude

Intervention

Device:
• continuous-flow portable oxygen concentrator (cPOC)
SeQal Eclipse 3® on continuous-flow (SeQual,Ball Ground,GA): flow rate 2 litre per minute (lpm).
• 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).

Locations

Country	Name	City	State
Spain	Hospital Son Espases	Palma Mallorca	Mallorca

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Son Espases

Country where clinical trial is conducted

Spain, 

References & 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; Brit — View Citation

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 — View Citation

Bunel V, Shoukri A, Choin F, Roblin S, Smith C, Similowski T, Morélot-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 — View Citation

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/ — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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