Hypoxia, AltitudeNCT03976986
Assessment of Portable Oxygen Concentrators in Infants Undergoing Hypoxic Challenge Testing.
A study testing continuous-flow portable oxygen concentrator (cPOC) and pulsed-flow portable oxygen concentrator (pPOC) in people with Hypoxia, Altitude, run by Hospital Son Espases at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Hypoxia, Altitude
- What is being tested?
- continuous-flow portable oxygen concentrator (cPOC) and pulsed-flow portable oxygen concentrator (pPOC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 11 Feb 2016to 4 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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%.
Who cannot join
- acute respiratory infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypoxia, Altitude
- Being tested
- continuous-flow portable oxygen concentrator (cPOC), pulsed-flow portable oxygen concentrator (pPOC)
- Keywords
- Infants, Hypoxia Altitude Simulation Test, Oxygen Delivery Device, Portable Oxygen Concentrator, Hypoxic Challenge Testing
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| cPOC - pPOC | Experimental | 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). Receives: Device: continuous-flow portable oxygen concentrator (cPOC); Device: pulsed-flow portable oxygen concentrator (pPOC) |
| pPOC - cPOC | Experimental | 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). Receives: Device: continuous-flow portable oxygen concentrator (cPOC); Device: pulsed-flow portable oxygen concentrator (pPOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 minutes
Secondary outcomes (3)
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.
Measured: 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®
Measured: 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®
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start11 Feb 2016
- Primary completion4 Feb 2019
- Study completion4 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hypoxia, AltitudeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Son Espases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Sailer, Hospital Son Espases
- Investigators
- Sebastian Sailer, MD, Principal investigator, Hospital Son Espases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976986
- Sponsor's protocol ID
- cop2016
- Status last verified
- Jun 2019
- First submitted
- 31 May 2019
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 21856702Gong 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.
PubMed 6508019Blakeman 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.
PubMed 25945551Fischer 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.
PubMed 23085214Bunel 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.
PubMed 27959667Chen 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.
PubMed 30696754
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Portable Oxygen Concentrators in Infants Undergoing Hypoxic Challenge Testing. A Randomized Crossover Study.
- ClinicalTrials.gov ID
- NCT03976986
- Acronym / sponsor ID
- cop2016
- Conditions
- Hypoxia, Altitude
- Keywords
- Infants, Hypoxia Altitude Simulation Test, Oxygen Delivery Device, Portable Oxygen Concentrator, Hypoxic Challenge Testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hospital Son EspasesUniversity, hospital or other
- Study start
- 11 Feb 2016 (actual)
- Primary completion
- 4 Feb 2019 (actual)
- Study completion
- 4 Feb 2019 (actual)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cPOC - pPOC | Experimental | Device: continuous-flow portable oxygen concentrator (cPOC), Device: pulsed-flow portable oxygen concentrator (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). |
| pPOC - cPOC | Experimental | Device: continuous-flow portable oxygen concentrator (cPOC), Device: pulsed-flow portable oxygen concentrator (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 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). |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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%.
Key exclusion criteria (1 listed)
- acute respiratory infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous-flow portable oxygen concentrator (cPOC)SeQal Eclipse 3® on continuous-flow (SeQual,Ball Ground,GA): flow rate 2 litre per minute (lpm). | Device | cPOC - pPOC, pPOC - cPOC |
| 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). | Device | cPOC - pPOC, pPOC - cPOC |
Primary outcome
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.
3 secondary outcomes
POC comparison to change HCT induced hypoxia (Sat.O2 drop ≤ 85%).
Time frame: 20 minutes
Relate patient age (months) to POCs capacity to change HCT induced hypoxia (Sat.O2 drop ≤ 85%).
Time frame: 20 minutes
Relate patient weight (kilograms) to POCs capacity to change HCT induced hypoxia (Sat.O2 drop ≤ 85%).
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Results publication: PubMed 21856702Ahmedzai 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.
- Results publication: PubMed 6508019Gong 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.
- Results publication: PubMed 25945551Blakeman 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.
- Results publication: PubMed 23085214Fischer 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.
- Results publication: PubMed 27959667Bunel 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.
- Results publication: PubMed 30696754Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Sailer, MD principal investigator
Hospital Son Espases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous-flow portable oxygen concentrator (cPOC) and pulsed-flow portable oxygen concentrator (pPOC) in people with Hypoxia, Altitude, run by Hospital Son Espases at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of portable oxygen concentrators (POCs) to change HCT induced hypoxia (Sat.O2 drop ≤ 85%). (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03976986, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.