Chronic Respiratory DiseaseNCT03728595
Validation of a Predictive Score for HAST
An observational study of Chronic Respiratory Disease and Hypoxia, Altitude, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Patients with chronic lung diseases travelling by plane often suffer with symptoms related to lower oxygen levels they are exposed to while flying. Therefore, patients with respiratory conditions are routinely assessed to establish if they need supplemental oxygen in flight. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Respiratory Disease, Hypoxia, Altitude, COPD
- What is being tested?
- Venepuncture, Spirometry and Hypoxic altitude simulation test (HAST)
- How many people
- 96 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Oct 2018to 31 Mar 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient attending for a HAST at Leeds Teaching Hospital NHS Trust.
Who may be able to join
- Age ≥18 years old (at the time of HAST)
- Clinically stable
- Hypoxic altitude simulation test, scheduled as part of the clinical care
Who cannot join
- Inability to provide informed consent
- Being part of a clinical trial, which would exclude patients who are taking part in other studies including observational studies.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St James's University Hospital, LTHT
Leeds, West Yorkshire, LS9 7TF
About this study
Official title: A Predictive Score to Reduce the Use of Hypoxic-altitude Simulation Test (HAST) in Patients With Chronic Respiratory Disease Planning Air Travel - an External Validation Prospective Study
Patients with chronic lung diseases travelling by plane often suffer with symptoms related to lower oxygen levels they are exposed to while flying.
Therefore, patients with respiratory conditions are routinely assessed to establish if they need supplemental oxygen in flight. A hypoxic altitude simulation test (HAST) is often part of this assessment and consists in having patients breathe a oxygen/nitrogen blend with a lower oxygen concentration compared to normal room air, simulating in-flight conditions. Oxygen levels are measured before and after the test through a blood sample (from the earlobe or an artery in the wrist) and with a finger probe. In-flight oxygen is required if the oxygen level in the blood is lower than 6.6 kPa. HASTs are time consuming, costly, and require a dedicated hospital appointment.
Read more
Using historical data, the Investigators developed scores based on capillary blood gas (blood sample from the earlobe), diagnosis and sex to predict the outcome of the HASTs. The Investigators validated the proposed scores in a separate historic cohort of patients and showed it had good concordance with the HASTs results.
In this study, the Investigators want to confirm prospectively if the score, based on blood results (venous and/or earlobe), can predict the outcome of the HASTs and therefore reduce the number of tests performed, travel time for patients, and costs for the NHS.
All patients, aged 18 or older, who are having a HAST for clinical purposes at the cardio-respiratory lab at Leeds Teaching Hospital NHS Trust will be invited to take part in the study. The Investigators will record diagnosis, results of HAST and previous spirometry from the medical notes, perform a spirometry if not done in the previous 12 months and collect a blood sample (one tube, 4 mls). With these data, the Investigators will calculate the score and assess its agreement with the outcome of the HAST.
Each participant's involvement in the study will last for approximately 90-120 minutes, which is the normal duration of a HAST.
The Investigators aim to include up to 280 subjects in the study.
Read the detailed description
Over the last two decades, there has been a significant increase in the number of people flying on a regular basis. As a result, more individuals with chronic respiratory disease are being referred for formal assessment to assess if they require inflight oxygen.
At cruising altitude, passengers are exposed to reduced atmospheric pressure equivalent to an altitude of 8000 ft, corresponding to a reduction of oxygen from 21% to approximately 15%. National and International recommendations on air travel suggest screening patients with chronic lung diseases for the need of in-flight oxygen supplementation. However, due to the paucity of available evidence, there is no consensus on which investigation should be performed and the precise risk factors associated with in-flight complications.
The British Thoracic Society, which published the most recent and comprehensive recommendations on this topic, recommends that patients with respiratory diseases should be assessed clinically, and in specific situations, a hypoxic altitude simulation tests (HAST) should be performed. Unfortunately, the vast majority of these recommendations are level C at best, as current evidence is limited to a handful of prospective or retrospective analyses.
A standard hypoxic altitude simulation test requires the patients to breathe a blend of 15% oxygen in nitrogen for 20 minutes. This simulates the oxygen tension at 8000 ft, the equivalent cabin pressure. Blood gas measurements are taken before and after the test. A fall in the pO2 below 6.6 kPa is considered indicative for use of in-flight oxygen.
Often the HASTs yield negative results (i.e. no inflight oxygen required). These tests are heavy on resources, time consuming, costly, not widely available and require dedicate hospital appointment. Thus, predictors of outcomes of HASTs are needed to reduce the number of HASTs performed.
Several studies have looked at predictors of oxygen desaturation during HAST in varying populations with the aim of better selecting patients who need the test. However, results have been inconclusive. Data on the role of baseline oxygenation, FEV1 and exercise test in predicting oxygen desaturation during the HAST are conflicting and most studies have been too small to provide decisive answers.
The Investigators recently developed and validate, on historical data, three scores to predict negative HASTs, according to the BTS 2011 recommendations (i.e. scores predicting which patients do not need to undergo a formal assessment). All of these had good ROC AUC and agreement with the outcome of the HAST in the retrospective dataset.
The Investigators hypothesise that the multivariable score (Model 1), based on a combination of CBG variables (bicarbonate and oxygen saturation) and baseline diagnosis (ILD and COPD) would be the best predictor of negative response in a formal HAST. Furthermore, the Investigator hypothesise that the score could be further simplified for the use in clinical practice by measuring the serum bicarbonate and oxygen saturation through a pulse oximeter (Model 1s). This is in light of the good arterio-venous concordance previously demonstrated for bicarbonate and of the good reliability of non-invasive measurement of oxygen saturation. Such a simplified score, if its predictive value is confirmed, would not only reduce the number of unnecessary HAST performed, but also minimise patients' discomfort and hospital appointments, reducing the costs for the NHS.
In this prospective single centre study, the Investigators will assess the validity of the best performing score (Model 1) derived in our retrospective study for negative HAST. In addition, the Investigators want to verify whether the use of SpO2 in place of SO2 and of serum bicarbonate in place of capHCO3 would allow for similar results. The investigators also aim to evaluate the performance of the other predictive scores previously derived in our retrospective analysis, and, if none of these models are a good and effective predictor, we aim to develop a new model based on newly measured data.
The Investigators aim to enroll up to 280 subjects, but interim analyses will be performed with the scope to early terminate the study if primary outcome is met.
Demographic and baseline characteristics of patients will be analysed on the whole population and by the cohorts depending on the underlying diagnosis and the outcome of the HAST.
Receiver operating characteristics (ROC) curves will be plotted to test the hypothesis that the scores are good predictors of negative HASTs. Diagnostic values of the scores will be expressed by sensitivity, specificity, positive and negative predictive values.
- Conditions
- Chronic Respiratory Disease, Hypoxia, Altitude, COPD, ILD, Cystic Fibrosis
- Being tested
- Venepuncture, Spirometry, Hypoxic altitude simulation test (HAST)
- Keywords
- gas exchange, in-flight hypoxia, hypoxic altitude simulation test, blood gas response
- Medical subject headings
- Altitude Sickness, Pulmonary Disease, Chronic Obstructive, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenepunctureDiagnostic test
A blood sample will be taken for serum bicarbonate
SpirometryDiagnostic test
All patients who have not had a spirometry in the 12 months prior to the HAST will undergo one on the day of the HAST.
Hypoxic altitude simulation test (HAST)Diagnostic test
HAST will be performed as per clinical team request. No changes to this intervention will be made for research purposes.
| Study group | Role | What they receive |
|---|---|---|
| Patients with lung disease having HAST | Patients with chronic respiratory diseases who had a hypoxic altitude simulation test (HAST) for clinical purposes will have for research purposes:
* venepuncture
* spirometry. Receives: Diagnostic Test: Venepuncture; Diagnostic Test: Spirometry; Diagnostic Test: Hypoxic altitude simulation test (HAST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROC AUC for Model 1 (3*SaO2 - HCO3 - 4 if ILD - 4 if F -3 if COPD), and the relative sensitivity, specificity, positive and negative predictive value of the threshold identified for negative and positive HAST
The score based on Model 1 will be computed for all subjects and ROC curve analyses will be used to assess predictive value. Sensitivity, specificity, PPV and NPV for criteria previously identified in a historic cohort will be assessed.
Measured: Up to 36 months
Secondary outcomes (2)
ROC AUC for the simplified score (3*SpO2 - sHCO3 - 4 if ILD - 4 if F - 3 if COPD)
The simplified score will be computed for all subjects. ROC analyses will be performed and criteria to identify negative and positive HAST at 95%, 97.5% and 99% will be chosen.
Measured: Up to 36 months
ROC AUC for Model 2, and Model 3 and for baseline pO2 and relative sensitivity, specificity, positive and negative predictive value of the previously identified thresholds.
The scores based on Model 2 and 3 will be computed for all subjects and ROC curve analyses will be used to assess predictive value. Sensitivity, specificity, PPV and NPV for criteria previously identified in a historic cohort will be assessed.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start29 Oct 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic Respiratory DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giulia Spoletini, Principal investigator, Leeds Teaching Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728595
- Sponsor's protocol ID
- RM18/109075
- Other IDs
- 247902, 18/WS/0117
- Status last verified
- Apr 2022
- First submitted
- 31 Oct 2018
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aerospace Medical Association; Aviation Safety Committee; Civil Aviation Subcommittee. Cabin cruising altitudes for regular transport aircraft. Aviat Space Environ Med. 2008 Apr;79(4):433-9. doi: 10.3357/asem.2272.2008.
PubMed 18457303Ahmedzai 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 21856702Lien D, Turner M. Recommendations for patients with chronic respiratory disease considering air travel: a statement from the Canadian Thoracic Society. Can Respir J. 1998 Mar-Apr;5(2):95-100. doi: 10.1155/1998/576501.
PubMed 9707451Aerospace Medical Association Medical Guidelines Task Force. Medical Guidelines for Airline Travel, 2nd ed. Aviat Space Environ Med. 2003 May;74(5 Suppl):A1-19. No abstract available.
PubMed 12817610Bradi AC, Faughnan ME, Stanbrook MB, Deschenes-Leek E, Chapman KR. Predicting the need for supplemental oxygen during airline flight in patients with chronic pulmonary disease: a comparison of predictive equations and altitude simulation. Can Respir J. 2009 Jul-Aug;16(4):119-24. doi: 10.1155/2009/371901.
PubMed 19707606Peckham D, Watson A, Pollard K, Etherington C, Conway SP. Predictors of desaturation during formal hypoxic challenge in adult patients with cystic fibrosis. J Cyst Fibros. 2002 Dec;1(4):281-6. doi: 10.1016/s1569-1993(02)00100-5.
PubMed 15463828Edvardsen A, Akero A, Christensen CC, Ryg M, Skjonsberg OH. Air travel and chronic obstructive pulmonary disease: a new algorithm for pre-flight evaluation. Thorax. 2012 Nov;67(11):964-9. doi: 10.1136/thoraxjnl-2012-201855. Epub 2012 Jul 5.
PubMed 22767877Edvardsen E, Akero A, Skjonsberg OH, Skrede B. Pre-flight evaluation of adult patients with cystic fibrosis: a cross-sectional study. BMC Res Notes. 2017 Feb 6;10(1):84. doi: 10.1186/s13104-017-2386-2.
PubMed 28166839
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Predictive Score to Reduce the Use of Hypoxic-altitude Simulation Test (HAST) in Patients With Chronic Respiratory Disease Planning Air Travel - an External Validation Prospective Study
- ClinicalTrials.gov ID
- NCT03728595
- Acronym / sponsor ID
- RM18/109075
- Conditions
- Chronic Respiratory Disease, Hypoxia, Altitude, COPD, ILD, Cystic Fibrosis
- Keywords
- gas exchange, in-flight hypoxia, hypoxic altitude simulation test, blood gas response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 2 Nov 2018 (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.
Patients with chronic lung diseases travelling by plane often suffer with symptoms related to lower oxygen levels they are exposed to while flying.
Therefore, patients with respiratory conditions are routinely assessed to establish if they need supplemental oxygen in flight. A hypoxic altitude simulation test (HAST) is often part of this assessment and consists in having patients breathe a oxygen/nitrogen blend with a lower oxygen concentration compared to normal room air, simulating in-flight conditions. Oxygen levels are measured before and after the test through a blood sample (from the earlobe or an artery in the wrist) and with a finger probe. In-flight oxygen is required if the oxygen level in the blood is lower than 6.6 kPa. HASTs are time consuming, costly, and require a dedicated hospital appointment.
Using historical data, the Investigators developed scores based on capillary blood gas (blood sample from the earlobe), diagnosis and sex to predict the outcome of the HASTs. The Investigators validated the proposed scores in a separate historic cohort of patients and showed it had good concordance with the HASTs results.
In this study, the Investigators want to confirm prospectively if the score, based on blood results (venous and/or earlobe), can predict the outcome of the HASTs and therefore reduce the number of tests performed, travel time for patients, and costs for the NHS.
All patients, aged 18 or older, who are having a HAST for clinical purposes at the cardio-respiratory lab at Leeds Teaching Hospital NHS Trust will be invited to take part in the study. The Investigators will record diagnosis, results of HAST and previous spirometry from the medical notes, perform a spirometry if not done in the previous 12 months and collect a blood sample (one tube, 4 mls). With these data, the Investigators will calculate the score and assess its agreement with the outcome of the HAST.
Each participant's involvement in the study will last for approximately 90-120 minutes, which is the normal duration of a HAST.
The Investigators aim to include up to 280 subjects in the study.
Detailed description
Over the last two decades, there has been a significant increase in the number of people flying on a regular basis. As a result, more individuals with chronic respiratory disease are being referred for formal assessment to assess if they require inflight oxygen.
At cruising altitude, passengers are exposed to reduced atmospheric pressure equivalent to an altitude of 8000 ft, corresponding to a reduction of oxygen from 21% to approximately 15%. National and International recommendations on air travel suggest screening patients with chronic lung diseases for the need of in-flight oxygen supplementation. However, due to the paucity of available evidence, there is no consensus on which investigation should be performed and the precise risk factors associated with in-flight complications.
The British Thoracic Society, which published the most recent and comprehensive recommendations on this topic, recommends that patients with respiratory diseases should be assessed clinically, and in specific situations, a hypoxic altitude simulation tests (HAST) should be performed. Unfortunately, the vast majority of these recommendations are level C at best, as current evidence is limited to a handful of prospective or retrospective analyses.
A standard hypoxic altitude simulation test requires the patients to breathe a blend of 15% oxygen in nitrogen for 20 minutes. This simulates the oxygen tension at 8000 ft, the equivalent cabin pressure. Blood gas measurements are taken before and after the test. A fall in the pO2 below 6.6 kPa is considered indicative for use of in-flight oxygen.
Often the HASTs yield negative results (i.e. no inflight oxygen required). These tests are heavy on resources, time consuming, costly, not widely available and require dedicate hospital appointment. Thus, predictors of outcomes of HASTs are needed to reduce the number of HASTs performed.
Several studies have looked at predictors of oxygen desaturation during HAST in varying populations with the aim of better selecting patients who need the test. However, results have been inconclusive. Data on the role of baseline oxygenation, FEV1 and exercise test in predicting oxygen desaturation during the HAST are conflicting and most studies have been too small to provide decisive answers.
The Investigators recently developed and validate, on historical data, three scores to predict negative HASTs, according to the BTS 2011 recommendations (i.e. scores predicting which patients do not need to undergo a formal assessment). All of these had good ROC AUC and agreement with the outcome of the HAST in the retrospective dataset.
The Investigators hypothesise that the multivariable score (Model 1), based on a combination of CBG variables (bicarbonate and oxygen saturation) and baseline diagnosis (ILD and COPD) would be the best predictor of negative response in a formal HAST. Furthermore, the Investigator hypothesise that the score could be further simplified for the use in clinical practice by measuring the serum bicarbonate and oxygen saturation through a pulse oximeter (Model 1s). This is in light of the good arterio-venous concordance previously demonstrated for bicarbonate and of the good reliability of non-invasive measurement of oxygen saturation. Such a simplified score, if its predictive value is confirmed, would not only reduce the number of unnecessary HAST performed, but also minimise patients' discomfort and hospital appointments, reducing the costs for the NHS.
In this prospective single centre study, the Investigators will assess the validity of the best performing score (Model 1) derived in our retrospective study for negative HAST. In addition, the Investigators want to verify whether the use of SpO2 in place of SO2 and of serum bicarbonate in place of capHCO3 would allow for similar results. The investigators also aim to evaluate the performance of the other predictive scores previously derived in our retrospective analysis, and, if none of these models are a good and effective predictor, we aim to develop a new model based on newly measured data.
The Investigators aim to enroll up to 280 subjects, but interim analyses will be performed with the scope to early terminate the study if primary outcome is met.
Demographic and baseline characteristics of patients will be analysed on the whole population and by the cohorts depending on the underlying diagnosis and the outcome of the HAST.
Receiver operating characteristics (ROC) curves will be plotted to test the hypothesis that the scores are good predictors of negative HASTs. Diagnostic values of the scores will be expressed by sensitivity, specificity, positive and negative predictive values.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with lung disease having HAST | – | Diagnostic Test: Venepuncture, Diagnostic Test: Spirometry, Diagnostic Test: Hypoxic altitude simulation test (HAST)Patients with chronic respiratory diseases who had a hypoxic altitude simulation test (HAST) for clinical purposes will have for research purposes: * venepuncture * spirometry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient attending for a HAST at Leeds Teaching Hospital NHS Trust.
Key inclusion criteria (3 listed)
- Age ≥18 years old (at the time of HAST)
- Clinically stable
- Hypoxic altitude simulation test, scheduled as part of the clinical care
Key exclusion criteria (2 listed)
- Inability to provide informed consent
- Being part of a clinical trial, which would exclude patients who are taking part in other studies including observational studies.
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 |
|---|---|---|
| VenepunctureA blood sample will be taken for serum bicarbonate | Diagnostic test | Patients with lung disease having HAST |
| SpirometryAll patients who have not had a spirometry in the 12 months prior to the HAST will undergo one on the day of the HAST. | Diagnostic test | Patients with lung disease having HAST |
| Hypoxic altitude simulation test (HAST)HAST will be performed as per clinical team request. No changes to this intervention will be made for research purposes. | Diagnostic test | Patients with lung disease having HAST |
Primary outcome
ROC AUC for Model 1 (3*SaO2 - HCO3 - 4 if ILD - 4 if F -3 if COPD), and the relative sensitivity, specificity, positive and negative predictive value of the threshold identified for negative and positive HAST
Time frame: Up to 36 months
The score based on Model 1 will be computed for all subjects and ROC curve analyses will be used to assess predictive value. Sensitivity, specificity, PPV and NPV for criteria previously identified in a historic cohort will be assessed.
2 secondary outcomes
ROC AUC for the simplified score (3*SpO2 - sHCO3 - 4 if ILD - 4 if F - 3 if COPD)
Time frame: Up to 36 months
ROC AUC for Model 2, and Model 3 and for baseline pO2 and relative sensitivity, specificity, positive and negative predictive value of the previously identified thresholds.
Time frame: Up to 36 months
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 Apr 2022.
- Background: PubMed 18457303Aerospace Medical Association; Aviation Safety Committee; Civil Aviation Subcommittee. Cabin cruising altitudes for regular transport aircraft. Aviat Space Environ Med. 2008 Apr;79(4):433-9. doi: 10.3357/asem.2272.2008.
- Background: 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.
- Background: PubMed 9707451Lien D, Turner M. Recommendations for patients with chronic respiratory disease considering air travel: a statement from the Canadian Thoracic Society. Can Respir J. 1998 Mar-Apr;5(2):95-100. doi: 10.1155/1998/576501.
- Background: PubMed 12817610Aerospace Medical Association Medical Guidelines Task Force. Medical Guidelines for Airline Travel, 2nd ed. Aviat Space Environ Med. 2003 May;74(5 Suppl):A1-19. No abstract available.
- Background: PubMed 19707606Bradi AC, Faughnan ME, Stanbrook MB, Deschenes-Leek E, Chapman KR. Predicting the need for supplemental oxygen during airline flight in patients with chronic pulmonary disease: a comparison of predictive equations and altitude simulation. Can Respir J. 2009 Jul-Aug;16(4):119-24. doi: 10.1155/2009/371901.
- Background: PubMed 15463828Peckham D, Watson A, Pollard K, Etherington C, Conway SP. Predictors of desaturation during formal hypoxic challenge in adult patients with cystic fibrosis. J Cyst Fibros. 2002 Dec;1(4):281-6. doi: 10.1016/s1569-1993(02)00100-5.
- Background: PubMed 22767877Edvardsen A, Akero A, Christensen CC, Ryg M, Skjonsberg OH. Air travel and chronic obstructive pulmonary disease: a new algorithm for pre-flight evaluation. Thorax. 2012 Nov;67(11):964-9. doi: 10.1136/thoraxjnl-2012-201855. Epub 2012 Jul 5.
- Background: PubMed 28166839Edvardsen E, Akero A, Skjonsberg OH, Skrede B. Pre-flight evaluation of adult patients with cystic fibrosis: a cross-sectional study. BMC Res Notes. 2017 Feb 6;10(1):84. doi: 10.1186/s13104-017-2386-2.
- Individual participant dataSharing planned: No
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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.
Giulia Spoletini principal investigator
Leeds Teaching Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Respiratory Disease and Hypoxia, Altitude, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 3 inclusion and 2 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 Apr 2022. 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 United Kingdom. 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?
ROC AUC for Model 1 (3*SaO2 - HCO3 - 4 if ILD - 4 if F -3 if COPD), and the relative sensitivity, specificity, positive and negative predictive value of the threshold identified for negative and positive HAST (time frame: Up to 36 months). 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 NCT03728595, which also lists 8 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 Apr 2022.