High Altitude Pulmonary EdemaNCT04288219
Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema
A study testing Non-Invasive Positive Pressure Ventilation, Nifedipine and supplemental oxygen in people with High Altitude Pulmonary Edema and Non-Invasive Positive Pressure Ventilation, run by Massachusetts General Hospital at 1 site in Nepal.
Trial summary
Trial of Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- High Altitude Pulmonary Edema, Non-Invasive Positive Pressure Ventilation, Hypoxia
- What is being tested?
- Non-Invasive Positive Pressure Ventilation, Nifedipine and supplemental oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNepal
- Study dates
- 1 Mar 2020to Jun 2021
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults (age 18-80)
- Travel through Pheriche, Nepal
- Diagnosis of HAPE by symptoms, vital signs, and lung ultrasound
Who cannot join
- History of chronic respiratory conditions (asthma, COPD, ILD)
- Concomitant pneumonia or aspiration, cardiomyopathy, congestive heart failure
- Kidney disease
- Neurologic disorder
- Cognitive disorder
- Temporary altered mental status
Show all 9Show fewer
- Use of phosphodiesterase inhibitors or nifedipine prior to diagnosis of HAPE
- Age under 18 or over 80
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Nepal1 site, 1 recruiting
- Recruiting
Himalayan Rescue Association
Kathmandu
Brian Strickland, MD, +977 1-4440293, bstrickland@mgh.harvard.edu
Brian M Strickland, MD
About this study
Trial of Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema
Read the detailed description
Patients in the Everest area will assessed for evidence of acute HAPE. Subjects will be randomized and assigned to standard care options or treatment with Non-Invasive Positive Pressure Ventilation.
- Being tested
- Non-Invasive Positive Pressure Ventilation, Nifedipine, supplemental oxygen
- Medical subject headings
- Altitude Sickness, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive Positive Pressure VentilationDevice
Also called CPAP
Continuous positive airway pressure delivered by face mask at 10cmH2O
NifedipineDrug
Nifedipine 30mg, Pharmacotherapy
supplemental oxygenOther
supplemental oxygen
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Treatment | Active comparator | Continuous supplemental oxygen and nifedipine 30mg will be administered to patients. Receives: Drug: Nifedipine; Other: supplemental oxygen |
| Non-Invasive Positive Pressure Ventilation Management | Experimental | CPAP at 10mmHg with supplemental oxygen, as well as nifedipine 30mg will be administered to patients. Receives: Device: Non-Invasive Positive Pressure Ventilation; Drug: Nifedipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation
Displayed on pulse oximeter
Measured: Up to 4 hours
Secondary outcomes (2)
Ultrasonographic assessment of pulmonary edema
Quantification of B-lines
Measured: Up to 4 hours
Subjective rating of dyspnea
Based on Dypnea Severity Scale (DSS)
Measured: Up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start1 Mar 2020
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Altitude Pulmonary EdemaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Himalayan Rescue Association
- Responsible party
- Principal investigator, N. Stuart Harris MD MFA, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288219
- Sponsor's protocol ID
- 2019P003234
- Status last verified
- Sep 2020
- First submitted
- 25 Feb 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema
- ClinicalTrials.gov ID
- NCT04288219
- Acronym / sponsor ID
- 2019P003234
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Himalayan Rescue Association
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 28 Feb 2020 (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.
Trial of Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema
Detailed description
Patients in the Everest area will assessed for evidence of acute HAPE. Subjects will be randomized and assigned to standard care options or treatment with Non-Invasive Positive Pressure Ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Treatment | Active comparator | Drug: Nifedipine, Other: supplemental oxygenContinuous supplemental oxygen and nifedipine 30mg will be administered to patients. |
| Non-Invasive Positive Pressure Ventilation Management | Experimental | Device: Non-Invasive Positive Pressure Ventilation, Drug: NifedipineCPAP at 10mmHg with supplemental oxygen, as well as nifedipine 30mg will be administered to patients. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adults (age 18-80)
- Travel through Pheriche, Nepal
- Diagnosis of HAPE by symptoms, vital signs, and lung ultrasound
Key exclusion criteria (9 listed)
- History of chronic respiratory conditions (asthma, COPD, ILD)
- Concomitant pneumonia or aspiration, cardiomyopathy, congestive heart failure
- Kidney disease
- Neurologic disorder
- Cognitive disorder
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 |
|---|---|---|
| Non-Invasive Positive Pressure VentilationAlso: CPAPContinuous positive airway pressure delivered by face mask at 10cmH2O | Device | Non-Invasive Positive Pressure Ventilation Management |
| NifedipineNifedipine 30mg, Pharmacotherapy | Drug | Non-Invasive Positive Pressure Ventilation Management, Standard of Care Treatment |
| supplemental oxygensupplemental oxygen | Other | Standard of Care Treatment |
Primary outcome
Oxygen saturation
Time frame: Up to 4 hours
Displayed on pulse oximeter
2 secondary outcomes
Ultrasonographic assessment of pulmonary edema
Time frame: Up to 4 hours
Subjective rating of dyspnea
Time frame: Up to 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Individual participant dataSharing planned: No
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Assessment of Total Pulmonary Resistance sPAP/CO Between High Altitude HA vs. Sea Level LA in Healthy Individuals H
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Invasive Positive Pressure Ventilation, Nifedipine and supplemental oxygen in people with High Altitude Pulmonary Edema and Non-Invasive Positive Pressure Ventilation, run by Massachusetts General Hospital at 1 site in Nepal.
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 9 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: status not confirmed, as of the sponsor's last update on 3 Sep 2020. 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 Nepal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact N. Stuart Harris, MD, MFA (617-724-3290, nsharris@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen saturation (time frame: Up to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2020.