High Altitude Pulmonary EdemaCPAPNCT04710953
Comparison of CPAP and Gamow Bag Ventilation to Treat HAPE
A study testing Continuous positive airway pressure machine in people with High Altitude Pulmonary Edema, run by sultan mehmood kamran.
Trial summary
High altitude pulmonary edema (HAPE) is mostly treated with supplemental oxygen, nifedipine 30mg twice a day, rest, limiting cold exposure and descent (simulated or actual) Gamow Bag provides simulated descent and buy time for actual descent. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- High Altitude Pulmonary Edema
- What is being tested?
- Continuous positive airway pressure machine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to Apr 2022
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male gender
- Age 18-45 years
- Previously fit and no comorbids
- Suspected HAPE
- --arrived in the past 01 week on the post
- Expected evacuation from post more than 8 hours
Who cannot join
- Symptoms suggest acute infective etiology.
- Symptoms after one week of stay at HA
- Altered mental status.
- Disturbed balance
- Visual impairment
- Severe headache
- A speedy evacuation to a lower height is available
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Effectiveness Between Continuous Positive Airway Pressure (CPAP) and Hyperbaric Chamber Ventilation for the Patients of High Altitude Pulmonary Edema (HAPE) When Given in Addition to Standard of care-a Randomized Control Trial
High altitude pulmonary edema (HAPE) is mostly treated with supplemental oxygen, nifedipine 30mg twice a day, rest, limiting cold exposure and descent (simulated or actual) Gamow Bag provides simulated descent and buy time for actual descent. CPAP is claimed to be effective in many case reports to treat HAPE temporarily until actual descent is taken place. This study aims to evaluate the role of CPAP in treating HAPE at those high altitude stations where Gamow bag is not available and immediate descent is not possible.
Read the detailed description
Background:
Swenson described HAPE in 2002, as a form of hydrostatic acute pulmonary edema with an alteration of alveolar-capillary permeability. Overall prevalence of AMS is 10-20% while incidence of HAPE, HACE or mixed incidence is 2-3%. Highest reported incidence of HAPE among Indian soldiers climbing to Siachen glacier is 15.5%. At 1500-2400m, A series of 52 patients admitted for HAPE over a period of 9 years was reported in literature..
Scientific rationale:
Positive pressure has been used to increase altitude tolerance since the 1940s under simulated altitudes. PEEP applied via face mask increased SpO2 and decreased AMS symptoms. CPAP was used after ascent to 3205 m on Mount Cook in New Zealand where it improved SpO2 and reduced symptoms of HAPE. A CPAP helmet providing 15 cmH20 CPAP improved SpO2 in a single HAPE patient (at 5300 m) from 56% to 74%.-1st case report. A study at Thorang La pass (5416 m) in October 2010 in the Nepal Himalaya found that nasal continuous positive airway pressure (CPAP) is useful as an additional modality to treat presumed high altitude pulmonary edema (HAPE)- 2nd case report.
- Conditions
- High Altitude Pulmonary Edema
- Being tested
- Continuous positive airway pressure machine
- Keywords
- high altitude, CPAP, hyperbaric chamber, Gamow bag, AMS
- 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 positive airway pressure machineDevice
Also called CPAP-REMstar pro (system one 60 series)
CPAP device set at 6-8cmH2O for several hours
| Study group | Role | What they receive |
|---|---|---|
| CPAP arm | Experimental | In addition to standard of care, CPAP will be provided at high altitude posts where Gamow bag is not available and all patients of HAPE will be given CPAP when evacuation/descent is either not possible or delayed due to weather conditions. Receives: Device: Continuous positive airway pressure machine |
| Gamow bag arm/hyperbaric chamber | No intervention | Posts where Gamow bag would be available, the patients of HAPE will be given standard of care and will be asked to lie inside Gamow bag inflated at 2 Psi for several hours to simulate a descent of 1500 meters when evacuation/descent is either not possible or delayed due to weather conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of HAPE
No dyspnea at rest, 2. RR < 20 3. Pulse < 100 4. O2 sat > 90% 5. Chest clears to auscultation
Pulse < 100 O2 sat > 90% CheComplete resolution of HAPE symptoms RR < 20 Pulse < 100 O2 sat > 90% Chest clear to auscultation complete resolution of HAPE symptoms with RR < 20, Pulse < 100, O2 saturation > 92% and chest clear to auscultation
Measured: 8 hours
Secondary outcomes (1)
Partial improvement in HAPE features
Partial improvement in symptoms and signs as measured by at least one grade improvement in MMRC score, at least 25 percent improvement in all or some of the vital signs or oxygen saturations
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study startApr 2021 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for High Altitude Pulmonary EdemaStudies 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
- Parallel groups
- Model description
- Study Design: Randomised control trial Settings: Posts more than 8000 feet (2400m) where Medical officer is available Study Duration: 01 year after the study is approved Sampling Technique: Non probability consecutive sampling Distribution of patients in to two groups (Gp A and Gp B) by consecutive sampling Group "A" will be given CPAP in addition to standard of care and Group B will be offered Gamow bag in addition to standard of care
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- sultan mehmood kamran
- Sponsor type
- University, hospital or other
- Collaborators
- Pak Emirates Military Hospital, HALMARC
- Responsible party
- Sponsor-investigator, sultan mehmood kamran, UNICEF
- Investigators
- Imran Fazal, FCPS, Study director, Pak Emirates Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710953
- Sponsor's protocol ID
- HALMARC
- Acronym
- CPAP
- Status last verified
- Jan 2021
- First submitted
- 10 Jan 2021
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gabry AL, Ledoux X, Mozziconacci M, Martin C. High-altitude pulmonary edema at moderate altitude (< 2,400 m; 7,870 feet): a series of 52 patients. Chest. 2003 Jan;123(1):49-53. doi: 10.1378/chest.123.1.49.
PubMed 12527602Johnson PL, Johnson CC, Poudyal P, Regmi N, Walmsley MA, Basnyat B. Continuous positive airway pressure treatment for acute mountain sickness at 4240 m in the Nepal Himalaya. High Alt Med Biol. 2013 Sep;14(3):230-3. doi: 10.1089/ham.2013.1015.
PubMed 24067184Koch RO, Hinterhuber L, Faulhaber M, Gatterer H, Graupner S, Muenzel K, Burtscher M. A successful therapy of high-altitude pulmonary edema with a CPAP helmet on Lenin Peak. Clin J Sport Med. 2009 Jan;19(1):72-3. doi: 10.1097/JSM.0b013e3181915cce. No abstract available.
PubMed 19124989Ginosar Y, Malhotra A, Schwartz E. High altitude, continuous positive airway pressure, and obstructive sleep apnea: subjective observations and objective data. High Alt Med Biol. 2013 Jun;14(2):186-9. doi: 10.1089/ham.2012.1085.
PubMed 23795742
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness Between Continuous Positive Airway Pressure (CPAP) and Hyperbaric Chamber Ventilation for the Patients of High Altitude Pulmonary Edema (HAPE) When Given in Addition to Standard of care-a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04710953
- Acronym / sponsor ID
- CPAP / HALMARC
- Conditions
- High Altitude Pulmonary Edema
- Keywords
- high altitude, CPAP, hyperbaric chamber, Gamow bag, AMS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- sultan mehmood kamranUniversity, hospital or other
- Collaborators
- Pak Emirates Military Hospital, HALMARC
- Study start
- Apr 2021 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 15 Jan 2021 (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.
High altitude pulmonary edema (HAPE) is mostly treated with supplemental oxygen, nifedipine 30mg twice a day, rest, limiting cold exposure and descent (simulated or actual) Gamow Bag provides simulated descent and buy time for actual descent. CPAP is claimed to be effective in many case reports to treat HAPE temporarily until actual descent is taken place. This study aims to evaluate the role of CPAP in treating HAPE at those high altitude stations where Gamow bag is not available and immediate descent is not possible.
Detailed description
Background:
Swenson described HAPE in 2002, as a form of hydrostatic acute pulmonary edema with an alteration of alveolar-capillary permeability. Overall prevalence of AMS is 10-20% while incidence of HAPE, HACE or mixed incidence is 2-3%. Highest reported incidence of HAPE among Indian soldiers climbing to Siachen glacier is 15.5%. At 1500-2400m, A series of 52 patients admitted for HAPE over a period of 9 years was reported in literature..
Scientific rationale:
Positive pressure has been used to increase altitude tolerance since the 1940s under simulated altitudes. PEEP applied via face mask increased SpO2 and decreased AMS symptoms. CPAP was used after ascent to 3205 m on Mount Cook in New Zealand where it improved SpO2 and reduced symptoms of HAPE. A CPAP helmet providing 15 cmH20 CPAP improved SpO2 in a single HAPE patient (at 5300 m) from 56% to 74%.-1st case report. A study at Thorang La pass (5416 m) in October 2010 in the Nepal Himalaya found that nasal continuous positive airway pressure (CPAP) is useful as an additional modality to treat presumed high altitude pulmonary edema (HAPE)- 2nd case report.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study Design: Randomised control trial Settings: Posts more than 8000 feet (2400m) where Medical officer is available Study Duration: 01 year after the study is approved Sampling Technique: Non probability consecutive sampling Distribution of patients in to two groups (Gp A and Gp B) by consecutive sampling Group "A" will be given CPAP in addition to standard of care and Group B will be offered Gamow bag in addition to standard of care
| Arm | Type | Receives |
|---|---|---|
| CPAP arm | Experimental | Device: Continuous positive airway pressure machineIn addition to standard of care, CPAP will be provided at high altitude posts where Gamow bag is not available and all patients of HAPE will be given CPAP when evacuation/descent is either not possible or delayed due to weather conditions. |
| Gamow bag arm/hyperbaric chamber | No intervention | –Posts where Gamow bag would be available, the patients of HAPE will be given standard of care and will be asked to lie inside Gamow bag inflated at 2 Psi for several hours to simulate a descent of 1500 meters when evacuation/descent is either not possible or delayed due to weather conditions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male gender
- Age 18-45 years
- Previously fit and no comorbids
- Suspected HAPE
- --arrived in the past 01 week on the post
Key exclusion criteria (7 listed)
- Symptoms suggest acute infective etiology.
- Symptoms after one week of stay at HA
- Altered mental status.
- Disturbed balance
- Visual impairment
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 positive airway pressure machineAlso: CPAP-REMstar pro (system one 60 series)CPAP device set at 6-8cmH2O for several hours | Device | CPAP arm |
Primary outcome
Resolution of HAPE
Time frame: 8 hours
No dyspnea at rest, 2. RR < 20 3. Pulse < 100 4. O2 sat > 90% 5. Chest clears to auscultation Pulse < 100 O2 sat > 90% CheComplete resolution of HAPE symptoms RR < 20 Pulse < 100 O2 sat > 90% Chest clear to auscultation complete resolution of HAPE symptoms with RR < 20, Pulse < 100, O2 saturation > 92% and chest clear to auscultation
1 secondary outcome
Partial improvement in HAPE features
Time frame: 8 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Results publication: PubMed 12527602Gabry AL, Ledoux X, Mozziconacci M, Martin C. High-altitude pulmonary edema at moderate altitude (< 2,400 m; 7,870 feet): a series of 52 patients. Chest. 2003 Jan;123(1):49-53. doi: 10.1378/chest.123.1.49.
- Results publication: PubMed 24067184Johnson PL, Johnson CC, Poudyal P, Regmi N, Walmsley MA, Basnyat B. Continuous positive airway pressure treatment for acute mountain sickness at 4240 m in the Nepal Himalaya. High Alt Med Biol. 2013 Sep;14(3):230-3. doi: 10.1089/ham.2013.1015.
- Results publication: PubMed 19124989Koch RO, Hinterhuber L, Faulhaber M, Gatterer H, Graupner S, Muenzel K, Burtscher M. A successful therapy of high-altitude pulmonary edema with a CPAP helmet on Lenin Peak. Clin J Sport Med. 2009 Jan;19(1):72-3. doi: 10.1097/JSM.0b013e3181915cce. No abstract available.
- Results publication: PubMed 23795742Ginosar Y, Malhotra A, Schwartz E. High altitude, continuous positive airway pressure, and obstructive sleep apnea: subjective observations and objective data. High Alt Med Biol. 2013 Jun;14(2):186-9. doi: 10.1089/ham.2012.1085.
- 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.
Imran Fazal, FCPS study director
Pak Emirates Military Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Continuous positive airway pressure machine in people with High Altitude Pulmonary Edema, run by sultan mehmood kamran.
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 6 inclusion and 7 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 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Farrukh Saeed, FCPS (03339266404, Farrukhsaeed545@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of HAPE (time frame: 8 hours). 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 NCT04710953, which also lists 4 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 15 Jan 2021.