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Comparison of CPAP and Gamow Bag Ventilation to Treat HAPE

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04710953
Acronym
CPAP
Enrollment
30
Registered
2021-01-15
Start date
2021-04-30
Completion date
2022-04-30
Last updated
2021-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Altitude Pulmonary Edema

Keywords

high altitude, CPAP, hyperbaric chamber, Gamow bag, AMS

Brief 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. 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.

Interventions

CPAP device set at 6-8cmH2O for several hours

Sponsors

Pak Emirates Military Hospital
CollaboratorOTHER
HALMARC
CollaboratorUNKNOWN
sultan mehmood kamran
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Resolution of HAPE8 hoursNo 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

Secondary

MeasureTime frameDescription
Partial improvement in HAPE features8 hoursPartial 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

Contacts

Primary ContactFarrukh Saeed, FCPS
Farrukhsaeed545@gmail.com03339266404

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026