Clinical trial NCT04710953: Comparison of CPAP and Gamow Bag Ventilation to Treat HAPE
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: High Altitude Pulmonary Edema
Keywords: high altitude
CPAP
hyperbaric chamber
Gamow bag
AMS
Lead sponsor: UNICEF
Sponsor class: OTHER
Collaborators: name: Pak Emirates Military Hospital
name: HALMARC
First posted: 2021-01-15
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Resolution of HAPE
timeFrame: 8 hours
Secondary outcomes:
measure: Partial improvement in HAPE features
timeFrame: 8 hours
Other outcomes:
Locations:
Study officials:
affiliation: Pak Emirates Military Hospital Rawalpindi
name: Imran Fazal, FCPS
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Johnson 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.
citation: Koch 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.
citation: Ginosar 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.