Comparison of CPAP and Gamow Bag Ventilation to Treat HAPE

NCT04710953 | Unknown DMC FDA Device

• 1 other identifier: HALMARC
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

High Altitude Pulmonary Edema

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  8 hours

Secondary Outcomes (1)

• Partial improvement in HAPE features

  8 hours

Study Arms (2)

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.

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.

Interventions

Continuous positive airway pressure machine DEVICE

CPAP device set at 6-8cmH2O for several hours

Also known as: CPAP-REMstar pro (system one 60 series)

CPAP arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• sultan mehmood kamran: lead
• Pak Emirates Military Hospital: collaborator
• HALMARC: collaborator

Related Publications (4)

• 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.

  PMID: 12527602 RESULT

• 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.

  PMID: 24067184 RESULT

• 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.

  PMID: 19124989 RESULT

• 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.

  PMID: 23795742 RESULT

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Imran Fazal, FCPS

  Pak Emirates Military Hospital Rawalpindi

  STUDY DIRECTOR

Central Study Contacts

Farrukh Saeed, FCPS

CONTACT

03339266404; Farrukhsaeed545@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Classified Medical specialist

Model Details: 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

Study Record Dates

• First Submitted: January 10, 2021
• First Posted: January 15, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share