Comparison of CPAP and Gamow Bag Ventilation to Treat HAPE (CPAP)

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.

Study Overview

• Status: Unknown
• Conditions: High Altitude Pulmonary Edema
• Intervention / Treatment: Device: Continuous positive airway pressure machine

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CPAP arm; 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; CPAP device set at 6-8cmH2O for several hours; Other Names: CPAP-REMstar pro (system one 60 series)
NO_INTERVENTION: Gamow bag arm/hyperbaric chamber; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 hours

Collaborators and Investigators

• Sponsor: sultan mehmood kamran
• Collaborators: Pak Emirates Military Hospital Rawalpindi, Pakistan; HALMARC
• Investigators: Study Director: Imran Fazal, FCPS, Pak Emirates Military Hospital Rawalpindi

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2021
• Primary Completion (ANTICIPATED): April 1, 2022
• Study Completion (ANTICIPATED): April 1, 2022

Study Registration Dates

• First Submitted: January 10, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (ACTUAL): January 15, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: CPAP; hyperbaric chamber; high altitude; AMS; Gamow bag
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Hypertension; Altitude Sickness; Hypertension, Pulmonary; Pulmonary Edema
• Other Study ID Numbers: HALMARC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes