Comparison of CPAP and Gamow Bag Ventilation to Treat HAPE

High Altitude Pulmonary Edema Clinical Trial

— CPAP  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04710953
• Other study ID #: HALMARC
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2021
• Est. completion date: April 2022

Study information

• Verified date: January 2021
• Source: UNICEF
• Contact: Farrukh Saeed, FCPS
• Phone: 03339266404
• Email: Farrukhsaeed545[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Altitude Sickness
• High Altitude Pulmonary Edema
• Hypertension, Pulmonary
• Pulmonary Edema

Intervention

Device:
• Continuous positive airway pressure machine
CPAP device set at 6-8cmH2O for several hours

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
sultan mehmood kamran	HALMARC, Pak Emirates Military Hospital Rawalpindi, Pakistan

References & 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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