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

Primary Purpose

High Altitude Pulmonary Edema

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Continuous positive airway pressure machine
Sponsored by
sultan mehmood kamran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High Altitude Pulmonary Edema focused on measuring high altitude, CPAP, hyperbaric chamber, Gamow bag, AMS

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    CPAP arm

    Gamow bag arm/hyperbaric chamber

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    January 10, 2021
    Last Updated
    January 12, 2021
    Sponsor
    sultan mehmood kamran
    Collaborators
    Pak Emirates Military Hospital Rawalpindi, Pakistan, HALMARC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04710953
    Brief Title
    Comparison of CPAP and Gamow Bag Ventilation to Treat HAPE
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2021 (Anticipated)
    Primary Completion Date
    April 2022 (Anticipated)
    Study Completion Date
    April 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    sultan mehmood kamran
    Collaborators
    Pak Emirates Military Hospital Rawalpindi, Pakistan, HALMARC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    High Altitude Pulmonary Edema
    Keywords
    high altitude, CPAP, hyperbaric chamber, Gamow bag, AMS

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CPAP arm
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Gamow bag arm/hyperbaric chamber
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Continuous positive airway pressure machine
    Other Intervention Name(s)
    CPAP-REMstar pro (system one 60 series)
    Intervention Description
    CPAP device set at 6-8cmH2O for several hours
    Primary Outcome Measure Information:
    Title
    Resolution of HAPE
    Description
    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
    Time Frame
    8 hours
    Secondary Outcome Measure Information:
    Title
    Partial improvement in HAPE features
    Description
    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
    Time Frame
    8 hours

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Farrukh Saeed, FCPS
    Phone
    03339266404
    Email
    Farrukhsaeed545@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Imran Fazal, FCPS
    Organizational Affiliation
    Pak Emirates Military Hospital Rawalpindi
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    12527602
    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.
    Results Reference
    result
    PubMed Identifier
    24067184
    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.
    Results Reference
    result
    PubMed Identifier
    19124989
    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.
    Results Reference
    result
    PubMed Identifier
    23795742
    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.
    Results Reference
    result

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    Comparison of CPAP and Gamow Bag Ventilation to Treat HAPE

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