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Not yet recruiting NCT07639931

Key Diagnostic & Therapeutic Technologies for Severe Acute High Altitude Disease (SAHAD): Integration and Application

No phase Interventional Severe High Altitude Pulmonary Edema Severe High Altitude Cerebral Edema

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multicenter study of HAPE：CPAP or BiPAP Group, Multicenter study of HAPE group：NO Group, Protocol for Proteomics and Peptidomics Study of HAPE：Case Group.
Who it may be relevant to
Registry conditions: Severe High Altitude Pulmonary Edema, Severe High Altitude Cerebral Edema. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Integration and Application Demonstration of Key Diagnosis and Treatment Technologies for Severe Acute High Altitude Disease

Overview

This study aims to establish a key technical system for the diagnosis and treatment of severe acute mountain sickness based on real-world clinical data in Xizang, develop standardized diagnosis and treatment protocols and an intelligent early warning model, validate its efficacy through multicenter studies, and innovate diagnostic and therapeutic technologies. It will achieve early identification, precise diagnosis, standardized treatment, and intelligent warning of severe acute mountain sickness, comprehensively improving its prevention, control and treatment success rate.

Interventions

  • Device Multicenter study of HAPE：CPAP or BiPAP Group
    Traditional treatment plus CPAP or BiPAP
  • Drug Multicenter study of HAPE group：NO Group
    Traditional treatment plus inhaled nitric oxide therapy (20-40 ppm, continuous administration for 12-24 hours)
  • Other Protocol for Proteomics and Peptidomics Study of HAPE：Case Group
    40 patients clinically diagnosed with HAPE. Peripheral venous blood samples were collected during the acute onset stage and prior to any effective intervention.

Primary outcome measures

  • HAPE：Recovery [Time frame: From date of disease onset to achievement of recovery criteria ,assessed up to 36 months]
  • HACE ：recovery [Time frame: From date of disease onset to achievement of recovery criteria ,assessed up to 36 months]
  • Death [Time frame: From admission to discharge, or all-cause mortality within 30 days and 90 days after discharge.]
  • Length of hospital stay [Time frame: The total duration from the first day of hospitalization to recovery and discharge, assessed up to 36 months]
Secondary outcome measures (9)
  • HAPE：Improvement [Time frame: At discharge(assessed up to 5 days)]
  • Length of ICU/CCU stay [Time frame: From date of the first day admimion in the ICU until the last day in the ICU, up to 48 weeks.]
  • Duration of mechanical ventilation [Time frame: From the date of the first day of mechanical ventilation until the last day of mechanical ventilation,up to 48 weeks.]
  • Total hospitalization cost (CNY) [Time frame: At discharge(assessed up to 5 days)]
  • Time to independence from oxygen therapy (days) [Time frame: At discharge(assessed up to 5 days)]
  • HAPE：incidence of complications [Time frame: From date of admission until the date of discharge, and within 30 days and 90 days after discharge,up to 48 weeks.]
  • HACE：improved [Time frame: At discharge(assessed up to 5 days)]
  • HACE：Incidence of complications [Time frame: From date of admission until the date of discharge, and within 30 days and 90 days after discharge,up to 48 weeks.]
  • HACE：Modified Rankin Scale (mRS) score at 90 days [Time frame: From the first day of admission to 90 days thereafter]

Eligibility criteria

Inclusion criteria

  • Meeting the diagnostic criteria for severe acute mountain sickness (including high-altitude pulmonary edema \[HAPE\] and high-altitude cerebral edema \[HACE\]).
  • Aged 18 to 75 years.
  • Rapid ascent to an altitude above 2500 m within 72 hours prior to onset.

Exclusion criteria

  • History of severe cardiopulmonary diseases.
  • Pregnant women, patients with psychiatric disorders, inability to cooperate with treatment or follow-up, and patients with an expected survival of less than 6 months.
  • Patients with malignant tumors, severe hepatic or renal insufficiency, or immune system diseases requiring immunosuppressive therapy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Xizang Autonomous Region People's Hospital — Lhasa

Identifiers

NCT: NCT07639931 · ME-TBHP-25-090

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗