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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTibet Autonomous Region People's Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multicenter study of HAPE:CPAP or BiPAP Group

    Device

    Traditional treatment plus CPAP or BiPAP

  • Multicenter study of HAPE group:NO Group

    Drug

    Traditional treatment plus inhaled nitric oxide therapy (20-40 ppm, continuous administration for 12-24 hours)

  • Protocol for Proteomics and Peptidomics Study of HAPE:Case Group

    Other intervention

    40 patients clinically diagnosed with HAPE. Peripheral venous blood samples were collected during the acute onset stage and prior to any effective intervention.

Treatment groups

3,035 Participants
are divided into 13 treatment groups

13

Treatment groups

See each treatment group below.

Group A: HAPE: Calcium Channel Blocker (CCB) GroupNo intervention 0 interventions
Group B: HAPE:Glucocorticoid GroupNo intervention 0 interventions
Group C: HAPE:Diuretic GroupNo intervention 0 interventions
Group D: HAPE:Theophylline Drugs GroupNo intervention 0 interventions
Group E: HAPE:Combined Treatment GroupNo intervention 0 interventions
Group F: HACE:Osmotic Diuretic GroupNo intervention 0 interventions
Group G: HACE:Intensive Glucocorticoid Treatment GroupNo intervention 0 interventions
Group H: HACE:Combined Intracranial Pressure-Reducing Treatment GroupNo intervention 0 interventions
Group I: HACE:Other Adjuvant Drug GroupNo intervention 0 interventions
Group J: Multicenter Study of HAPE:Traditional Classic Treatment GroupExperimental treatment 2 interventions
Group K: Protocol for Proteomics and Peptidomics Study of HAPE:Control GroupExperimental treatment 1 intervention
Group L: HAPE DatabaseNo intervention 0 interventions
Group M: HACE DatabaseNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

HAPE:Recovery

Patients are defined as recovered only when all of the following criteria are met simultaneously: Resolution of clinical symptoms: complete relief of dyspnea (no shortness of breath at rest), disappearance of cough and expectoration, and resolution of chest tightness or chest pain. Restoration of normal physical signs: complete disappearance of lung crackles, resolution of cyanosis, and heart rate \< 100 beats per minute at rest. Normalization of physiological parameters: blood oxygen saturation (SpO₂) ≥ 90% above 3500 m altitude (≥ 88% above 4000 m altitude) and normal arterial blood gas analysis (if performed). Improvement on imaging studies: clear bilateral lung fields on chest X-ray, and resolution of alveolar exudation without significant effusion on chest CT. Meeting hospital discharge criteria: stable condition for more than 48 hours, recovery of self-care ability, and no requirement for continuous oxygen therapy.

Time frame
From date of disease onset to achievement of recovery criteria ,assessed up to 36 months
2

HACE :recovery

Patients are defined as recovered only when all of the following criteria are met simultaneously: Recovery of consciousness: Glasgow Coma Score (GCS) of 15, full restoration of orientation, and no signs of impaired consciousness. Resolution of neurological symptoms: complete relief of headache, and disappearance of ataxia, nausea, vomiting, blurred vision, and other related symptoms. Normal neurological signs: disappearance of pathological reflexes, negative meningeal irritation signs, and normal cranial nerve function. Improvement on imaging: resolution of cerebral edema, no mass effect, and normal ventricular system on head CT or MRI. Meeting hospital discharge criteria: stable condition for more than 72 hours, recovery of activities of daily living, and no requirement for special monitoring.

Time frame
From date of disease onset to achievement of recovery criteria ,assessed up to 36 months
3

Death

Death is defined as all-cause mortality occurring during hospitalization, or all-cause mortality within 30 days and 90 days after discharge.

Time frame
From admission to discharge, or all-cause mortality within 30 days and 90 days after discharge.
4

Length of hospital stay

From the first day of admission to the day of discharge

Time frame
The total duration from the first day of hospitalization to recovery and discharge, assessed up to 36 months

Secondary outcomes

1

HAPE:Improvement

Clinical symptoms improved by ≥50%, manifested as significant relief of dyspnea (no shortness of breath during mild activity), marked reduction in cough and expectoration, and alleviation of chest discomfort. Physiological indicators improved, including a decrease in heart rate by ≥20 beats per minute from baseline, an increase in blood oxygen saturation by ≥5% compared with admission, and a respiratory rate \< 24 breaths per minute. Imaging examinations showed a ≥50% reduction in pulmonary exudation on chest radiograph compared with admission, or a significant reduction in lesion extent on chest CT.

Time frame
At discharge(assessed up to 5 days)
2

Length of ICU/CCU stay

From the first day of admission to the day of discharge

Time frame
From date of the first day admimion in the ICU until the last day in the ICU, up to 48 weeks.
3

Duration of mechanical ventilation

Duration of mechanical ventilation, calculated in hours

Time frame
From the date of the first day of mechanical ventilation until the last day of mechanical ventilation,up to 48 weeks.
4

Total hospitalization cost (CNY)

total expenses incurred during hospitalization

Time frame
At discharge(assessed up to 5 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: