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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Severe High Altitude Pulmonary Edema; Severe High Altitude Cerebral Edema
• Intervention / Treatment: Device: Multicenter study of HAPE：CPAP or BiPAP Group; Drug: Multicenter study of HAPE group：NO Group; Other: Protocol for Proteomics and Peptidomics Study of HAPE：Case Group

• Study Type: Interventional
• Enrollment (Estimated): 3035
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gesang Luobu, MD; Phone Number: 8618108912487; Email: kelsangnorbu@hotmail.com

Study Locations

• China
  • Tibet
    • Lhasa, Tibet, China, 850000
      • Xizang Autonomous Region People's Hospital
      • Contact: li hui Yang; Phone Number: 13638992795; Email: 1640794768@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. History of severe cardiopulmonary diseases.
2. 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.
3. Patients with malignant tumors, severe hepatic or renal insufficiency, or immune system diseases requiring immunosuppressive therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

13

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: HAPE： Calcium Channel Blocker (CCB) Group; Calcium Channel Blocker (CCB) Group: Nifedipine sustained-release tablets: 30-60 mg/day, orally in 2-3 divided doses;
No Intervention: HAPE：Glucocorticoid Group; Dexamethasone: 8-16 mg/day, intravenous injection, tapering off after 3-5 days; Methylprednisolone: 40-80 mg/day, intravenous injection; Prednisone: 40-60 mg/day, oral administration;
No Intervention: HAPE：Diuretic Group; Furosemide: 40-80 mg/day, administered intravenously or orally; Spironolactone: 40-80 mg/day, administered orally; Note: Strictly monitor electrolytes and renal function.
No Intervention: HAPE：Theophylline Drugs Group; Aminophylline: 0.25-0.5g, intravenous drip, 1-2 times a day; Doxofylline: 200mg, intravenous drip, 2 times a day;
No Intervention: HAPE：Combined Treatment Group; CCB + Glucocorticoid: Nifedipine + Dexamethasone; Glucocorticoid + Diuretic: Dexamethasone + Furosemide; Triple Therapy: CCB + Glucocorticoid + Diuretic.
No Intervention: HACE：Osmotic Diuretic Group; 0.5-1.0 g/kg, rapid intravenous infusion, once every 6-8 hours; Hypertonic saline: 3% sodium chloride solution, 250 ml intravenous infusion. Monitoring indicators: intracranial pressure, blood osmotic pressure, renal function.
No Intervention: HACE：Intensive Glucocorticoid Treatment Group; High-dose dexamethasone: 16-32 mg/day, intravenously; Methylprednisolone pulse therapy: 500-1000 mg/day for 3 days, followed by dosage tapering. Treatment course: 7-10 days with gradual dose reduction.
No Intervention: HACE：Combined Intracranial Pressure-Reducing Treatment Group; Mannitol + Glucocorticoid: Mannitol 0.5 g/kg + Dexamethasone 16 mg/day; Hypertonic saline + Glucocorticoid: 3% NaCl + Methylprednisolone; Triple therapy: Mannitol + Glucocorticoid + Diuretic.
No Intervention: HACE：Other Adjuvant Drug Group; Furosemide: 20-40 mg/day to reduce cerebral edema; Albumin: 25% albumin 50 ml to increase plasma colloid osmotic pressure; Sodium aescinate: 20-40 mg/day to improve vascular permeability.
Experimental: Multicenter Study of HAPE：Traditional Classic Treatment Group; Oxygen inhalation plus CCB or aminophylline	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)
Experimental: Protocol for Proteomics and Peptidomics Study of HAPE：Control Group; 40 healthy individuals who are either migrant residents or indigenous residents at high altitude. Age, gender, and residential altitude were strictly matched. Peripheral venous blood samples were collected during the same period.	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.
No Intervention: HAPE Database; To establish a High-Altitude Pulmonary Edema (HAPE) Database (≥1000 cases) through a multicenter retrospective study.
No Intervention: HACE Database; To establish a High-Altitude Pulmonary Edema (HACE) Database (≥400 cases) through a multicenter retrospective study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From date of disease onset to achievement of recovery criteria ,assessed up to 36 months
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.	From date of disease onset to achievement of recovery criteria ,assessed up to 36 months
Death	Death is defined as all-cause mortality occurring during hospitalization, or all-cause mortality within 30 days and 90 days after discharge.	From admission to discharge, or all-cause mortality within 30 days and 90 days after discharge.
Length of hospital stay	From the first day of admission to the day of discharge	The total duration from the first day of hospitalization to recovery and discharge, assessed up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At discharge(assessed up to 5 days)
Length of ICU/CCU stay	From the first day of admission to the day of discharge	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	Duration of mechanical ventilation, calculated in hours	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)	total expenses incurred during hospitalization	At discharge(assessed up to 5 days)
Time to independence from oxygen therapy (days)	Duration of oxygen therapy during hospitalization (days)	At discharge(assessed up to 5 days)
HAPE：incidence of complications	such as pulmonary embolism, pneumothorax, infection, etc	From date of admission until the date of discharge, and within 30 days and 90 days after discharge,up to 48 weeks.
HACE：improved	A patient is defined as having "improved" if meeting the following core criteria: Improved consciousness: Glasgow Coma Scale (GCS) score increased by ≥3 points from admission, partial recovery of orientation, and improved response to stimuli. Improved neurological symptoms: ≥50% reduction in headache severity (VAS score), significant improvement in ataxia, and decreased nausea and vomiting. Improved physiological indicators: heart rate decreased by ≥15 beats per minute from baseline, blood oxygen saturation increased by ≥5% compared with admission, and blood pressure controlled within the normal range.	At discharge(assessed up to 5 days)
HACE：Incidence of complications	such as seizures, intracranial infection, brain herniation, permanent neurological deficit	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	specifically categorized as: 0 (no symptoms),; (no significant disability),; (slight disability),; (moderate disability),; (moderately severe disability),; (severe disability), and 6 (death).	From the first day of admission to 90 days thereafter

Collaborators and Investigators

• Sponsor: Tibet Autonomous Region People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 20, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: May 14, 2026
• First Submitted That Met QC Criteria: June 7, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 7, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: High altitude; Key Diagnostic; Therapeutic Technologies; Severe Acute High Altitude Disease (SAHAD)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Altitude Sickness; Health Care Quality, Access, and Evaluation; Therapeutics; Health Care Evaluation Mechanisms; Quality of Health Care; Epidemiologic Study Characteristics; Clinical Protocols
• Other Study ID Numbers: ME-TBHP-25-090

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: No
• product manufactured in and exported from the U.S.: No