Severe High Altitude Cerebral Edema, Severe High Altitude Pulmonary Edema
Conditions
Keywords
High altitude, Key Diagnostic, Therapeutic Technologies, Severe Acute High Altitude Disease (SAHAD)
Brief summary
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
DEVICEMulticenter study of HAPE：CPAP or BiPAP Group
Traditional treatment plus CPAP or BiPAP
DRUGMulticenter study of HAPE group：NO Group
Traditional treatment plus inhaled nitric oxide therapy (20-40 ppm, continuous administration for 12-24 hours)
OTHERProtocol 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.
Sponsors
Tibet Autonomous Region People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HAPE：Recovery | From date of disease onset to achievement of recovery criteria ,assessed up to 36 months | 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. |
| HACE ：recovery | From date of disease onset to achievement of recovery criteria ,assessed up to 36 months | 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. |
| Death | From admission to discharge, or all-cause mortality within 30 days and 90 days after discharge. | Death is defined as all-cause mortality occurring during hospitalization, or all-cause mortality within 30 days and 90 days after discharge. |
| Length of hospital stay | The total duration from the first day of hospitalization to recovery and discharge, assessed up to 36 months | From the first day of admission to the day of discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HAPE：Improvement | At discharge(assessed up to 5 days) | 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. |
| Length of ICU/CCU stay | From date of the first day admimion in the ICU until the last day in the ICU, up to 48 weeks. | From the first day of admission to the day of discharge |
| Duration of mechanical ventilation | From the date of the first day of mechanical ventilation until the last day of mechanical ventilation,up to 48 weeks. | Duration of mechanical ventilation, calculated in hours |
| Total hospitalization cost (CNY) | At discharge(assessed up to 5 days) | total expenses incurred during hospitalization |
| Time to independence from oxygen therapy (days) | At discharge(assessed up to 5 days) | Duration of oxygen therapy during hospitalization (days) |
| HAPE：incidence of complications | From date of admission until the date of discharge, and within 30 days and 90 days after discharge,up to 48 weeks. | such as pulmonary embolism, pneumothorax, infection, etc |
| HACE：improved | At discharge(assessed up to 5 days) | 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. |
| HACE：Incidence of complications | From date of admission until the date of discharge, and within 30 days and 90 days after discharge,up to 48 weeks. | such as seizures, intracranial infection, brain herniation, permanent neurological deficit |
| HACE：Modified Rankin Scale (mRS) score at 90 days | From the first day of admission to 90 days thereafter | specifically categorized as: 0 (no symptoms), 1. (no significant disability), 2. (slight disability), 3. (moderate disability), 4. (moderately severe disability), 5. (severe disability), and 6 (death). |
Countries
China
Contacts
CONTACTGesang Luobu, MD
Outcome results
None listed