Early Hydrogen-Oxygen Gas Mixture Inhalation in Patients With Aneurysmal Subarachnoid Hemorrhage (HOMA)

Not Applicable

• Conditions: Aneurysmal Subarachnoid Hemorrhage
• Interventions: Device: Hydrogen Oxygen Generator with Nebulizer

• Registration Number: NCT05282836
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

This was a randomized, single-center trial. On the basis of standard-of-care, patients in the treatment group inhaled H2-O2 (66% hydrogen; 33% oxygen) at 3 L/min via nasal cannula by using the Hydrogen/Oxygen Generator (model AMS-H-03, Shanghai Asclepius Meditech Co., Ltd., China) during a 7-day stay in the intensive care unit. Patients in the control group received standard-of-care (consisting of oxygen therapy) alone. This study intends to apply Hydrogen/Oxygen Generator in clinical patients with aneurysmal subarachnoid hemorrhage (aSAH), exploring the role of hydrogen-oxygen mixed gas inhalation therapy in early brain injury, and the prevention of cerebral vasospasm and delayed cerebral ischemia, finally providing a scientific basis for hydrogen treatment of aSAH.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-03-08
• Last Update Submitted: 2022-03-08
• Study Start: 2022-03-15
• Study First Posted: 2022-03-16
• Last Update Posted: 2022-03-16
• Primary Completion: 2023-03-15
• Study Completion: 2024-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

1. Age ≥ 18 years
2. Signed informed consent
3. Must be admitted within 72 hours after aneurysm rupture

Exclusion Criteria

1. physical disability caused by any reason before the onset of the disease
2. dementia or mental illness before the onset of the disease
3. more than 72 hours after aneurysm rupture admitted to hospital for treatment
4. do not cooperate with the treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Hydrogen Oxygen Generator with Nebulizer	H2-O2 (66% hydrogen; 33% oxygen) inhalation. Patients in the treatment group inhaled H2-O2 (66% hydrogen; 33% oxygen) at 3 L/min via nasal cannula by using the Hydrogen/Oxygen Generator (model AMS-H-03, Shanghai Asclepius Meditech Co., Ltd., China) during a 7-day stay in the intensive care unit.

Primary Outcome Measures

Name	Time	Method
In- hospital Cerebral Vasospasm	From baseline to 14 days	The proportion of patients with cerebral vasospasm at day 14
In- hospital Delayed Cerebral Ischemia	From baseline to 14 days	The proportion of patients with delayed cerebral ischemia at day 14

Secondary Outcome Measures

Name	Time	Method
modified Rankin Scale score	90 days after discharge	modified Rankin Scale score at 90 days after discharge
Montreal Cognitive Assessment score	90 days after discharge	Montreal Cognitive Assessment score at 90 days after discharge