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

Capital Medical University

Status: Unknown

Conditions: Aneurysmal Subarachnoid Hemorrhage

Treatments: Device: Hydrogen Oxygen Generator with Nebulizer

Study type: Interventional

Funder types: Other

Identifiers

NCT05282836

HX-A-2021016

Details and patient eligibility

About

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.

Enrollment: 206 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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206 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Device: Hydrogen Oxygen Generator with Nebulizer

No intervention

No Intervention group

Description:

Usual care refers to the standard-of-care (including oxygen therapy) recommended by guidelines.