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NOT YET RECRUITING
NCT07343232

Correcting Hypocapnia in Aneurysmal Subarachnoid Hemorrhage.

Sponsor: The Chinese University of Hong Kong, Shenzhen

View on ClinicalTrials.gov

Summary

Based on the clinical observation that over half of the patients in the management of aneurysmal subarachnoid hemorrhage(aSAH) present with spontaneous hyperventilation, which is significantly associated with delayed cerebral ischemia and poor neurological outcomes, this prospective pilot study is designed to investigate the safety and efficacy of normobaric facemask oxygen for hypocapnia in aSAH.

Official title: Safety and Efficacy of Normobaric Facemask Oxygen for Hypocapnia in Aneurysmal Subarachnoid Hemorrhage(FOCAL): A Prospective, Multicenter, Proof-of-concept Pilot Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

80

Start Date

2026-01-01

Completion Date

2026-10-30

Last Updated

2026-01-15

Healthy Volunteers

No

Interventions

BEHAVIORAL

Normobaric Facemask Oxygen

Oxygen is to be delivered via a rebreathing facemask (ensuring no one-way valve is present), with a fractional inspired oxygen (FiO2) of 25-41% and an oxygen flow rate of ≤ 5 L/min. The goals are to maintain patient SpO2 \> 95%, PaCO2 between 35-42 mmHg, and, where feasible (particularly in centers with the capability for monitoring), an intracranial pressure (ICP) of \< 15 mmHg.

BEHAVIORAL

control group

Using nasal cannula for oxygen inhalation or not using oxygen inhalation at all. Monitor and record the patient's SpO2, systolic blood pressure, diastolic blood pressure, PaCO2, and also monitor the intracranial pressure (ICP) at a center with monitoring capabilities.

Locations (1)

School of Medicine Chinese University of Hong Kong-SHENZHEN

Shenzhen, Guangdong, China