Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07343232
Brief 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.
Detailed Description:
Spontaneous hyperventilation (SH) is highly prevalent following aneurysmal subarachnoid hemorrhage (aSAH) and is significantly associated with poor neurological outcomes.The core pathophysiological mechanism involves hypocapnia induced by hyperventilation, which triggers cerebral vasoconstriction and consequently leads to a decrease in cerebral blood flow (CBF).Although this response may transiently reduce intracranial pressure, persistent cerebral vasoconstriction markedly increases the risk of delayed cerebral ischemia (DCI) and secondary brain injury. Therefore, maintaining the arterial partial pressure of carbon dioxide (PaCO2) within the physiological range of mmHg is recommended to minimize the detrimental effects of hypocapnia.
Currently, there is a lack of standardized management strategies for hypocapnia resulting from SH after aSAH. Based on physiological principles, low-flow (\<5 L/min) oxygen delivery via a facemask may effectively correct hypocapnia by promoting the rebreathing of carbon dioxide within the dead space of the facemask.10 A randomized controlled trial investigating psychogenic hyperventilation syndrome provides preliminary evidence for this approach, demonstrating that low-flow (3 L/min) facemask oxygen therapy can relieve symptoms more rapidly and improve patient comfort compared to traditional breathing training.11
However, high-level evidence regarding the safety, efficacy, and impact on neurological outcomes of using low-flow facemask oxygen therapy (functioning as a rebreathing mask) as a targeted intervention for correcting hypocapnia in aSAH patients remains scarce. Consequently, this proof-of-concept prospective study aims to systematically evaluate the operational safety and clinical effectiveness of rebreathing facemask oxygen therapy for correcting hypocapnia in patients with aSAH.
Study:
NCT07343232
Study Brief:
Protocol Section:
NCT07343232