Correcting Hypocapnia in Aneurysmal Subarachnoid Hemorrhage.
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Chinese University of Hong Kong, Shenzhen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years.
Confirmed diagnosis of aneurysmal subarachnoid hemorrhage (aSAH), with the presence of an aneurysm verified by computed tomography (CT), CT angiography (CTA), or digital subtraction angiography (DSA).
Hunt-Hess grade II-IV.
Presence of hypocapnia on arterial blood gas analysis, defined as PaCO2 < 35 mmH;
Disqualifiers
Presence of brain herniation or refractory intracranial hypertension, defined as a baseline intracranial pressure (ICP) > 25 mmHg that responds poorly to conventional ICP-lowering therapy;
Primary respiratory diseases (e.g., chronic obstructive pulmonary disease, severe asthma) known to cause chronically elevated baseline PaCO2;
Severe acid-base disturbances other than respiratory alkalosis.
Severe cardiac insufficiency, severe hepatic or renal dysfunction, malignant tumors, or other severe comorbidities that significantly impact prognosis;
Trial population
Aneurysmal Subarachnoid Hemorrhage Patients with Hypocapnia.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Normobaric Facemask Oxygen
BehavioralOxygen 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.
control group
BehavioralUsing 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Normobaric Facemask Oxygen1 intervention
Group B: Control group1 intervention
Trial outcomes
Primary outcomes
1
modified Rankin Scale (mRS) >3
The poor neurological outcome was considered to be mRs \>3, indicating severe disability or death. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. (Score Description: 0---No symptoms at all. 1---No significant disability despite symptoms; able to carry out all usual duties and activities. 2---Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance. 3---Moderate disability; requiring some help, but able to walk without assistance. 4--- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance. 5---Severe disability; bedridden, incontinent and requiring constant nursing care and attention. 6---Dead.
Time frame
90-day follow-up visit2
Incidence of delayed cerebral injury (DCI)
The presence of new focal neurological signs or a documented decrease in the level of consciousness persisting for at least 1 hour (or a drop of at least 1 point in the total Glasgow Coma Scale score), deemed to be of ischemic origin, after ruling out other causes (such as hydrocephalus, toxic-metabolic disturbances, or seizures); or identification of a new cerebral infarction on CT or MRI imaging.
Time frame
30 days after onsetSecondary outcomes
1
Montreal Cognitive Assessment (MoCA)
Cognitive function was evaluated using the Montreal Cognitive Assessment (MoCA), a standardized screening tool with scores ranging from 0 to 30, where higher scores indicate better cognitive performance and lower scores reflect greater cognitive impairment. Measure mean score or median compared between groups. And the rate of MoCA score of 20 or less between groups.
Time frame
90-day follow-up visit2
Cerebral Vasospasm
Incidence of moderate and severe radiographic cerebral vasospasm (catheter angiogram, CTA, MRA) or incidence OR moderate and severe vasospasm by transcranial doppler (TCD) criteria.
Time frame
Participants will be followed for the duration of the hospital stay, an expected average of 2 weeks3
Glasgow Coma Score(GCS)
The Glasgow Outcome Scale was used as secondary outcomes. The level of consciousness was assessed using the Glasgow Coma Scale (GCS), a standardized scale ranging from 3 to 15, where higher scores indicate a better neurological status (i.e., a higher level of consciousness), and lower scores reflect more severe impairment.
Time frame
Enrollment, 30 days after onset, and 90-day follow-up visit4
The modified Rankin Scale (mRS)
Shift analysis of mRS scores at 30 days after onset. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. (Score Description: 0---No symptoms at all. 1---No significant disability despite symptoms; able to carry out all usual duties and activities. 2---Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance. 3---Moderate disability; requiring some help, but able to walk without assistance. 4--- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance. 5---Severe disability; bedridden, incontinent and requiring constant nursing care and attention. 6---Dead. The higher scores indicate worse functional disability and lower scores reflect better functional independence.
Time frame
30 days after onsetSponsors and contacts
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Source ClinicalTrials.gov
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