MedDataX Logo

Therapeutic Hypercapnia After Aneurysmal Subarachnoid Hemorrhage - Optimum Duration of Hypercapnia

NCT ID: NCT04687605

Last Updated: 2020-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Temporary hypercapnia leads to a reproducible increase of cerebral blood flow (CBF) and brain tissue oxygenation (StiO2) as shown in a previous study (Trial-Identification: NCT01799525). The aim of this study now was to measure the course of carbon dioxide partial pressure (pCO2) reactivity after prolonged hypercapnia, and to evaluate the therapeutic effect of graded hypercapnia.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Cerebral vasospasm still is the leading cause of delayed cerebral ischemia (DCI) and secondary ischemic deficits after aneurysmal subarachnoid hemorrhage (SAH). Hypercapnia leads to a reproducible increase of cerebral blood flow (CBF) and brain tissue oxygenation (StiO2) as shown in a previous study (Trial-Identification: NCT01799525). Furthermore, the increase of CBF and StiO2 sustained after normalization of ventilation and no rebound effect was found. So, a possible optimization of the hypercapnic period may lead to prolonged effects of increased CBF and StiO2. Aim of this stuy is to find the ideal duration of hypercapnia and to evaluate the therapeutic effect of graded hypercapnia. For this, intubated and mechanically ventilated patients with an aneurysmal SAH Hunt/Hess 3-5, Fisher grade 2-4 on the initial CT scan and supplied with an external ventricular drainage will be included within the first 96 hours after ictus. Between day 4 and 14 they undergo a trial intervention in which the respiratory minute volume will be reduced in order to maintain a target PaCO2 of 50 - 55 mmHg for 2 hours. Arterial blood gas analysis (ABG) and transcranial Doppler sonography (TCD) is performed in 15-minute intervals. Intracranial pressure (ICP), cerebral perfusion pressure (CPP), and cardiovascular parameters are monitored continuously, serial measurement of CBF and StiO2 under continous hypercapnia is performed. Primary endpoint of this trial is change of CBF under hypercapnia, secondary endpoints are StiO2, measures non-invasively with near-infrared spectroscopy, mean flow velocity of intracranial vessels in TCD, delayed cerebral infarction in cranial CT and Glasgow Outcome Score (GOS) after 6 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vasospasm Intracranial

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

SAH Hypercapnia DCI

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Optimum duration of hypercapnia

Daily serial measurement of 2 hours under target hypercapnia of pCO2 50 - 55 mmHg by changes of respirator settings once per day

Group Type EXPERIMENTAL

Temporary hypercapnia

Intervention Type PROCEDURE

Temporary daily hypercapnia for 2 hours between day 4 and 14 after SAH

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Temporary hypercapnia

Temporary daily hypercapnia for 2 hours between day 4 and 14 after SAH

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Aneurysmal SAH
* Aneurysm occluded by clipping/coiling within 96 hours
* Hunt/Hess 3-5
* Fisher 2-4 on initial CT scan
* Intubated, sedated and mechanically ventilated patient
* Continous drainage of cerebrospinal fluid (CSF)

Exclusion Criteria

* Age under 18 years
* Pregnancy
* Common obstructive lung disease (COLD)
* potential of hydrogen (pH) in ABG \< 7,25
* ICP \> 20 mmHg
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Wuerzburg

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Stetter

Principial Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AZ230/14

Identifier Type: -

Identifier Source: org_study_id