Feasibility of Improving Cerebral Autoregulation in Acute Intracerebral Haemorrhage

Not Applicable

Completed

• Conditions: Blood Pressure; Cerebral Brain Hemorrhage; Stroke, Acute; Hemorrhage
• Interventions: Other: Hypocapnia via Hyperventilation Protocol

• Registration Number: NCT03324321
• Lead Sponsor: University of Leicester

Brief Summary

In the UK, 23,000 (15%) of the 150,000 people who suffer a stroke each year have bleeding in the brain, also referred to as acute intracerebral haemorrhage (ICH). An Autoregulation Index (ARI) can be assigned between 0 and 9 (0 being poor and 9 being the most efficient CA observed) to gauge how good the control over blood flow is at a given time. Dynamic CA (dCA) is a measure of the response of cerebral blood flow (CBF) to rapid changes in blood pressure (BP), and several key studies have shown impaired dCA post-acute ICH. The most recent study demonstrated that dCA impairment lasts up to 12 days. This is particularly important to understand, since our preliminary work has recently shown that changes in carbon dioxide using simple breathing exercises can improve Autoregulation.

Unfortunately, there are limited non-pharmacological management options and significant opportunities to improve patient outcome in ICH. The proposed study addresses this area, by investigating whether a simple breathing exercise in survivors of ICH is safe, feasible and effective in reducing brain injury by improving cerebral autoregulation.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-08
• Study First Submitted: 2017-10-09
• Study First Submitted QC: 2017-10-24
• Study First Posted: 2017-10-27
• Primary Completion: 2018-07-15
• Study Completion: 2018-07-15
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-30
• Last Update Posted: 2018-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Clinical diagnosis of a haemorrhagic stroke within 48 hours of onset (for patients waking with a stroke, time of onset will be taken to be the time when the patient was last asymptomatic)
• Able and willing to give informed consent
• Male or female, aged 18 years or above
• Able (in the Investigator's opinion) and willing to comply with all study requirements
• Willing to allow his or her General Practitioner (GP) to be notified of participation in the study

Exclusion Criteria

• Male or Female, aged under 18 years
• Significant previous airways disease (formal diagnosis of moderate or severe airways disease and having treatment for this respiratory condition - via inhalers or specialist input)
• Unable (in the Investigator's opinion) or unwilling to comply with any study requirements
• Female participants who are pregnant, lactating or planning pregnancy during the course of the study
• Clinical diagnosis of stroke greater than 48 hours from onset
• Having had a resolved transient ischaemic attack (TIA) (i.e. neurological symptoms completely resolved upon hospital presentation)
• Co-morbidity with anticipated life expectancy less than 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hyperventilation Protocol	Hypocapnia via Hyperventilation Protocol	This will involve sustained periods of 90-seconds of hyperventilation at two levels (-5mmHg and -10mmHg below baseline EtCO2) to a maximum lower level threshold of EtCO2 24mmHg/CBFV 33cm/s regulated using a metronome. Two-minute washout periods of normal respiration will be allowed between successive measurements. Each incremental reduction in pCO2 will be repeated on two occasions during the same session. Further assessments will be conducted 10-14 days following baseline assessments.

Primary Outcome Measures

Name	Time	Method
Post Stroke Morbidity and Mortality	14 days	Determined using Modified Rankin Scale 0 - No symptoms; 1. - No significant disability, despite symptoms; able to perform all usual duties and activities; 2. - Slight disability; unable to perform all previous activities but able to look after own affairs without assistance; 3. - Moderate disability; requires some help, but able to walk without assistance; 4. - Moderate severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5. - Severe disability; bedridden, incontinent, and requires constant care 6- Death
The percentage of measurements rejected because of aspects related to data quality during the analysis protocol, with recorded reasons	14 days
The percentage of recruited subjects in whom values for the following cerebral haemodynamic parameters can be derived	14 days	* % change in CBFv at baseline and in response to a hyperventilation manoeuvre in the acute (\<48 hours) and sub-acute (10 to 14 days) periods; * Autoregulation index; * % change in CBFv at baseline and in response to a hyperventilation manoeuvre in the acute (\<48 hours) and sub-acute (10 to 14 days) periods; * Autoregulation index
The percentage of recruited subjects able to comply with the full measurement protocol	14 days

Trial Locations

Locations (1)

University Hospitals of Leicester NHS Trust; 🇬🇧 Leicester, United Kingdom