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Completed

NCT Number: NCT03324321

Feasibility of Improving Cerebral Autoregulation in Acute Intracerebral Haemorrhage

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.

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Key information

Conditions

Stroke, Acute Blood Pressure Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Brain Hemorrhage Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypocapnia via Hyperventilation Protocol

Other

90 seconds of hyperventilation using a metronome to lower levels of -5mmHg and -10mmHg below baseline EtCO2

Primary outcomes

  1. Post Stroke Morbidity and Mortality

    Time frame: 14 days

    Determined using Modified Rankin Scale 0 - No symptoms

    • - No significant disability, despite symptoms; able to perform all usual duties and activities
    • - Slight disability; unable to perform all previous activities but able to look after own affairs without assistance
    • - Moderate disability; requires some help, but able to walk without assistance
    • - Moderate severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
    • - Severe disability; bedridden, incontinent, and requires constant care 6- Death

  2. The percentage of recruited subjects able to comply with the full measurement protocol

    Time frame: 14 days

  3. The percentage of measurements rejected because of aspects related to data quality during the analysis protocol, with recorded reasons

    Time frame: 14 days

  4. The percentage of recruited subjects in whom values for the following cerebral haemodynamic parameters can be derived

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Registry information

Official study title

Feasibility of Improving Cerebral Autoregulation in Acute Intracerebral Haemorrhage (BREATHE-ICH) Study

Acronym: BREATHE-ICH

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 27, 2017
Registry last updated
Oct 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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