Feasibility of Improving Cerebral Autoregulation in Acute Intracerebral Haemorrhage

NCT ID: NCT03324321

Last Updated: 2018-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-08
• Study Completion Date: 2018-07-15

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.

Conditions

Stroke, Acute; Hemorrhage; Cerebral Brain Hemorrhage; Blood Pressure

Keywords

Cerebral Haemodynamics; Carbon Dioxide; Cerebral Autoregulation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Hypocapnia via Hyperventilation Protocol

Intervention Type: OTHER

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

Interventions

Hypocapnia via Hyperventilation Protocol

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Leicester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thompson G Robinson, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

University of Leicester

Locations

University Hospitals of Leicester NHS Trust

Leicester, , United Kingdom

Countries

United Kingdom

References

Tiecks FP, Lam AM, Aaslid R, Newell DW. Comparison of static and dynamic cerebral autoregulation measurements. Stroke. 1995 Jun;26(6):1014-9. doi: 10.1161/01.str.26.6.1014.

Reference Type: BACKGROUND

PMID: 7762016 (View on PubMed)

Ma H, Guo ZN, Liu J, Xing Y, Zhao R, Yang Y. Temporal Course of Dynamic Cerebral Autoregulation in Patients With Intracerebral Hemorrhage. Stroke. 2016 Mar;47(3):674-81. doi: 10.1161/STROKEAHA.115.011453. Epub 2016 Feb 4.

Reference Type: BACKGROUND

PMID: 26846864 (View on PubMed)

Minhas JS, Panerai RB, Swienton D, Robinson TG. Feasibility of improving cerebral autoregulation in acute intracerebral hemorrhage (BREATHE-ICH) study: Results from an experimental interventional study. Int J Stroke. 2020 Aug;15(6):627-637. doi: 10.1177/1747493019873690. Epub 2019 Sep 9.

Reference Type: DERIVED

PMID: 31500552 (View on PubMed)

Minhas JS, Panerai RB, Robinson TG. Feasibility of Improving Cerebral Autoregulation in Acute Intracerebral Haemorrhage (BREATHE-ICH) study: a protocol for an experimental interventional study. BMJ Open. 2018 Mar 27;8(3):e020758. doi: 10.1136/bmjopen-2017-020758.

Reference Type: DERIVED

PMID: 29593024 (View on PubMed)

Study Documents

Document Type: Funder

View Document

Other Identifiers

0624

Identifier Type: -

Identifier Source: org_study_id