Clinical Trials Directory

Trials / Completed

CompletedNCT03324321

Feasibility of Improving Cerebral Autoregulation in Acute Intracerebral Haemorrhage

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
18 (actual)
Sponsor
University of Leicester · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHERHypocapnia via Hyperventilation Protocol90 seconds of hyperventilation using a metronome to lower levels of -5mmHg and -10mmHg below baseline EtCO2

Timeline

Start date
2017-10-08
Primary completion
2018-07-15
Completion
2018-07-15
First posted
2017-10-27
Last updated
2018-10-31

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03324321. Inclusion in this directory is not an endorsement.