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Head Position on Cerebral Haemodynamics in Acute Ischemic Stroke and Controls

2020年1月29日 更新者:University of Leicester

The Effects of Head Positioning on Beat to Beat Cerebral Haemodynamics: a Comparison Between Acute Stroke Patients and Healthy Control Subjects

Cerebral autoregulation is an important mechanism whereby cerebral perfusion is normally maintained at a constant level, over a relatively wide blood pressure range. It can be assessed noninvasively by the use of Trans Cranial Doppler (TCD). This means using ultrasound probes over both sides of the head to measure changes in blood flow in one of the main brain arteries (the middle cerebral artery) in response to beat to beat changes in blood pressure dynamic cerebral autoregulation (dCA). It is established that dCA is impaired following moderate to severe stroke, acting as a key role in the development of secondary brain damage related to brain swelling and further damage related to the low blood flow. The administration of clot busting therapy (thrombolysis), one of the main approved treatments of acute ischaemic stroke (AIS), results in recanalisation of the blocked artery in only approximately 50% of patients. Therefore, as well as attempts to treat major vessel blockage, improving brain blood flow, particularly to the penumbral area, through arteries that bypass the blockage is another potential therapeutic approach in AIS.One simple way of achieving this might be to lower the head of AIS patient into a lying flat (0⁰) position. However, to date, there have been very few studies exploring this. This research will use the noninvasive technique of Trans Cranial Doppler (TCD) to see how blood flow changes in different head positions, both in healthy volunteers and AIS patient. This study will provide important data regarding blood pressure management in acute stroke, an important and common clinical dilemma.

調査の概要

状態

完了

詳細な説明

In the United Kingdom (UK) alone, approximate 100,000 people suffer a stroke each year. Improved management of stroke patients not only reduces morbidity and mortality, but also reduces the cost of long term social care.

The brain has control systems (i.e.cerebral autoregulation) to maintain blood flow to the brain, over a relatively wide blood pressure range. Cerebral Autoregulation can be described as static, reflecting the integrity of such mechanisms over time, or dynamic, occurring in response to sudden fluctuations in perfusion pressure. When blood pressure drops, small arteries increase in size to restore flow levels, and when blood pressure rises, they narrow to protect the most delicate blood vessels. It is known that sudden decompensated blood pressure (BP) changes can occur after stroke, this could result in brain bleeding and swelling when there is uncontrolled increased blood flow, or reduce the viability of tissue surrounding the stroke area when there is reduced blood flow to the brain.

It is known that the clot busting agent (Alteplase), the main effective treatment used in the acute stroke can only improve blood flow in already blocked arteries in 50% of patients. Therefore, as well as attempts to treat blockage of major vessel, improving the blood flow through vessel that bypass the blocked vessel around the stroke area (penumbra) could be another potential therapeutic approach in acute ischaemic stroke patients. A simple way of increase blood flow to these penumbral area might be just lower the head of acute stroke patients into a lying flat position. Several observational studies have investigated the effects of head positioning on blood flow to the brain in a healthy population, however few studies carried out on acute ischaemic stroke patients so far.

Cerebral autoregulation can be assessed non-invasively by the use of Trans Cranial Doppler (TCD). This means using ultrasound probes over both sides of the head to measure changes in blood flow in one of the main brain arteries (the middle cerebral artery) in response to beat to beat changes in blood pressure dynamic cerebral autoregulation. This research will use the noninvasive technique of Trans Cranial Doppler to see how blood flow changes during different head position between acute ischaemic stroke patients and healthy controls, as well as over time during recovery after a stroke. This knowledge will help us to understand the changes in brain blood flow control and blood pressure in stroke patients, with implications of diagnosis, prognosis, and treatment of the disease.

研究の種類

観察的

入学 (実際)

51

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Leicester、イギリス、LE1 5WW
        • University Hosptial of Leicester NHS Trust

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

サンプリング方法

確率サンプル

調査対象母集団

11 healthy control subjects 11 acute ischaemic stroke patient 11 acute ischaemic stroke patients in the lying flat (0 degree) head position (first 24 hours of hospital admission) 11 acute ischaemic stroke patients in the sitting up ( 30 degree) head position (first 24 hours of hospital admission)

説明

Inclusion Criteria:

- Informed volunteer consent, patient consent or personal consultee declaration form

  • 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 Stroke Patient-specific Inclusion Criteria
  • Clinical diagnosis of ischaemic stroke within 24 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)

Exclusion Criteria:

  • Male or Female, aged under 18 years

    • Unable (in the Investigator's opinion) or unwilling to comply with any study requirements
    • Participants who practice yoga regularly
    • Female participants who are pregnant, lactating or planning pregnancy during the course of the study Stroke Patient-specific Exclusion Criteria
    • Clinical diagnosis of stroke greater than 24 hours from onset
    • Having had a resolved transient ischaemic attack (TIA) (i.e. neurological symptoms completely resolved upon hospital presentation)
    • Definite clinical indication to 'sitting up' (≥30⁰) head position (i.e. pneumonia, decompensated heart failure)
    • Definite clinical indication to lying flat (0⁰) head position (i.e. shock, airways obstruction)
    • Co-morbidity with anticipated life expectancy less than 3 months

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Healthy controls
healthy controls subjects who have age, sex and Blood pressure matched with the acute ischaemic stroke patient
patient can be allocated to the transient change of the head position, persistent lying flat position in the first 24 hours of the hospital admission and persistent sitting up in the first 24 hours of the hospital admission
AIS patient-transient arm
transient change of head position from lying flat (0 degree) to sitting up (30 degree)
patient can be allocated to the transient change of the head position, persistent lying flat position in the first 24 hours of the hospital admission and persistent sitting up in the first 24 hours of the hospital admission
AIS patient - persistent lying flat
lying flat (0 degree) head position for the first 24 hours in the hospital admission
patient can be allocated to the transient change of the head position, persistent lying flat position in the first 24 hours of the hospital admission and persistent sitting up in the first 24 hours of the hospital admission
AIS patient - persistent sitting up
sitting up ( 30 degree) head position for the first 24 hours in the hospital admission
patient can be allocated to the transient change of the head position, persistent lying flat position in the first 24 hours of the hospital admission and persistent sitting up in the first 24 hours of the hospital admission

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
cerebral blood flow velocity
時間枠:within 24 hours, 72 hours and 3 months of the stroke symptom onset
percentage change of the cerebral blood flow velocity in response to change of the head position within 24 hours, 72 hours and 3 months of the stroke symptom onset
within 24 hours, 72 hours and 3 months of the stroke symptom onset

二次結果の測定

結果測定
メジャーの説明
時間枠
dynamic cerebral autoregulation
時間枠:within 24 hours, 72 hours and 3 months of stroke symptom onset
change of dynamic cerebral autoregulation within 24 hours, 72 hours and 3 months of the stroke symptom onset.
within 24 hours, 72 hours and 3 months of stroke symptom onset
Neurovascular coupling
時間枠:within 24 hours, 72 hours and 3 months of stroke symptom onset
change of neurovascular coupling within 24 hours, 72 hours and 3 months of stroke symptom onset
within 24 hours, 72 hours and 3 months of stroke symptom onset
Carbon dioxide reactivity
時間枠:within 24 hours, 72 hours and 3 months of stroke symptom onset
change of carbon dioxide reactivity within 24 hours, 72 hours and 3 month of stroke symptom onset.
within 24 hours, 72 hours and 3 months of stroke symptom onset

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Thompson G Robinson, MD, FRCP、University of Leicester

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2015年11月1日

一次修了 (実際)

2017年3月31日

研究の完了 (実際)

2017年3月31日

試験登録日

最初に提出

2016年10月6日

QC基準を満たした最初の提出物

2016年10月10日

最初の投稿 (見積もり)

2016年10月13日

学習記録の更新

投稿された最後の更新 (実際)

2020年1月30日

QC基準を満たした最後の更新が送信されました

2020年1月29日

最終確認日

2016年5月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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