Stroke, IschemicNCT04804085
Anaesthesia for Mechanical Thrombectomy
An observational study of Stroke, Ischemic and Anesthesia, run by Nottingham University Hospitals NHS Trust.
Trial summary
Title: Conduct of anaesthesia during acute ischaemic stroke: a retrospective case series of patients undergoing mechanical thrombectomy. Design: This study will be a retrospective consecutive observational case series Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Anesthesia
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be identified by existing clinical records of mechanical thrombectomy procedures undertaken at Nottingham University Hospitals and already collated as part of routine service evaluation and clinical care. Sampling will be consecutive. The sampling window (01/01/2016-01/10/2020) has been chosen because mechanical thrombectomy is a new therapy that was not undertaken in current form before 2016.
Who may be able to join
- Age ≥ 18 years old
- Undergone mechanical thrombectomy for the management of acute ischaemia stroke between 01/01/2016-01/10/2020 at Nottingham University Hospitals NHS Trust.
Who cannot join
- No pre-specified exclusion criteria.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Conduct of Anaesthesia During Acute Ischaemia Stroke: a Retrospective Case Series of Patients Undergoing Mechanical Thrombectomy
Title: Conduct of anaesthesia during acute ischaemic stroke: a retrospective case series of patients undergoing mechanical thrombectomy.
Design: This study will be a retrospective consecutive observational case series
Read the detailed description
The Aim of this study is to describe the baseline characteristics, procedural and post-operative clinical characteristics of anaesthetic care delivered to consecutive adult patients who underwent mechanical thrombectomy as part of their routine clinical care between 01/01/2016 and 01/10/2020 at Nottingham University Hospitals NHS Trust (sample size approximately 250).
- Conditions
- Stroke, Ischemic, Anesthesia
- Keywords
- Anaesthesia, Ischaemic, Mechanical, Case Series, Endovascular, Thrombectomy, Stroke
- Medical subject headings
- Ischemic Stroke, Ischemia, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the number of patients requiring mechanical thrombectomy
This retrospective study will identify the anaesthetic care delivered to a group of patients undergoing mechanical thrombectomy for the management of acute ischaemic stroke. The data collected will be from all patients that received this treatment between 01/01/2016 and 01/10/2020 at Nottingham University Hospitals NHS Trust. This data written up and of interest both to our organisation and to comparable neuroscience centres in the UK and internationally.
Outcomes that will be measured in this clinical case study are highlighted below.
Measured: Through study completion, up to 9 months
Secondary outcomes (24)
Background information: Age (>/= 18 years of age)
Measured: Through study completion, up to 9 months
Background information: Gender (male or female)
Physiological gender
Measured: Through study completion, up to 9 months
Background information: The degree of disability/dependence after a stroke will be measured using the presenting modified Rankin Score
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
Measured: Through study completion, up to 9 months
Background information: Presenting blood pressure (systolic and diastolic)
Measured: Through study completion, up to 9 months
Background information: Presenting heart rate (beats per minute)
Measured: Through study completion, up to 9 months
Background information: The fitness of the patient will be measured using the American Society of Anaesthetists Classification
ASA I A normal healthy patient Healthy ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease ASA IV A patient with severe systemic disease that is a constant threat to life ASA V A moribund patient who is not expected to survive without the operation ASA VI A declared brain-dead patient whose organs are being removed for donor purposes
Measured: Through study completion, up to 9 months
Background information: Height of the patient (m)
BMI = Weight / (height x height)
Measured: Through study completion, up to 9 months
Background information: Weight of the patient (kg)
BMI = Weight / (height x height)
Measured: Through study completion, up to 9 months
Background information: Measuring the distance from referring hospital (miles)
Hospitals included: Kings Mill Hospital, Royal Derby Hospital, Leicester, Lincoln, Boston, Burton
Measured: Through study completion, up to 9 months
The patient's stroke classification will be measured using National Institute for Health Stroke Scale
1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke
Measured: Through study completion, up to 9 months
Mode of anaesthesia
Awake / Sedated / Converted on-table to General Anaesthetic / GA.
Measured: Through study completion, up to 9 months
To identify the anaesthetic agents used
Propofol / Alfentanil / Remifentanil / Fentanyl / Midazolam
Measured: Through study completion, up to 9 months
The level of the anaesthetist (registrar / consultant)
Measured: Through study completion, up to 9 months
Intra - procedural observations: Measuring time spent with systolic blood pressure (mmHg) <10% of presenting BP (minutes)
Measured: Through study completion, up to 9 months
Intra - procedural observations: Quantifying any episodes of hypoxia (SpO2 <94%)
Measured: Through study completion, up to 9 months
Intra-procedural interventions: Identifying if the patient required vasopressors
None / metaraminol / ephedrine / noradrenaline
Measured: Through study completion, up to 9 months
Measuring the response of treatment using the post-procedural Thrombolysis in Cerebral Infarction scale
Grade 0: no perfusion Grade 1: penetration with minimal perfusion Grade 2: partial perfusion Grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualised Grade 2B: complete filling of all of the expected vascular territory is visualised but the filling is slower than normal Grade 3: complete perfusion
Measured: Through study completion, up to 9 months
To identify the level of care required immediately post procedure (Level 0,1,2,3)
Measured: Through study completion, up to 9 months
Identify the duration of Intensive Care stays (days)
Measured: Through study completion, up to 9 months
Identify the duration of stay in hospital (days)
Whether in NUH or otherwise
Measured: Through study completion, up to 9 months
To measure the long term outcome: National Institute for Health Stroke Scale at 24 hours post-procedure
1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke
Measured: Through study completion, up to 9 months
To measure the long term outcome: Modified Rankin Score at 90 days
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
Measured: Through study completion, up to 9 months
To measure the long term outcome: Mortality at 90 days (survived / deceased)
Measured: Through study completion, up to 9 months
To measure the long term outcome: Discharge destination (home / institution)
Measured: Through study completion, up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Hewson (Consultant Anaesthetist), Principal investigator, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804085
- Sponsor's protocol ID
- 20AN004
- Status last verified
- Mar 2021
- First submitted
- 9 Nov 2020
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conduct of Anaesthesia During Acute Ischaemia Stroke: a Retrospective Case Series of Patients Undergoing Mechanical Thrombectomy
- ClinicalTrials.gov ID
- NCT04804085
- Acronym / sponsor ID
- 20AN004
- Conditions
- Stroke, Ischemic, Anesthesia
- Keywords
- Anaesthesia, Ischaemic, Mechanical, Case Series, Endovascular, Thrombectomy, Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Title: Conduct of anaesthesia during acute ischaemic stroke: a retrospective case series of patients undergoing mechanical thrombectomy.
Design: This study will be a retrospective consecutive observational case series
Detailed description
The Aim of this study is to describe the baseline characteristics, procedural and post-operative clinical characteristics of anaesthetic care delivered to consecutive adult patients who underwent mechanical thrombectomy as part of their routine clinical care between 01/01/2016 and 01/10/2020 at Nottingham University Hospitals NHS Trust (sample size approximately 250).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be identified by existing clinical records of mechanical thrombectomy procedures undertaken at Nottingham University Hospitals and already collated as part of routine service evaluation and clinical care. Sampling will be consecutive. The sampling window (01/01/2016-01/10/2020) has been chosen because mechanical thrombectomy is a new therapy that was not undertaken in current form before 2016.
Key inclusion criteria (2 listed)
- Age ≥ 18 years old
- Undergone mechanical thrombectomy for the management of acute ischaemia stroke between 01/01/2016-01/10/2020 at Nottingham University Hospitals NHS Trust.
Key exclusion criteria (1 listed)
- No pre-specified exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluating the number of patients requiring mechanical thrombectomy
Time frame: Through study completion, up to 9 months
This retrospective study will identify the anaesthetic care delivered to a group of patients undergoing mechanical thrombectomy for the management of acute ischaemic stroke. The data collected will be from all patients that received this treatment between 01/01/2016 and 01/10/2020 at Nottingham University Hospitals NHS Trust. This data written up and of interest both to our organisation and to comparable neuroscience centres in the UK and internationally. Outcomes that will be measured in this clinical case study are highlighted below.
24 secondary outcomes
Background information: Age (>/= 18 years of age)
Time frame: Through study completion, up to 9 months
Background information: Gender (male or female)
Time frame: Through study completion, up to 9 months
Background information: The degree of disability/dependence after a stroke will be measured using the presenting modified Rankin Score
Time frame: Through study completion, up to 9 months
Background information: Presenting blood pressure (systolic and diastolic)
Time frame: Through study completion, up to 9 months
Background information: Presenting heart rate (beats per minute)
Time frame: Through study completion, up to 9 months
Background information: The fitness of the patient will be measured using the American Society of Anaesthetists Classification
Time frame: Through study completion, up to 9 months
Background information: Height of the patient (m)
Time frame: Through study completion, up to 9 months
Background information: Weight of the patient (kg)
Time frame: Through study completion, up to 9 months
Background information: Measuring the distance from referring hospital (miles)
Time frame: Through study completion, up to 9 months
The patient's stroke classification will be measured using National Institute for Health Stroke Scale
Time frame: Through study completion, up to 9 months
Mode of anaesthesia
Time frame: Through study completion, up to 9 months
To identify the anaesthetic agents used
Time frame: Through study completion, up to 9 months
The level of the anaesthetist (registrar / consultant)
Time frame: Through study completion, up to 9 months
Intra - procedural observations: Measuring time spent with systolic blood pressure (mmHg) <10% of presenting BP (minutes)
Time frame: Through study completion, up to 9 months
Intra - procedural observations: Quantifying any episodes of hypoxia (SpO2 <94%)
Time frame: Through study completion, up to 9 months
Intra-procedural interventions: Identifying if the patient required vasopressors
Time frame: Through study completion, up to 9 months
Measuring the response of treatment using the post-procedural Thrombolysis in Cerebral Infarction scale
Time frame: Through study completion, up to 9 months
To identify the level of care required immediately post procedure (Level 0,1,2,3)
Time frame: Through study completion, up to 9 months
Identify the duration of Intensive Care stays (days)
Time frame: Through study completion, up to 9 months
Identify the duration of stay in hospital (days)
Time frame: Through study completion, up to 9 months
To measure the long term outcome: National Institute for Health Stroke Scale at 24 hours post-procedure
Time frame: Through study completion, up to 9 months
To measure the long term outcome: Modified Rankin Score at 90 days
Time frame: Through study completion, up to 9 months
To measure the long term outcome: Mortality at 90 days (survived / deceased)
Time frame: Through study completion, up to 9 months
To measure the long term outcome: Discharge destination (home / institution)
Time frame: Through study completion, up to 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Hewson (Consultant Anaesthetist) principal investigator
Nottingham University Hospitals NHS Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Ischemic and Anesthesia, run by Nottingham University Hospitals NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Hewson (Consultant Anaesthetist) (01159249924 ext. 61195, david.hewson@nuh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the number of patients requiring mechanical thrombectomy (time frame: Through study completion, up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.