Clinical trial NCT04804085: Anaesthesia for Mechanical Thrombectomy
Official title: Conduct of Anaesthesia During Acute Ischaemia Stroke: a Retrospective Case Series of Patients Undergoing Mechanical Thrombectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke, Ischemic
Anesthesia
Keywords: Anaesthesia
Ischaemic
Mechanical
Case Series
Endovascular
Thrombectomy
Stroke
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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

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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* No pre-specified exclusion criteria.

Primary outcomes:
measure: Evaluating the number of patients requiring mechanical thrombectomy
timeFrame: Through study completion, up to 9 months
Secondary outcomes:
measure: Background information: Age (>/= 18 years of age)
timeFrame: Through study completion, up to 9 months
measure: Background information: Gender (male or female)
timeFrame: Through study completion, up to 9 months
measure: Background information: The degree of disability/dependence after a stroke will be measured using the presenting modified Rankin Score
timeFrame: Through study completion, up to 9 months
measure: Background information: Presenting blood pressure (systolic and diastolic)
timeFrame: Through study completion, up to 9 months
measure: Background information: Presenting heart rate (beats per minute)
timeFrame: Through study completion, up to 9 months
measure: Background information: The fitness of the patient will be measured using the American Society of Anaesthetists Classification
timeFrame: Through study completion, up to 9 months
measure: Background information: Height of the patient (m)
timeFrame: Through study completion, up to 9 months
measure: Background information: Weight of the patient (kg)
timeFrame: Through study completion, up to 9 months
measure: Background information: Measuring the distance from referring hospital (miles)
timeFrame: Through study completion, up to 9 months
measure: The patient's stroke classification will be measured using National Institute for Health Stroke Scale
timeFrame: Through study completion, up to 9 months
measure: Mode of anaesthesia
timeFrame: Through study completion, up to 9 months
measure: To identify the anaesthetic agents used
timeFrame: Through study completion, up to 9 months
measure: The level of the anaesthetist (registrar / consultant)
timeFrame: Through study completion, up to 9 months
measure: Intra - procedural observations: Measuring time spent with systolic blood pressure (mmHg) <10% of presenting BP (minutes)
timeFrame: Through study completion, up to 9 months
measure: Intra - procedural observations: Quantifying any episodes of hypoxia (SpO2 <94%)
timeFrame: Through study completion, up to 9 months
measure: Intra-procedural interventions: Identifying if the patient required vasopressors
timeFrame: Through study completion, up to 9 months
measure: Measuring the response of treatment using the post-procedural Thrombolysis in Cerebral Infarction scale
timeFrame: Through study completion, up to 9 months
measure: To identify the level of care required immediately post procedure (Level 0,1,2,3)
timeFrame: Through study completion, up to 9 months
measure: Identify the duration of Intensive Care stays (days)
timeFrame: Through study completion, up to 9 months
measure: Identify the duration of stay in hospital (days)
timeFrame: Through study completion, up to 9 months
measure: To measure the long term outcome: National Institute for Health Stroke Scale at 24 hours post-procedure
timeFrame: Through study completion, up to 9 months
measure: To measure the long term outcome: Modified Rankin Score at 90 days
timeFrame: Through study completion, up to 9 months
measure: To measure the long term outcome: Mortality at 90 days (survived / deceased)
timeFrame: Through study completion, up to 9 months
measure: To measure the long term outcome: Discharge destination (home / institution)
timeFrame: Through study completion, up to 9 months
Other outcomes:
Locations:
Study officials:
affiliation: Nottingham University Hospitals Trust
name: David Hewson (Consultant Anaesthetist)
role: PRINCIPAL_INVESTIGATOR
References: