Anaesthesia for Mechanical Thrombectomy

Anesthesia Clinical Trial

Official title:

Conduct of Anaesthesia During Acute Ischaemia Stroke: a Retrospective Case Series of Patients Undergoing Mechanical Thrombectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04804085
• Other study ID #: 20AN004
• Status: Not yet recruiting
• Start date: June 1, 2021
• Est. completion date: August 1, 2021

Study information

• Verified date: March 2021
• Source: Nottingham University Hospitals NHS Trust
• Contact: David Hewson (Consultant Anaesthetist)
• Phone: 01159249924
• Email: david.hewson[@]nuh.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Stroke
• Stroke, Ischemic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion, up to 9 months
Secondary	Background information: Age (>/= 18 years of age)		Through study completion, up to 9 months
Secondary	Background information: Gender (male or female)	Physiological gender	Through study completion, up to 9 months
Secondary	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.	Through study completion, up to 9 months
Secondary	Background information: Presenting blood pressure (systolic and diastolic)		Through study completion, up to 9 months
Secondary	Background information: Presenting heart rate (beats per minute)		Through study completion, up to 9 months
Secondary	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	Through study completion, up to 9 months
Secondary	Background information: Height of the patient (m)	BMI = Weight / (height x height)	Through study completion, up to 9 months
Secondary	Background information: Weight of the patient (kg)	BMI = Weight / (height x height)	Through study completion, up to 9 months
Secondary	Background information: Measuring the distance from referring hospital (miles)	Hospitals included: Kings Mill Hospital, Royal Derby Hospital, Leicester, Lincoln, Boston, Burton	Through study completion, up to 9 months
Secondary	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	Through study completion, up to 9 months
Secondary	Mode of anaesthesia	Awake / Sedated / Converted on-table to General Anaesthetic / GA.	Through study completion, up to 9 months
Secondary	To identify the anaesthetic agents used	Propofol / Alfentanil / Remifentanil / Fentanyl / Midazolam	Through study completion, up to 9 months
Secondary	The level of the anaesthetist (registrar / consultant)		Through study completion, up to 9 months
Secondary	Intra - procedural observations: Measuring time spent with systolic blood pressure (mmHg) <10% of presenting BP (minutes)		Through study completion, up to 9 months
Secondary	Intra - procedural observations: Quantifying any episodes of hypoxia (SpO2 <94%)		Through study completion, up to 9 months
Secondary	Intra-procedural interventions: Identifying if the patient required vasopressors	None / metaraminol / ephedrine / noradrenaline	Through study completion, up to 9 months
Secondary	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	Through study completion, up to 9 months
Secondary	To identify the level of care required immediately post procedure (Level 0,1,2,3)		Through study completion, up to 9 months
Secondary	Identify the duration of Intensive Care stays (days)		Through study completion, up to 9 months
Secondary	Identify the duration of stay in hospital (days)	Whether in NUH or otherwise	Through study completion, up to 9 months
Secondary	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	Through study completion, up to 9 months
Secondary	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.	Through study completion, up to 9 months
Secondary	To measure the long term outcome: Mortality at 90 days (survived / deceased)		Through study completion, up to 9 months
Secondary	To measure the long term outcome: Discharge destination (home / institution)		Through study completion, up to 9 months

External Links

•   Raising the Standards: RCoA quality improvement compendium, 4th Edition September 2020: 12.7 Endovascular thrombectomy