Anaesthesia for Mechanical Thrombectomy

• ClinicalTrials.gov Identifier: NCT04804085
• Recruitment Status: Not yet recruiting
• First Posted: March 18, 2021
• Last Update Posted: March 18, 2021
• Sponsor: Nottingham University Hospitals NHS Trust
• Information provided by (Responsible Party): Nottingham University Hospitals NHS Trust

Study Description

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

Condition or disease
Stroke, Ischemic; Anesthesia

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

• Study Type: Observational
• Estimated Enrollment: 250 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Conduct of Anaesthesia During Acute Ischaemia Stroke: a Retrospective Case Series of Patients Undergoing Mechanical Thrombectomy
• Estimated Study Start Date: June 1, 2021
• Estimated Primary Completion Date: August 1, 2021
• Estimated Study Completion Date: August 1, 2021

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Background information: Age (>/= 18 years of age) [ Time Frame: Through study completion, up to 9 months ]
2. Background information: Gender (male or female) [ Time Frame: Through study completion, up to 9 months ]
   Physiological gender
3. 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 ]

   0 - No symptoms.

   1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
   2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
   3. - Moderate disability. Requires some help, but able to walk unassisted.
   4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
   5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
   6. - Dead.
4. Background information: Presenting blood pressure (systolic and diastolic) [ Time Frame: Through study completion, up to 9 months ]
5. Background information: Presenting heart rate (beats per minute) [ Time Frame: Through study completion, up to 9 months ]
6. 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 ]
   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
7. Background information: Height of the patient (m) [ Time Frame: Through study completion, up to 9 months ]
   BMI = Weight / (height x height)
8. Background information: Weight of the patient (kg) [ Time Frame: Through study completion, up to 9 months ]
   BMI = Weight / (height x height)
9. Background information: Measuring the distance from referring hospital (miles) [ Time Frame: Through study completion, up to 9 months ]
   Hospitals included: Kings Mill Hospital, Royal Derby Hospital, Leicester, Lincoln, Boston, Burton
10. The patient's stroke classification will be measured using National Institute for Health Stroke Scale [ Time Frame: Through study completion, up to 9 months ]
    1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke
11. Mode of anaesthesia [ Time Frame: Through study completion, up to 9 months ]
    Awake / Sedated / Converted on-table to General Anaesthetic / GA.
12. To identify the anaesthetic agents used [ Time Frame: Through study completion, up to 9 months ]
    Propofol / Alfentanil / Remifentanil / Fentanyl / Midazolam
13. The level of the anaesthetist (registrar / consultant) [ Time Frame: Through study completion, up to 9 months ]
14. 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 ]
15. Intra - procedural observations: Quantifying any episodes of hypoxia (SpO2 <94%) [ Time Frame: Through study completion, up to 9 months ]
16. Intra-procedural interventions: Identifying if the patient required vasopressors [ Time Frame: Through study completion, up to 9 months ]
    None / metaraminol / ephedrine / noradrenaline
17. Measuring the response of treatment using the post-procedural Thrombolysis in Cerebral Infarction scale [ Time Frame: Through study completion, up to 9 months ]
    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
18. To identify the level of care required immediately post procedure (Level 0,1,2,3) [ Time Frame: Through study completion, up to 9 months ]
19. Identify the duration of Intensive Care stays (days) [ Time Frame: Through study completion, up to 9 months ]
20. Identify the duration of stay in hospital (days) [ Time Frame: Through study completion, up to 9 months ]
    Whether in NUH or otherwise
21. 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 ]
    1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke
22. To measure the long term outcome: Modified Rankin Score at 90 days [ Time Frame: Through study completion, up to 9 months ]

    0 - No symptoms.

    1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. - Moderate disability. Requires some help, but able to walk unassisted.
    4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    6. - Dead.
23. To measure the long term outcome: Mortality at 90 days (survived / deceased) [ Time Frame: Through study completion, up to 9 months ]
24. To measure the long term outcome: Discharge destination (home / institution) [ Time Frame: Through study completion, up to 9 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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.

Contacts and Locations

Contacts

Contact: David Hewson (Consultant Anaesthetist); 01159249924 ext 61195; david.hewson@nuh.nhs.uk

Contact: Heather Broll (Junior Doctor); 07717277759; heather.broll@nhs.net

Sponsors and Collaborators

Nottingham University Hospitals NHS Trust

Investigators

• Principal Investigator: David Hewson (Consultant Anaesthetist); Nottingham University Hospitals Trust

More Information

Additional Information:

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

• Responsible Party: Nottingham University Hospitals NHS Trust
• ClinicalTrials.gov Identifier: NCT04804085
• Other Study ID Numbers: 20AN004
• First Posted: March 18, 2021
• Last Update Posted: March 18, 2021
• Last Verified: March 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nottingham University Hospitals NHS Trust:

Anaesthesia; Ischaemic; Mechanical; Case Series; Endovascular; Thrombectomy; Stroke

Additional relevant MeSH terms:

Stroke; Ischemic Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases