Intraoperative hypotension in elder patients (IHypE) | Not Recruiting
Intraoperative hypotension in elder... | Not Recruiting
Intraoperative hypotension in elder patients (IHypE)
IHypE

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Medical Conditions
  • Specialty: Anaesthesia, perioperative medicine and pain management, Primary sub-specialty: Anaesthesia, Perioperative Medicine and Pain Management
  • UKCRC code/ Disease: Other/ General symptoms and signs
Primary Contact Details
Dr Alex Wickham
+44 7734 819931
See all trial contact details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN38968048
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
Background and study aims
Low blood pressure during surgery (also known as intraoperative hypotension or IOH) is thought to be very common. It happens as a side effect of the medicines used during anaesthesia (sedation during surgery). In patients aged over 65 years, this may lead to an increased risk heart attack, stroke, kidney failure and death following surgery. This risk increases as the degree and duration of low blood pressure increases. Patients aged over 65 years are at increased risk because their body is less able to cope with low blood pressure. Finding out how common IOH is can be difficult, as there is no clear and universally accepted definition. The purpose of this study is twofold. Firstly to determine how often low blood pressure occurs during operations in elderly patients in the UK and whether this is linked to a higher risk of complications. Secondly, to determine how and why anaesthetists treat low blood pressure during operations.

Who can participate?
Patients aged 65 years or older and having surgery under anaesthesia

What does the study involve?
Taking part in this study does not change the care patients would receive if they were not taking part. The researchers review the anaesthetic charts of participants undergoing surgery and record instances of IOH, as well as how serious it is and how long it lasts. Other key medical and background information is also recorded for each patient. Patients included in the study are followed up to assess their recovery up to 30 days after surgery. All information is obtained from patient records rather than face-to-face encounters. Anaesthetists, who looked after a participant, are given a questionnaire asking about individual practice in relation to the treatment of low blood pressure during surgery. The responses are collected and assessed to determine national consensus on this topic.

What are the possible benefits and risks of participating?
There are no notable benefits or risks involved with participating.

Where is the study run from?
University College Hospital and 200 of NHS hospitals (UK)

When is the study starting and how long is it expected to run for?
June 2015 to June 2017

Who is funding the study?
National Institute of Academic Anaesthesia (UK)

Who is the main contact?
Dr Alex Wickham
alex.wickham@nhs.net
Research Details
  • The aim of this study is to determine how often low blood pressure occurs during operations in elderly patients in the UK and whether this is linked to a higher risk of complications, and to investigate how and why anaesthetists treat low blood pressure during operations.
Phase
Sorry, this information is not available
Study Design
Observational; Design type: Cohort study
Study Type
Observational
Intervention

Patient Participants: No direct intervention is made as part of the study. Patient anaesthetic records are examined and data on pre-morbid health state and intraoperative blood pressure is collected. 30 day outcome data (mortality, troponin, creatinine and ischaemic stroke).

Anaesthetist participants: Anaesthetists who have anaesthetised a patient who meets the inclusion criteria will be asked to complete a short survey assessing their opinions on intraoperative hypotension in patients aged over 65 years.

Intervention Type
Other
Primary Outcome Measures
    Proportion of elderly patients developing intraoperative hypotension (IOH), the percentage drop from baseline blood pressure and the duration of hypotension. IOH will be recorded from reviewing the patients anaesthetic chart within 24 hours of having surgery. Percentage drop from baseline will be calculated using baselines of pre-induction and pre-operative blood pressure and the lowest recorded value. Duration of IOH will be calculated as the time in minutes spent consecutively at or within 5mmHg of the lowest value recorded on the anaesthetic chart.
Secondary Outcome Measures
    1. In hospital mortality at 30 days: assessed by review of the clinical record
    2. Acute kidney injury within 7 days of surgery: defined as a postoperative creatinine increase ≥1.5 times the baseline value or ≥26.5μmol/L. Assessed by review of the clinical record
    3. Myocardial injury: Defined as a postoperative troponin enzyme concentration within 7 days of surgery that is above the 99th percentile of the upper reference limit. Assessed by review of the clinical record
    4. Stroke, defined as an ischaemic stroke reported from a computed tomography (CT) scan of the brain within 7 days of surgery. Assessed by review of the clinical record
    5. Anaesthetist perceptions of and treatment thresholds for hypotension is determined by assessment of a questionnaire administered on the date of participant recruitment
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
Planned Sample Size: 1700; UK Sample Size: 300
Participant Inclusion Criteria
    1. Aged >65 years
    2. Underwent general anaesthesia or regional anaesthesia either alone or in combination in an operating theatre
    3. Emergency and elective surgery
Participant Exclusion Criteria
    1. Procedure requires cardiopulmonary bypass
    2. The patient undergoes sedation alone (that is, not in combination with regional anaesthesia)
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
London
NW1 2PG
Trial Contact(s)
Primary Trial Contact
Dr Alex Wickham
+44 7734 819931
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Intraoperative Hypotension in Elder Patients (IHypE): An Observational Study of Intraoperative Hypotension in patients aged over 65 in UK Hospitals
EudraCT Number
Sorry, this information is not available
Funder(s)
  • National Institute of Academic Anaesthesia
Other Study ID Numbers
31771
Sponsor(s)
University College London
Key Dates

Recruitment Start Date

21 Nov 2016

Recruitment End Date

31 Jan 2017

Trial Start Date

01 Jun 2015

Trial End Date

01 Jun 2017

Date added to source

02 May 2017

Date updated in source

08 Nov 2017