Condition category
Mental and Behavioural Disorders
Date applied
15/12/2017
Date assigned
07/02/2018
Last edited
06/03/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Over the last ten years there has been an increase in the number of older people having major surgery for a lot of different conditions. Older people are more likely to have problems after surgery and one of the risks is getting delirium. Delirium causes confusion and can sometimes make people forgetful and paranoid. Common problems after surgery like pneumonia and heart attacks are well known but delirium is not as well understood. We know other things will make delirium more likely such as already having dementia or drinking too much alcohol but we don’t know a lot about what leads to healthy people getting delirium after surgery. People who develop delirium have a slower recovery and are at risk of developing memory and thinking problems later in life. There has been no research done specifically about how to minimise the risk of delirium for people going under anaesthetic and having surgery. The aim of this study is to look at different treatments people receive when having major surgery and what happens to them afterwards to then be able to see what types of treatment are more likely to cause delirium and inform a bigger study in the future.

Who can participate?
Patients aged 65 and older who are scheduled to undergo a major elective surgery who are able to give consent to join the study.

What does the study involve?
After surgery, participants are assessed for delirium and undergo a series of questionnaires. Presence of postoperative delirium (POD) is assessed on the first four postoperative days. Pre-existing health data, choice and dose of anaesthetic agents, use of depth of anaesthesia monitoring, regional versus general anaesthesia and post-operative analgesia as well as incidence of POD and overall severity of other post op complications are all recorded.

What are the possible benefits and risks of participating?
There is no direct benefit by taking part but results from the study will increase our knowledge in this area and could help people undergoing the same treatment in the future. There are no changes to standard treatment and no additional risk to the patient by taking part in the study.

Where is the study run from?
This study is being run by Freeman Hospital (UK) and takes place in hospitals in the UK.

When is the study starting and how long is it expected to run for?
January 2017 to June 2018

Who is funding the study?
Association of Anaesthetists of Great Britain and Ireland (UK)

Who is the main contact?
Dr Iain McCullagh
iain.mccullagh@nuth.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Iain McCullagh

ORCID ID

Contact details

Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8333 - protocol version 2, 04/07/2017.

Study information

Scientific title

Modifiable perioperative risk factors for postoperative delirium in older adults undergoing major elective non-cardiac surgery: a feasibility cohort study

Acronym

PODIUM 1

Study hypothesis

What are the specific drug related and perioperative factors: such as use of certain sedatives, choice of anaesthetic technique, use of depth of anaesthesia monitoring, general vs. regional anaesthesia and epidural or opiate based analgesia; that modify the risk of postoperative delirium and could be modified by a perioperative care bundle in a future clinical trial?

Ethics approval

North East - Newcastle & North Tyneside 2 Research Ethics Committee, 27/07/2017, ref: 17/NE/0183

Study design

Prospective feasibility cohort study (observational) aiming to recruit a total of 96 patients over the age of 65 scheduled to undergo major elective surgery.

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

See additional files

Condition

Delirium

Intervention

Pre-operatively the participants are assessed for delirium and undergo a series of questionnaires. Presence of postoperative delirium (POD) are assessed on the first four postoperative days. Pre-existing health data, choice and dose of anaesthetic agents, use of depth of anaesthesia monitoring, regional versus general anaesthesia and post-operative analgesia as well as incidence of POD and overall severity of other post op complications are all recorded.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Incidence of postoperative delirium in patients over 65 years of age following major, elective, non-cardiac surgery in the first four days postoperatively. Screening for delirium will be performed using the 4AT. Additional non study delirium assessments, such as the Confusion assessment method in the intensive care unit (CAM-ICU)25 which may be performed in critical care areas post op, will also be recorded for comparison.

Secondary outcome measures

1. Number of eligible patients, recruitment rates and retention rates throughout the study.
2. Time required for data collection, preoperative and daily postoperative delirium assessments.
3. To confirm the added value of employing the regional trainee research network (INCARNNET) to deliver the study. Specifically, what proportion of patient consent, data collection and post-operative testing is performed by anaesthesia trainees from this group, especially the success of weekend delirium assessment by trainees

Overall trial start date

01/01/2017

Overall trial end date

30/06/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients over 65 years of age scheduled to undergo major elective, non-cardiac, non neurosurgical elective surgery. Surgical severity will be decided by reference to SORT (Surgical Outcome Risk Tool) criteria.
2. Patient who lack capacity to consent will be included as long as they have a personal consultee who is willing to discuss the study and offer assent, ideally this will be a close relative

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

96

Participant exclusion criteria

1. Patients who are 64 years of age and under
2. Those who have require urgent or emergency surgery
3. Those undergoing cardiac and neurosurgery
4. Those unable to provide written informed consent
5. Those unable to understand written English if a translator is not available as part of routine care at the time of recruitment
6. Potential participants that do not have a personal consultee will not be included in the study

Recruitment start date

01/10/2017

Recruitment end date

05/03/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Freeman Hospital
NE7 7DN
United Kingdom

Trial participating centre

The Royal Victoria Infirmary
NE1 4LP
United Kingdom

Trial participating centre

Sunderland Royal Hospital
SR4 7TP
United Kingdom

Trial participating centre

Wansbeck General Hospital
NE63 9JJ
United Kingdom

Trial participating centre

James Cook University Hospital
TS4 3BW
United Kingdom

Sponsor information

Organisation

The Newcastle upon Tyne Hospitals Foundation Trust

Sponsor details

The Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Association of Anaesthetists of Great Britain and Ireland

Alternative name(s)

AAGBI

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal. See attached protocol.

IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/06/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/03/2018: 1. Recruitment end date changed from 28/02/2018 to 05/03/18 2. Overall trial end date changed from 31/03/2018 to 30/06/2018 3. Intention to publish date changed from 31/01/2019 to 30/06/2019 06/03/2018: Plain English Summary edited in line with change to overall trial end date.