Post-Operative Delirium Investigation in the United KingdoM (PODIUM 1)

Not Applicable

Completed

• Conditions: Delirium; Mental and Behavioural Disorders

• Registration Number: ISRCTN94663125
• Lead Sponsor: The Newcastle upon Tyne Hospitals Foundation Trust

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37454100/ (added 17/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-07
• Study Completion: 2018-06-30
• Last Update Posted: 2 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 96

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
<br> 1. Number of eligible patients, recruitment rates and retention rates throughout the study.<br> 2. Time required for data collection, preoperative and daily postoperative delirium assessments.<br> 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<br>