ANZCTR - Registration

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04840316

Registration number

NCT04840316

Ethics application status

Date submitted

7/04/2021

Date registered

12/04/2021

Titles & IDs

Public title

INcidence of PostOperative Delirium Incidence in Surgical Patients: an Observational Cohort Study in New Zealand

Scientific title

INcidence of PostOperative Delirium Incidence in Surgical Patients: an Observational Cohort Study in New Zealand

Secondary ID [1]

A+ 9133

Universal Trial Number (UTN)

Trial acronym

INPOD-NZ

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Delirium Confusional State

Complication,Postoperative

Condition category

Condition code

Neurological

Other neurological disorders

Mental Health

Other mental health disorders

Mental Health

Psychosis and personality disorders

Surgery

Other surgery

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Post operative - Nil Intervention - observational cohort study

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Incidence of postoperative delirium

Timepoint [1]

January 1st 2007 to December 31st 2016

Eligibility

Key inclusion criteria

Eligible patients include those aged 18 years or over undergoing a surgical procedure in any of 71 public or private hospitals

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Study design

Purpose

Duration

Selection

Timing

Retrospective

Statistical methods / analysis

Recruitment

Recruitment status

UNKNOWN

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

30/06/2021

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

31/12/2021

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Primary sponsor type

Government body

Name

Auckland City Hospital

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

As the population of older adults increases, so too with the number of older adult patients that present for anesthesia and surgery. The development of delirium following surgery has some significant potential effects on patient outcomes; however, POD is often under diagnosed. Some studies reported that more than 50% of patients with delirium were undiagnosed by clinical teams. POD is associated with cognitive decline, increased hospital length of stay, discharge to institutional care, mortality and higher healthcare costs. POD contributes significantly to healthcare inefficiency; a diagnosis of POD is estimated by the Australian Commission on Quality and Safety in Healthcare to cost an additional $27,791 AUD. The incidence of POD reported in clinical trials depends on the risk profile of the study population, the frequency and duration of delirium assessments as well as the surgical procedure. Reported incidence may also vary due to the presence of high-risk pathways involving multi-specialty management and intervention. POD may present as either hyperactive or hypoactive subtypes, the latter being more difficult to detect.

There are few reports on the incidence of POD in New Zealand national level datasets, with single centre studies primarily looking at in-hospital delirium and demonstrating an incidence of 11.2 to 29% on mixed and/or medical wards. A review of elderly patients with neck-of-femur fractures found the incidences of POD to be as high as 39%. The current data suggests a significant level of morbidity due to POD in New Zealand hospitals, however there is lack of national level data in the surgical population; which is crucial for establishing demographic and regional need for effective intervention.

Trial website

https://clinicaltrials.gov/study/NCT04840316

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

As an observational study of encrypted data from the national data set there is no plan to provide individual participant data.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04840316

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For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04840316