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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04840316
Other study ID # A+ 9133
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 30, 2021
Est. completion date December 31, 2021

Study information

Verified date May 2021
Source Auckland City Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Eligible patients include those aged 18 years or over undergoing a surgical procedure in any of 71 public or private hospitals

Study Design


Locations

Country Name City State
New Zealand Auckland City Hopsital Auckland

Sponsors (1)

Lead Sponsor Collaborator
Auckland City Hospital

Country where clinical trial is conducted

New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of postoperative delirium Clinical outcomes are coded by trained clinical coders at each individual hospital and reported to the Ministry of Health as per standard practice. Delirium will be defined by the ICD-9 and ICD-10 coding of delirium as an outcome [12]. POD will be defined as the presence of an ICD-9 or ICD-10 delirium code following surgery until seven days postoperatively or discharge, whichever occurs earlier. If a patient received multiple eligible operations during the captured time frame, each surgical event postoperatively will be analysed individually. January 1st 2007 to December 31st 2016
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