Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001116415
Ethics application status
Approved
Date submitted
15/08/2016
Date registered
17/08/2016
Date last updated
17/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cognitive and Psychosocial Assessment After Mechanical Ventilation in Intensive Care - Does an Experience of Delirium Make a Difference?
Scientific title
Cognitive and Psychosocial Assessment After Mechanical Ventilation in Intensive Care - Does an Experience of Delirium Make a Difference: exploring cognitive and psychosocial outcomes following mechanical ventilation of patients in Intensive Care Unit (ICU) - one year follow up after ICU discharge.
Secondary ID [1] 289816 0
Nil known
Universal Trial Number (UTN)
U1111-1186-0365
Trial acronym
CAPA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium in ICU ventilated patients 299771 0
Condition category
Condition code
Mental Health 299707 299707 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 299708 299708 0 0
Anxiety
Mental Health 299727 299727 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We are following patients who were mechanically ventilated for more than 24 hours in the Intensive Care Unit. We check for the presence of Delirium during their ICU admission by administering the Confusion Assessment Method for the ICU (CAM-ICU). CAM-ICU is a validated and widely used instrument for diagnosing delirium with yes/no questions administered to non-speaking, mechanically ventilated ICU patients. Based on this assessment, we allocate patients into the delirium positive and the delirium negative group. Positive delirium is diagnosed if patients have following present: 1) Acute onset and fluctuating course of Mental State; 2) Inattention; and either 3) Altered Consciousness, or 4) Disorganised Thinking. Both delirium positive and delirium negative groups are then followed up for 12 months. .
Intervention code [1] 295524 0
Not applicable
Comparator / control treatment
We are looking at one cohort of mechanically ventilated patients. We are dividing these patients into two groups after testing for a presence of delirium. We are then comparing cognition and psychosocial outcomes of these two groups: delirium positive and delirium negative group of patients.
Control group
Active

Outcomes
Primary outcome [1] 299171 0
1. Cognitive assessment, instrument used:
-Mini Mental State Exam (MMSE)
Timepoint [1] 299171 0
At ICU discharge, and at 6 and 12 months after the ICU discharge.
Primary outcome [2] 299184 0
2. Psychosocial function, instruments used:
-Impact of Events Scale - Revised (IES-R).
-Informant Questionnaire for Cognitive Decline (IQCODE).
Timepoint [2] 299184 0
-IES-R at 6 and 12 months after the discharge from ICU.
-IQCODE at 12 months discharge from ICU.
Secondary outcome [1] 326445 0
3. Mortality
Timepoint [1] 326445 0
At ICU discharge, and at 6 and 12 months after ICU discharge.

Eligibility
Key inclusion criteria
1. Mechanical ventilation for more than 24 hours
2. Older than 18 years of age.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Suspected acute primary brain lesion
2. End stage liver failure or acute hepatic failure
3. CALD background
4. Death is deemed imminent and inevitable
5. Patient is a Nursing Home Resident
6. Apache II Score of underlying terminal illness.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
We calculated that, at a type-I error rate of 5% (alpha 0.05), we could achieve an 80% power to find the clinically significant difference of 2 points with 80% power if we included minimum of 81 patients in each group (delirious/not delirious). To allow for potential drop-outs following recruitment, we plan to enrol 200 patients.
All statistical analysis will be done using Statistical Package for the Social Sciences (SPSS) Research Engine, Version IBM SPSS Statistics (2015). We plan to employ Student’s t-test to compare mean outcomes in each group when the assumption of a normal underlying distribution can be justified, and the Mann-Whitney U-test Test to compare medians when this assumption fails. We will compare differences in proportionate outcomes using Chi-square analysis. For all of these methods, we will conclude there is a statistically significant difference between groups when the test statistic corresponds to a P-value < 0.05. Results will be presented as differences between groups +/- 95% confidence intervals. We will also consider both analysis of covariance (parametric) or Kruskal-Wallis (non-parametric) testing as appropriate and will investigate the influence of potential confounders by logistic or multiple regression techniques as appropriate.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/10/2012
Date of last participant enrolment
Anticipated
30/09/2016
Actual
Date of last data collection
Anticipated
30/09/2017
Actual
Sample size
Target
162
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment hospital [1] 6414 0
The Canberra Hospital - Garran
Recruitment hospital [2] 6415 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 13954 0
2605 - Garran
Recruitment postcode(s) [2] 13955 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 294233 0
Hospital
Name [1] 294233 0
The Canberra Hospital
Country [1] 294233 0
Australia
Primary sponsor type
Individual
Name
Daniella Bulic
Address
University of New South Wales
Faculty of Medicine
High Street
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 293069 0
Individual
Name [1] 293069 0
Associate Professor Michael Bennett
Address [1] 293069 0
Prince of Wales Clinical School
Level 1 Dickinson Building
High Street
Randwick NSW 2031
Country [1] 293069 0
Australia
Secondary sponsor category [2] 293074 0
Individual
Name [2] 293074 0
Associate Professor Frank Van Harren
Address [2] 293074 0
Intensive Care Unit
Canberra Hospital
Yamba Drive
Garran, ACT 2605
Country [2] 293074 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295654 0
ACT Government Health Directorate Human Research Ethics Committee
Ethics committee address [1] 295654 0
Building 10 Level 6
Canbera Hospital
PO Box 11
Woden ACT 2606
Ethics committee country [1] 295654 0
Australia
Date submitted for ethics approval [1] 295654 0
04/07/2012
Approval date [1] 295654 0
02/10/2012
Ethics approval number [1] 295654 0
ETH.6.12.130
Ethics committee name [2] 295655 0
Human Research Ethics Committee South Eastern Sydney Local Health District
Ethics committee address [2] 295655 0

Room G71, East Wing, Edmund Blacket Building
Prince of Wales Hospital
Cnr High & Avoca Streets
RANDWICK NSW 2031
Ethics committee country [2] 295655 0
Australia
Date submitted for ethics approval [2] 295655 0
11/01/2013
Approval date [2] 295655 0
11/12/2013
Ethics approval number [2] 295655 0
12/242 (HREC/12/POWH/460)

Summary
Brief summary
We aim to evaluate the hypothesis that an experience of delirium during mechanical ventilation in the ICU impacts negatively on patients’ cognitive and psychosocial outcomes.
This is an observational, prospective study that is conducted in two Intensive Care Units in Australia: The Canberra Hospital in the Australian Capital Territory; and the Prince of Wales Hospital in Sydney, New South Wales. The study aims to recruit 162 patients who have been mechanically ventilated for more than 24 hours, and who meet the study’s inclusion/exclusion criteria. Outcome assessments will be recorded at ICU discharge, and at six and 12 months after ICU discharge. We aim to evaluate the hypothesis that an experience of delirium during mechanical ventilation in the ICU impacts negatively on patients’ cognitive and psychosocial outcomes.
Trial website
Trial related presentations / publications




.
Public notes

Contacts
Principal investigator
Name 67922 0
Ms Daniella Bulic
Address 67922 0
Prince of Wales Clinical School
Faculty of Medicine University of New South Wales
Level 1 Dickinson Building
High Street
Randwick NSW 2031
New South Wales
Country 67922 0
Australia
Phone 67922 0
+612 9382 3880
Fax 67922 0
+612 9382 3882
Email 67922 0
[email protected]
Contact person for public queries
Name 67923 0
Ms Daniella Bulic
Address 67923 0
Prince of Wales Clinical School
Faculty of Medicine University of New South Wales
Level 1 Dickinson Building
High Street
Randwick NSW 2031
New South Wales
Country 67923 0
Australia
Phone 67923 0
+612 9382 3880
Fax 67923 0
+612 9382 3882
Email 67923 0
[email protected]
Contact person for scientific queries
Name 67924 0
Ms Daniella Bulic
Address 67924 0
Prince of Wales Clinical School
Faculty of Medicine University of New South Wales
Level 1 Dickinson Building
High Street
Randwick NSW 2031
Country 67924 0
Australia
Phone 67924 0
+612 9382 3880
Fax 67924 0
+612 9382 3882
Email 67924 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCognitive and psychosocial outcomes of mechanically ventilated intensive care patients with and without delirium.2020https://dx.doi.org/10.1186/s13613-020-00723-2
N.B. These documents automatically identified may not have been verified by the study sponsor.