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Trial registered on ANZCTR


Registration number
ACTRN12616001129471
Ethics application status
Approved
Date submitted
15/08/2016
Date registered
19/08/2016
Date last updated
16/06/2021
Date data sharing statement initially provided
13/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
An audit of a change in carbon dioxide level targeting in patients admitted to the intensive care unit: A before-and-after practice change audit
Scientific title
Mild Hypercapnia in Mechanically Ventilated Patients:
A Before-and-After Practice Change Audit
Secondary ID [1] 289934 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild hyercapnia during mechanical ventilation 299912 0
Condition category
Condition code
Respiratory 299811 299811 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
As a part of an evidence-based change in clinical practice, implemented from the 1st September 2016, intensive care unit clinicians will alter the mandatory respiratory rate of mechanically ventilated patients admitted to the intensive care unit to achieve a target arterial carbon dioxide level of 50-55mmHg until end of mechanical ventilation. Participant's will be followed-up from enrolment until 28 days or until death. Data associated with this practice change will be collected from September 2016 to June 2017.
Intervention code [1] 295615 0
Not applicable
Comparator / control treatment
Prior to the clinical practice change, intensive care unit clinicians altered the mandatory respiratory rate of mechanically ventilated patients admitted to the intensive care unit to achieve a target arterial carbon dioxide level of 35-45mmHg (normocapnia) until end of mechanical ventilation. Data associated with this practice change will be collected from January 2016 to August, 2016.
Control group
Historical

Outcomes
Primary outcome [1] 299284 0
Change in arterial carbon dioxide values during mechanical ventilation as measured by routine arterial blood gas assessment documented in the patient's medical record..
Timepoint [1] 299284 0
As per the routine arterial blood gas analysis data for the duration of mechanical ventilation while admitted to the intensive care unit.
Secondary outcome [1] 326726 0
Change in serum lactate values during mechanical ventilation
Timepoint [1] 326726 0
As per the routine arterial blood gas analysis data for the duration of mechanical ventilation while admitted to the intensive care unit.
Secondary outcome [2] 326727 0
Changes in serum creatinine values during mechanical ventilation.
Timepoint [2] 326727 0
As per the routine arterial blood gas analysis data for the duration of mechanical ventilation while admitted to the intensive care unit.
Secondary outcome [3] 326728 0
Incidence acquire need for renal replacement therapy (defined as that started 24 hours after admission to ICU) as documented in the patient's medical record..
Timepoint [3] 326728 0
For the duration of time the patient is admitted to the intensive care unit during the 12 month observation periods.
Secondary outcome [4] 326729 0
Change in anti-delirium medication use (Haloperidol, Olanzapine, Quetiapine and Dexmedetomidine).as documented medical history in the patient's medical record..
Timepoint [4] 326729 0
For the duration of time the patient is admitted to the intensive care unit during the 12 month observation periods.
Secondary outcome [5] 326730 0
ICU mortality
Timepoint [5] 326730 0
For the duration of time the patient is admitted to the intensive care unit during the 12 month observation periods.
Secondary outcome [6] 326731 0
Hospital mortality
Timepoint [6] 326731 0
For the duration of time the patient is admitted to the hospital during the 12 month observation periods.
Secondary outcome [7] 326732 0
ICU-free days at 28 days as determined via medical record review.
Timepoint [7] 326732 0
Medical record assessment at day 28 following enrolment.
Secondary outcome [8] 326733 0
Hospital free-days at 28 days as determined via medical record review.
Timepoint [8] 326733 0
Medical record assessment at day 28 following enrolment.

Eligibility
Key inclusion criteria
All adult mechanically ventilated patients admitted to the Department of Intensive Care, Austin Hospital will be eligible for this audit.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Receiving ECMO
2 End of life care
3 Imminent death <48 hours expected
4 Neurological injury
5 Persistent acidaemia with pH < 7.2 for > 4 hours
6 Hyperkalaemia with K > 6 for 2 hours
7 ICU admission post Cardiac Surgery
8 Right Ventricular Failure
9 Fulminant Liver Failure
10 Cerebral oedema
11 Diabetic Keto Acidosis
12 Severe Acute Hyponatraemia
13 Pulmonary hypertension
14 Transfer from another hospital

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
This is a single-centre pilot audit and the data generated from the sample will be used to determine statistically appropriate sample size of future studies.

Variables will be assessed for normality and log-transformed if appropriate. Baseline comparisons will be performed using Fisher’s exact tests and reported as n (%). Continuous normally distributed variables will be compared using Student t-tests and reported as means (standard deviation), while non-normally distributed data will be compared using Wilcoxon rank-sum tests and reported as medians [interquartile range]. Changes over time will be determined using repeated measures mixed linear modelling with each patient treated as a random effect, and therapy group, time and the interaction of therapy group and time as effect fixed effects. A two-sided p-value < 0.05 was considered evidence of a significant difference in the study outcomes.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
12/08/2016
Date of last participant enrolment
Anticipated
Actual
16/06/2021
Date of last data collection
Anticipated
30/07/2021
Actual
Sample size
Target
200
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6485 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 14048 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 294306 0
Hospital
Name [1] 294306 0
Austin Hosptial
Country [1] 294306 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road
Heidelberg
Victoria 3084
Country
Australia
Secondary sponsor category [1] 293147 0
Individual
Name [1] 293147 0
Professor Rinaldo Bellomo
Address [1] 293147 0
Director, Intensive Care Research
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country [1] 293147 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295733 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 295733 0
Ethics committee country [1] 295733 0
Australia
Date submitted for ethics approval [1] 295733 0
08/08/2016
Approval date [1] 295733 0
12/08/2016
Ethics approval number [1] 295733 0
LNR/16/Austin/346

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1032 1032 0 0
/AnzctrAttachments/371301-20160812 LNR16Austin346 (Audit) Ethics New Study Approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 68262 0
Prof Rinaldo Bellomo
Address 68262 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 68262 0
Australia
Phone 68262 0
+61 3 9496 5992
Fax 68262 0
+61 3 9496 3932
Email 68262 0
rinaldo.bellomo@austin.org.au
Contact person for public queries
Name 68263 0
Glenn Eastwood
Address 68263 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 68263 0
Australia
Phone 68263 0
+ 61 3 9496 4835
Fax 68263 0
+61 3 9496 3932
Email 68263 0
glenn.eastwood@ausitn.org.au
Contact person for scientific queries
Name 68264 0
Rinaldo Bellomo
Address 68264 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 68264 0
Australia
Phone 68264 0
+61 3 9496 5992
Fax 68264 0
+61 3 9496 3932
Email 68264 0
rinaldo.bellomo@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Pilot feasibility study in which the data will be only for hypothesis generating.


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
No additional documents have been identified.