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Trial registered on ANZCTR


Registration number
ACTRN12622000330741p
Ethics application status
Submitted, not yet approved
Date submitted
17/02/2022
Date registered
22/02/2022
Date last updated
22/02/2022
Date data sharing statement initially provided
22/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a Sigh on ventilator weaning after Cardiothoracic surgery
Scientific title
The effect of a Sigh on ventilator weaning after Cardiothoracic surgery
Secondary ID [1] 306036 0
none
Universal Trial Number (UTN)
Trial acronym
SIGH-CTSU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mechanical ventilation 324684 0
Condition category
Condition code
Respiratory 322128 322128 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Addition of a Sigh breath in Assisted ventilation
1 Sigh every minute.
Characteristic of Sigh breath :30cmH20 over 3 secs.
Remaining breaths will be pressure-supported.

Utilisation of standard hospital ventilator available (Currently Puritan Bennet 980)

Nursing staff will setup the ventilator as per specific Ventilator setup card in order to administer the intervention . Nursing staff and Treating clinicians will be able to modify the ventilator as required (including ceasing the intervention if patient condition changes (e.g. requires mandatory mode of ventilation)

The duration of the intervention will be for the duration of mechanical ventilation in an assist mode of ventilation. If a patient is weaned and extubated, the intervention will cease. if a patient is changed to a mandatory mode of ventilation and subsequently moved back to assist mode , they will be given the intervention again if randomised to that group initially.

There will be daily checks with patient nursing staff and treating team by research team/ ICU research officer to ensure compliance and understanding. After extubation , intervention compliance will be reviewed by Research team .
Intervention code [1] 322440 0
Treatment: Devices
Comparator / control treatment
Active control (Standard practice)

As per local hospital protocol:
All elective patients undergoing Cardiac Bypass to facilitate Cardiothoracic surgery are brought to ICU post-operatively. They are intubated and weaned from mechanical ventilation not less than 4 hours after admission. As standard: patients are placed onto an assist mode of ventilation once the muscle paralysis utilised in the operation has worn off. No sigh breath is utilised.
Control group
Active

Outcomes
Primary outcome [1] 330500 0
Time on Ventilator

Data-linkage
Assessed via electronic medical records. Nursing staff document hourly when patients are mechanical ventilated, time of admission and time of extubation .
Timepoint [1] 330500 0
time at which patient is extubated
Secondary outcome [1] 406445 0
Adverse event associated with ventilation
e.g. pneumothorax
ventilator associated pneumonia

Assessed via data-linkage to medical records (electronic medical records)
Timepoint [1] 406445 0
at time of discharge
Secondary outcome [2] 406446 0
Reintubation

Assessed via data-linkage to medical records (electronic medical records)
Timepoint [2] 406446 0
at time of discharge
Secondary outcome [3] 406447 0
Time in ICU

Assessed via data-linkage to medical records (electronic medical records)
Timepoint [3] 406447 0
at time of discharge

Eligibility
Key inclusion criteria
Elective Cardiac surgery
On-pump procedure (undergoing Cardiopulmonary bypass)
Patient from Home prior to surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age < 18 years
Hx of COPD/Bulla
Pneumothorax clinically
On extracorporeal support
Not planned for extubation in next 48 hours due to other issues requiring intubation (e.g Respiratory failure, further operative plans)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Allocation concealment via opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The Protection trial published in Chest(2021) was the first RCT to examine the effects of Sigh ventilation in an ARDS population. It did not clearly stipulate ventilator weaning times for each arm.
The primary outcome is time on ventilator.
Based on current annual data collected by the FMC CTSU department, the mean ventilator times 12.4 hours. In order to see a 33% reduction of time on mechanical ventilator, we require a sample size of 150 patients with 75 patients in each arm. 160 patients chosen for safety margin.
This is Powered to 80% with an P<0.05(alpha).

Statistical analysis will be performed by a statistician. Data will be presented as n (95% CI), mean (SD) or median [IQR] as appropriate. The main analyses will be conducted on an intention to treat basis using standard statistical methods for categorical and continuous data.
Both parametric and non-parametric statistics will be used to examine the differences in the groups at baseline and their outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2022
Actual
Date of last participant enrolment
Anticipated
7/04/2023
Actual
Date of last data collection
Anticipated
21/04/2023
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 21773 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 36827 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 310373 0
Hospital
Name [1] 310373 0
Southern Adelaide Local Health Network ( ICU research fund)
Country [1] 310373 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
Flinders Medical Centre
Flinders Drive
Bedford Park
5042
SA
Country
Australia
Secondary sponsor category [1] 312052 0
None
Name [1] 312052 0
Address [1] 312052 0
Country [1] 312052 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310026 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 310026 0
Flinders Medical Centre
Flinders Drive
Bedford Park
5042
SA
Ethics committee country [1] 310026 0
Australia
Date submitted for ethics approval [1] 310026 0
10/02/2022
Approval date [1] 310026 0
Ethics approval number [1] 310026 0

Summary
Brief summary
This study will explore the impact that a sigh breath will have on ventilator weaning in post cardiac-bypass patients.

Cardiac -bypass (a form of extra-corporeal support ) is utilised to allow Cardiothoracic surgeons to operate on the heart for a variety of procedures. Due to the complexity of the case and the impact of bypass on patients, these patients remain intubated at completion of the operation. Weaning from the ventilator occurs in ICU. Patients are required to be haemodynamically stable, with minimal respiratory support before being extubated.

A sigh breath (a type of recruitment manoeuvre characterised by a high volume inspiration) has been shown to improve respiratory mechanics. It is hypothesised that patients who take a sigh breath as part of their assisted mode of ventilation will be able to be weaned off of a ventilator quicker.
This study will introduce a sigh breath to a randomised sample of elective Cardiothoracic patients in order to demonstrate improvement in the primary outcome “Time to Weaning from mechanical ventilation”. It will examine for secondary outcomes like adverse effects, re-intubation rates and other physiological parameters.
Mechanical ventilation is instituted in a variety of patients for respiratory support, to allow for certain procedures, for airway protection (e.g. in Traumatic brain injury). Mechanical ventilation is not without its dangers with longer periods of ventilation associated with increased risks. Clinicians routinely aim to extubate patients as soon as safely possible to mitigate these adverse effects. If Sigh ventilation can be shown to aid in a shorter duration of ventilation in this subset of patients , it may allow for further study into Sigh ventilation’s efficacy in other ventilated patient groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116230 0
Dr Amy Chapman
Address 116230 0
Flinders Medical Centre
Flinders Drive
Bedford Park
5042
SA
Country 116230 0
Australia
Phone 116230 0
+61 0431519465
Fax 116230 0
Email 116230 0
AMY.CHAPMAN@SA.GOV.AU
Contact person for public queries
Name 116231 0
Dr Amy Chapman
Address 116231 0
Flinders Medical Centre
Flinders Drive
Bedford Park
5042
SA
Country 116231 0
Australia
Phone 116231 0
+61 0431519465
Fax 116231 0
Email 116231 0
AMY.CHAPMAN@SA.GOV.AU
Contact person for scientific queries
Name 116232 0
Dr Amy Chapman
Address 116232 0
Flinders Medical Centre
Flinders Drive
Bedford Park
5042
SA
Country 116232 0
Australia
Phone 116232 0
+61 0431519465
Fax 116232 0
Email 116232 0
AMY.CHAPMAN@SA.GOV.AU

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
raw data of patient condition collected as required for our statistical analysis (de-indentified)
When will data be available (start and end dates)?
Start date of data analysis (date to be determined) - no end date determined
Available to whom?
Case-by-case review per SALHN guidelines
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
Principal investigator
(+61 )0431519465
Amy.chapman@sa.gov.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15135Informed consent form    383293-(Uploaded-17-02-2022-10-43-30)-Study-related document.docx



Results publications and other study-related documents

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