ANZCTR - Registration

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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]

none

Universal Trial Number (UTN)

Trial acronym

SIGH-CTSU

Linked study record

Health condition

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

Mechanical ventilation

Condition category

Condition code

Respiratory

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]

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]

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]

time at which patient is extubated

Secondary outcome [1]

Adverse event associated with ventilation
e.g. pneumothorax
ventilator associated pneumonia

Assessed via data-linkage to medical records (electronic medical records)

Timepoint [1]

at time of discharge

Secondary outcome [2]

Reintubation

Assessed via data-linkage to medical records (electronic medical records)

Timepoint [2]

at time of discharge

Secondary outcome [3]

Time in ICU

Assessed via data-linkage to medical records (electronic medical records)

Timepoint [3]

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?

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)

Recruitment hospital [1]

Flinders Medical Centre - Bedford Park

Recruitment postcode(s) [1]

5042 - Bedford Park

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Southern Adelaide Local Health Network ( ICU research fund)

Address [1]

Flinders Medical Centre
Flinders Drive
Bedford Park
5042
SA

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Southern Adelaide Clinical Human Research Ethics Committee

Ethics committee address [1]

Flinders Medical Centre
Flinders Drive
Bedford Park
5042
SA

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/02/2022

Approval date [1]

Ethics approval number [1]

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

Dr Amy Chapman

Address

Flinders Medical Centre
Flinders Drive
Bedford Park
5042
SA

Country

Australia

Phone

+61 0431519465

Fax

AMY.CHAPMAN@SA.GOV.AU

Contact person for public queries

Name

Amy Chapman

Address

Flinders Medical Centre
Flinders Drive
Bedford Park
5042
SA

Country

Australia

Phone

+61 0431519465

Fax

AMY.CHAPMAN@SA.GOV.AU

Contact person for scientific queries

Name

Amy Chapman

Address

Flinders Medical Centre
Flinders Drive
Bedford Park
5042
SA

Country

Australia

Phone

+61 0431519465

Fax

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.	Type	Citation	Link	Email	Other Details	Attachment
15135	Informed consent form					383293-(Uploaded-17-02-2022-10-43-30)-Study-related document.docx

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.

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