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Trial registered on ANZCTR

Registration number

ACTRN12624000952549

Ethics application status

Approved

Date submitted

21/06/2022

Date registered

6/08/2024

Date last updated

6/08/2024

Date data sharing statement initially provided

6/08/2024

Type of registration

Retrospectively registered

Titles & IDs

Public title

Effect of Early use of in-line speaking valve on time to wean from mechanical ventilation in Intensive Care Unit patients with tracheostomies: a pilot randomised controlled trial

Scientific title

Effect of Early use of in-line speaking valve on time to wean from mechanical ventilation in Intensive Care Unit patients with tracheostomies: a pilot randomised controlled trial

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

tracheostomy

weaning mechanical ventilation

speech in ICU

Condition category

Condition code

Physical Medicine / Rehabilitation

Speech therapy

Physical Medicine / Rehabilitation

Physiotherapy

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Early use of speaking valve in patients who have received tracheostomy in intensive care units (within 72 hours of tracheostomy insertion)
1.Insertion of standard one way speaking valve into ventilator circuit (speaking valve is put into ventilator circuit for the period of the intervention)
2. Initial application will be performed by speech pathologist and physiotherapist and within 72 hours of tracheostomy. Subsequent applications may be done by suitably trained nursing staff
3. Aim will be for 30-60 minutes initially once and then twice daily up to 60 minutes the following day (may be extended longer with time recorded if tolerated well by the patient). The speaking valve is removed from ventilator circuit at the end of each trial. This will continue daily until the patient is weaned from the ventilator (at which point all patients will have access to non ventilator circuit speaking valves as is standard practice)
4. Successful application, time applied/duration will be recorded and any reason for failure

Ventilator strategies will be as per the treating clinician

Intervention code [1]

Treatment: Other

Intervention code [2]

Rehabilitation

Comparator / control treatment

Standard care
Weaning from ventilation and use of speaking valves will be as per the treating clinician. No specific guidelines or protocols will be provided

Control group

Active

Outcomes

Primary outcome [1]

Feasibility of early use of in-line speaking valve use. This will be measured by meeting all of the following:
• >50% of patients suitable for the trial are enrolled (audit of study enrolment logs)
• >50% of patients successfully have speaking valve trial
• >70% of patients in intervention arm getting speaking valve within 72hrs of enrolment

Success of the trial and timing will be prospectively recorded by the speech pathologist and nursing staff implementing the speaking valve trial on the paper case report form, which will be stored in the patient notes. This will then be transcribed to the REDCAP database by study personnel or research staff.

Timepoint [1]

For period in hospital while patient has tracheostomy in situ

Primary outcome [2]

Absence of adverse events during speaking valve trial. <25% of patients experience:
• Desaturation to <90%
• Visible aspiration that requires cessation of the speaking valve trial

This will be recorded by the speech pathologist, physiotherapist or nursing staff who are inserting the speaking valve into the ventilator circuit

Timepoint [2]

2 weeks post tracheostomy insertion or until tracheostomy is not required

Secondary outcome [1]

Length of stay (ICU) - recorded routinely for all ICU patients in national ICU database as part of mandatory requirements

Timepoint [1]

Until discharge from ICU

Secondary outcome [2]

Days post tracheostomy to a) one-way valve application - recorded by speech pathologist on case report form who applies the speaking valve

Timepoint [2]

This will be checked daily until 2 weeks or until tracheostomy removed

Secondary outcome [3]

Ease of communication scale scale -

Timepoint [3]

daily for 1 week and then twice a week for another week or until trachesotomy is removed

Secondary outcome [4]

Time to decannulation - recorded prospectively by ICU tracheostomy team who are involved in ward tracheostomy care.

Timepoint [4]

up to 28 days post tracheostomy insertion- censored at 28 days

Secondary outcome [5]

Mechanical ventilation duration post tracheostomy - currently recorded in hours as per mandatory national ICU database

Timepoint [5]

up to 28 days post tracheostomy insertion

Secondary outcome [6]

New hospital acquired pneumonia - diagnosed by treating team and receiving treatment for this - reviewed by treating team on case report form - medical records will also be checked by principal investigator

Timepoint [6]

up to 2 weeks post recruitment

Secondary outcome [7]

Hospital Length of Stay

Timepoint [7]

From admission to hospital discharge - recorded routinely as part of national ICU database

Secondary outcome [8]

Days to phonation post tracheostomy

Timepoint [8]

Recorded by speech pathologist who reviews patient daily and recorded onto case report form

Eligibility

Key inclusion criteria

Tracheostomy inserted in ICU – air filled cuffed tube
Mechanically ventilated but able to spontaneously breathe
Able to obey one stage commands within the previous 24 hrs
Tracheostomy leak demonstrated on cuff deflation to be >40% of tidal volumes
>18 years of age
Within 72 hrs of tracheostomy
Expected stay in ICU beyond next calendar day

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Deemed unsuitable for speaking valve by primary physician – reason to be recorded
Requiring heavy sedation for high intracranial pressures
PEEP required >10
FiO2 required >60%
Severe airway obstruction which may prevent sufficient exhalation
Severely reduced lung elasticity which may cause air trapping

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)

Randomised in block sizes of 6
Sealed envelopes with randomisation key within ICU

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer generation

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Descriptive statistics will be performed for baseline demographics. Independent t-tests will be used for the primary outcome.
For other outcomes - Non parametric tests where results are not normally distributed. And Chi square tests for categorical variables
A statistical plan will be finalised prior to enrolment of the first patient.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

4/04/2024

Date of last participant enrolment

Anticipated

25/12/2026

Actual

Date of last data collection

Anticipated

8/03/2027

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Sir Charles Gairdner Hospital - Nedlands

Recruitment hospital [2]

Fiona Stanley Hospital - Murdoch

Recruitment postcode(s) [1]

6009 - Nedlands

Recruitment postcode(s) [2]

6150 - Murdoch

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Sir Charles Gairdner Hospital Research Grant

Address [1]

Hospital Ave, Nedlands, Western Australia 6009

Country [1]

Australia

Primary sponsor type

Hospital

Name

Sir Charles Gairdner Hospital

Address

Hospital Ave, Nedlands, WA 6009

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sir Charles Gairdner Osborne Park Health Care Group

Ethics committee address [1]

Hospital Ave, Nedlands, WA, 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/09/2022

Approval date [1]

01/08/2023

Ethics approval number [1]

Summary

Brief summary

In patients who are unable to be safely taken off a mechanical ventilator a tracheostomy is often placed to help protect their airway gradually reduce the mechanical ventilator support.

One-way valves can be used within a ventilator circuit to direct air through the upper airway during expiration, allowing speech and communication. 

Research suggests the use of speaking valves during mechanical ventilation is safe, improves communication, may reduce time to weaning off ventilation and removal of tracheostomy.

This project aims to evaluate whether the early use of a speaking valve within the ventilator circuit in suitable patients results in earlier weaning from mechanical ventilation and earlier communication.
 
The primary outcome will be feasibility and safety with the ability to pivot to a primary outcome of duration of mechanical ventilation post tracheostomy utilising the pilot results.  Secondary outcomes include mechanical ventilation duration, ease of communication, patient and family, satisfaction and length of stay.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Bradley Wibrow

Address

C/O - Sir Charles Gairdner Hospital Intensive Care, Hospital Ave, Nedlands , WA 6009

Country

Australia

Phone

+61 422410689

Fax

[email protected]

Contact person for public queries

Name

Bradley Wibrow

Address

C/O - Sir Charles Gairdner Hospital Intensive Care, Hospital Ave, Nedlands , WA 6009

Country

Australia

Phone

+61 422410689

Fax

[email protected]

Contact person for scientific queries

Name

Bradley Wibrow

Address

C/O - Sir Charles Gairdner Hospital Intensive Care, Hospital Ave, Nedlands , WA 6009

Country

Australia

Phone

+61 422410689

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Outcome data from CRF

When will data be available (start and end dates)?

1 year-5 years after the completion date of the trial at discretion on the principle investigator

Available to whom?

Fellow researchers

Available for what types of analyses?

Individual patient analysis or meta-analysis

How or where can data be obtained?

Contact principal investigator - [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
16424	Study protocol					384246-(Uploaded-21-06-2022-03-11-58)-Study-related document.docx
16425	Statistical analysis plan				pending - to be uploaded once finalised

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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