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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] 307397 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
tracheostomy 326726 0
weaning mechanical ventilation 326727 0
speech in ICU 326728 0
Condition category
Condition code
Physical Medicine / Rehabilitation 323961 323961 0 0
Speech therapy
Physical Medicine / Rehabilitation 323962 323962 0 0
Physiotherapy
Respiratory 323963 323963 0 0
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] 323832 0
Treatment: Other
Intervention code [2] 323833 0
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] 331758 0
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] 331758 0
For period in hospital while patient has tracheostomy in situ
Primary outcome [2] 331784 0
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] 331784 0
2 weeks post tracheostomy insertion or until tracheostomy is not required
Secondary outcome [1] 411040 0
Length of stay (ICU) - recorded routinely for all ICU patients in national ICU database as part of mandatory requirements
Timepoint [1] 411040 0
Until discharge from ICU
Secondary outcome [2] 411111 0
Days post tracheostomy to a) one-way valve application - recorded by speech pathologist on case report form who applies the speaking valve
Timepoint [2] 411111 0
This will be checked daily until 2 weeks or until tracheostomy removed
Secondary outcome [3] 411112 0
Ease of communication scale scale -
Timepoint [3] 411112 0
daily for 1 week and then twice a week for another week or until trachesotomy is removed
Secondary outcome [4] 411113 0
Time to decannulation - recorded prospectively by ICU tracheostomy team who are involved in ward tracheostomy care.
Timepoint [4] 411113 0
up to 28 days post tracheostomy insertion- censored at 28 days
Secondary outcome [5] 411114 0
Mechanical ventilation duration post tracheostomy - currently recorded in hours as per mandatory national ICU database
Timepoint [5] 411114 0
up to 28 days post tracheostomy insertion
Secondary outcome [6] 411115 0
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] 411115 0
up to 2 weeks post recruitment
Secondary outcome [7] 413744 0
Hospital Length of Stay
Timepoint [7] 413744 0
From admission to hospital discharge - recorded routinely as part of national ICU database
Secondary outcome [8] 413745 0
Days to phonation post tracheostomy
Timepoint [8] 413745 0
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?
No
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
40
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 22596 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 22597 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 37851 0
6009 - Nedlands
Recruitment postcode(s) [2] 37852 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 311673 0
Hospital
Name [1] 311673 0
Sir Charles Gairdner Hospital Research Grant
Country [1] 311673 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Ave, Nedlands, WA 6009
Country
Australia
Secondary sponsor category [1] 313127 0
None
Name [1] 313127 0
Address [1] 313127 0
Country [1] 313127 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311129 0
Sir Charles Gairdner Osborne Park Health Care Group
Ethics committee address [1] 311129 0
Hospital Ave, Nedlands, WA, 6009
Ethics committee country [1] 311129 0
Australia
Date submitted for ethics approval [1] 311129 0
29/09/2022
Approval date [1] 311129 0
01/08/2023
Ethics approval number [1] 311129 0

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 120042 0
Dr Bradley Wibrow
Address 120042 0
C/O - Sir Charles Gairdner Hospital Intensive Care, Hospital Ave, Nedlands , WA 6009
Country 120042 0
Australia
Phone 120042 0
+61 422410689
Fax 120042 0
Email 120042 0
[email protected]
Contact person for public queries
Name 120043 0
Bradley Wibrow
Address 120043 0
C/O - Sir Charles Gairdner Hospital Intensive Care, Hospital Ave, Nedlands , WA 6009
Country 120043 0
Australia
Phone 120043 0
+61 422410689
Fax 120043 0
Email 120043 0
[email protected]
Contact person for scientific queries
Name 120044 0
Bradley Wibrow
Address 120044 0
C/O - Sir Charles Gairdner Hospital Intensive Care, Hospital Ave, Nedlands , WA 6009
Country 120044 0
Australia
Phone 120044 0
+61 422410689
Fax 120044 0
Email 120044 0
[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.TypeCitationLinkEmailOther DetailsAttachment
16424Study protocol    384246-(Uploaded-21-06-2022-03-11-58)-Study-related document.docx
16425Statistical 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.