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Trial registered on ANZCTR


Registration number
ACTRN12610000075088
Ethics application status
Approved
Date submitted
15/01/2010
Date registered
20/01/2010
Date last updated
3/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of early versus standard Speech Pathology review and intervention: tracheostomy patients in intensive care
Scientific title
'A randomised controlled trial of tracheostomy patients in intensive care receiving early versus standard Speech Pathology intervention, does this lead to improved time to verbal communication and patient reported quality of life/satisfaction?'
Secondary ID [1] 1314 0
Nil
Universal Trial Number (UTN)
Trial acronym
ESPRIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Communication in tracheostomy patients in intensive care 256544 0
Condition category
Condition code
Physical Medicine / Rehabilitation 256716 256716 0 0
Speech therapy
Respiratory 256780 256780 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Speech Pathology intervention, tracheostomy cuff deflation on ventilation, use of speaking valve.

This is early Speech Pathology intervention which involves cuff deflation during mechanical ventilation (limit positive end expiratory pressure (PEEP) >=10) and insertion of a Passy Muir Speaking valve into the venitaltion circuit. The valve will be used for up to 1 hour day 1; 2 hours day 2; day 3 up to 4 hours and day 4 onwards up to 8 hours.
Intervention code [1] 255819 0
Treatment: Other
Comparator / control treatment
Speech Pathology intervention, tracheostomy cuff deflation off ventilation, use of speaking valve.

Standard Speech Pathology intervention involves awaiting medical team referral to assess the patient for communication/swallow, at which stage the patient has been established off the ventilator - tracheostomy cuff deflation only occurs off mechanical ventilation. The assessment involves assessment of facial muscles, deflation of tracheostomy cuff, swallow asssessment and attempts to voice.

The frequency of this treatment is delivered daily (Monday to Friday) and is delivered until complete cuff deflation is achieved and decannulation of the tracheostomy.
Control group
Active

Outcomes
Primary outcome [1] 257601 0
Time to verbal communication - this is defined as the ability to count aloud 1-10.
Timepoint [1] 257601 0
Hours from trache insertion to verbal communication
Secondary outcome [1] 262873 0
Patient safety - recording adverse events. Adverse events include death, prolongation of hospitalisation, life threatening or permanently disabiling, new onset chest infection/aspiration (defined by fever, purulent sputum and new pulmonary infiltrates). They will be assessed by the treating medical team after notification by researcher
Timepoint [1] 262873 0
Up to 1 week post tracheostomy decannulation
Secondary outcome [2] 262874 0
Time on mechanical ventilation
Timepoint [2] 262874 0
Measured from point of tracheostomy insertion until nil mechanical ventilation required, during enrolement on trial
Secondary outcome [3] 262875 0
Time with tracheostomy
Timepoint [3] 262875 0
Measured from point of tracheostomy insertion until decannulation
Secondary outcome [4] 262876 0
Length of stay in hours in Intensive Care Unit (ICU)
Timepoint [4] 262876 0
Measured from point of tracheostomy insertion until discharged from ICU
Secondary outcome [5] 262877 0
Length of stay in hospital
Timepoint [5] 262877 0
Measured from point of tracheostomy insertion until discharge from hospital
Secondary outcome [6] 262929 0
Mean quality of life/well being score - EQ-5D
Timepoint [6] 262929 0
This will be measured at day of enrolment; every 7th day enroled in study and point of discharge from study which is within 48 hours of tracheostomy decannulation
Secondary outcome [7] 262930 0
Mean satisfaction score - Visual analogue Self-Esteem Scale (VASES)
Timepoint [7] 262930 0
At baseline, daily until tracheostomy decannulation and within 48 hours of tracheostomy decannulation.

Eligibility
Key inclusion criteria
Air filled cuffed tracheostomy tube
Mechanically ventilated with Postive end expiratory pressure (PEEP) </= 10, Fraction of inspired oxygen (FiO2) </= 0.4
Tracheostomy formed for minimum 48 hours
Spontaneously triggering ventilator
Able to obey commands
Clincally stable (respiratory rate between 8-24 breaths per minute, oxygen saturation >88% of peripheral oxygen saturation(SpO2), heart rate between 40-120 beats/min and systolic blood pressure between 90-160mmHg)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contra indication to cuff deflation as per treating intensivist (eg bulbar palsy, brainstem cerebral vascular accident (CVA)
Recent Head and neck surgery

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2010
Actual
10/03/2010
Date of last participant enrolment
Anticipated
Actual
31/10/2014
Date of last data collection
Anticipated
Actual
31/10/2014
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7926 0
Royal Prince Alfred Hospital - Camperdown

Funding & Sponsors
Funding source category [1] 256312 0
Self funded/Unfunded
Name [1] 256312 0
Country [1] 256312 0
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hosptial
Address
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 251631 0
None
Name [1] 251631 0
Address [1] 251631 0
Country [1] 251631 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258393 0
Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 258393 0
Ethics committee country [1] 258393 0
Date submitted for ethics approval [1] 258393 0
27/01/2010
Approval date [1] 258393 0
02/03/2010
Ethics approval number [1] 258393 0
HREC/09/RPAH/643

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30704 0
Dr Amy Freeman-Sanderson
Address 30704 0
Speech Pathology Department
Royal Prince Alfred Hospital
Level 4
QEII Building
57-59 Missenden Road
Camperdown NSW 2050
Australia
Country 30704 0
Australia
Phone 30704 0
+61295159803
Fax 30704 0
Email 30704 0
amy.freeman-sanderson@sswahs.nsw.gov.au
Contact person for public queries
Name 13951 0
Amy Freeman-Sanderson
Address 13951 0
Speech Pathology Department
Level 4, QEII Building
57-59 Missenden Road
Camperdown NSW 2050
Country 13951 0
Australia
Phone 13951 0
+61 2 9515 9841
Fax 13951 0
Email 13951 0
amy.freeman-sanderson@sswahs.nsw.gov.au
Contact person for scientific queries
Name 4879 0
Amy Freeman-Sanderson
Address 4879 0
Speech Pathology Department
Level 4, QEII Building
57-59 Missenden Road
Camperdown NSW 2050
Country 4879 0
Australia
Phone 4879 0
+61 2 9515 9841
Fax 4879 0
Email 4879 0
amy.freeman-sanderson@sswahs.nsw.gov.au

No information has been provided regarding IPD availability


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.