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Trial registered on ANZCTR


Registration number
ACTRN12615000589583
Ethics application status
Approved
Date submitted
25/05/2015
Date registered
4/06/2015
Date last updated
24/04/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Towards an improved understanding of the effect of a speaking valve on lung volumes and communication in the critically ill tracheostomised patient
Scientific title
Assessing end-expiratory lung volumes, ventilation distribution and respiratory parameters of tracheostomised mechanically ventilated ICU patients before, during and after a speaking valve trial in-line with ventilation circuit using electrical impedance tomography.
Secondary ID [1] 286800 0
Nil
Universal Trial Number (UTN)
U1111-1170-5176
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
tracheostomised mechanically ventilated ICU patients 295177 0
Condition category
Condition code
Respiratory 295422 295422 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Tracheostomised mechanically ventilated ICU patients that are using an in-line speaking valve for at least 30min will be monitored using electrical impedance tomography and respiratory inductance plethysmography for 60min. The monitoring phase will include 15min of baseline ventilation followed by 30min of speaking valve in-line with their ventilation, and followed by 15min of back to baseline ventilation with no speaking valve.
Intervention code [1] 291962 0
Not applicable
Comparator / control treatment
There is no control group. Patients act as their own controls throughout the 60min observation period of before, during and after speaking valve use.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295159 0
end expiratory lung volume
Measured using an Electrical Impedance Tomography belt around the patient's thorax.
Timepoint [1] 295159 0
across the 60min monitoring period
Secondary outcome [1] 314898 0
ventilation distribution.
Measured using an Electrical Impedance Tomography belt around the patient's thorax
Timepoint [1] 314898 0
throughout the 60min observation period
Secondary outcome [2] 314899 0
success with health related communication.
Assessed using custom made 6 item questionnaire with answers on visual analogue scale.
Timepoint [2] 314899 0
This will be administered twice:
before commencing speaking valve use
during speaking valve use
Secondary outcome [3] 315015 0
respiratory rate
Assessed using finger probe for oxygenation monitoring
Timepoint [3] 315015 0
throughout the 60min observation period
Secondary outcome [4] 315016 0
end-tidal carbon dioxide.
Assessed using slight suction through a neonatal feeding catheter at the level of the tip of the tracheostomy cannula inside the patient's trachea.
Timepoint [4] 315016 0
throughout the 60min observation period
Secondary outcome [5] 315017 0
Positive end expiratory pressure.
Standard monitoring from patient's ventilator
Timepoint [5] 315017 0
throughout the 60min observation period
Secondary outcome [6] 315018 0
Fraction of inspired oxygen.
Standard monitoring from patient's ventilator.
Timepoint [6] 315018 0
throughout the 60min observation period
Secondary outcome [7] 315019 0
oxygen saturation
Assessed using finger probe either on finger or toe
Timepoint [7] 315019 0
throughout the 60min observation period
Secondary outcome [8] 315020 0
heart rate
Assessed using finger probe for oxygen saturation either on finger or toe
Timepoint [8] 315020 0
throughout the 60min observation period
Secondary outcome [9] 315021 0
airway pressures.
Assessed via slight suction applied through a neonatal feeding catheter taken down to the level of the tip of the tracheostomy cannula inside the patient's trachea.
Timepoint [9] 315021 0
throughout the 60min observation period

Eligibility
Key inclusion criteria
20 consecutive ICU patients using a speaking valve successfully for at least 30minutes
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with severe communication difficulties, patients not suitable for electrical impedance tomography (ventricular assist devices, open sternum, extensive thoracic dressings/drains, dependent on cardiac pacing)

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
To investigate the changes in lung volumes and flows, a mixed regression model will be used, that allows for repeated measures from the same individual. Spearman's correlation coefficient will be used to determine any correlation between end expiratory lung impedance and airway pressure change. To look at differences in RR, EtCO2, HR and SpO2 paired t-tests will be used. Any p values less than 0.05 will be considered significant.

A sample size of 20 was chosen following discussions with a statistician. As no prior similar data was available, sample size calculations relied on data obtained from several case studies conducted in our ICU.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3834 0
The Prince Charles Hospital - Chermside

Funding & Sponsors
Funding source category [1] 291343 0
Charities/Societies/Foundations
Name [1] 291343 0
The Prince Charles Hospital Foundation
Address [1] 291343 0
The Prince Charles Hospital
Rode road
Chermside, 4032 QLD
Country [1] 291343 0
Australia
Funding source category [2] 293549 0
Government body
Name [2] 293549 0
NHMRC
Address [2] 293549 0
GHD Building Level 1, 16 Marcus Clarke St, Canberra ACT 2601
Country [2] 293549 0
Australia
Primary sponsor type
Individual
Name
Anna-Liisa Sutt
Address
The Prince Charles Hospital
Rode road
Chermside, 4032 QLD
Country
Australia
Secondary sponsor category [1] 290022 0
Individual
Name [1] 290022 0
Prof John Fraser
Address [1] 290022 0
The Prince Charles Hospital
Rode road
Chermside, 4032 QLD
Country [1] 290022 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292906 0
Metro North Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 292906 0
The Prince Charles Hospital
Rode road
Chermside, 4032
Ethics committee country [1] 292906 0
Australia
Date submitted for ethics approval [1] 292906 0
Approval date [1] 292906 0
29/04/2013
Ethics approval number [1] 292906 0
HREC/13/QPCH/95

Summary
Brief summary
Critically ill tracheostomised mechanically ventilated patients are often left voiceless due to air bypassing their vocal folds. There are speaking valves that can be used in this population to restore verbal communication, however they are not widely used with ICU patients due to concerns about the required cuff deflation causing a leak in the ventilation circuit and potentially leading to derecruitment of the patients' lungs. This in turn would be deleterious towards patients weaning off mechanical ventilation. This study is looking at assessing patients' lung mechanics before, during and after the speaking valve use to guide us on respiratory physiology and advise us on future best practice.
Trial website
Trial related presentations / publications
data analysis continuing
Public notes

Contacts
Principal investigator
Name 57586 0
Miss Anna-Liisa Sutt
Address 57586 0
The Prince Charles Hospital
Rode road
Chermside, 4032 QLD
Country 57586 0
Australia
Phone 57586 0
+61 7 3139 5665
Fax 57586 0
Email 57586 0
anna-liisa.sutt@health.qld.gov.au
Contact person for public queries
Name 57587 0
Miss Anna-Liisa Sutt
Address 57587 0
The Prince Charles Hospital
Rode road
Chermside, 4032 QLD
Country 57587 0
Australia
Phone 57587 0
+61 7 3139 5665
Fax 57587 0
Email 57587 0
anna-liisa.sutt@health.qld.gov.au
Contact person for scientific queries
Name 57588 0
Miss Anna-Liisa Sutt
Address 57588 0
The Prince Charles Hospital
Rode road
Chermside, 4032 QLD
Country 57588 0
Australia
Phone 57588 0
+61 7 3139 5665
Fax 57588 0
Email 57588 0
anna-liisa.sutt@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary