Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000148178
Ethics application status
Approved
Date submitted
21/08/2018
Date registered
1/02/2019
Date last updated
12/07/2022
Date data sharing statement initially provided
1/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Determining the Safety and Benefits of Exercising Patients with a Tracheostomy and a Speaking Valve
Scientific title
Determining the Safety and Benefits of Exercising Tracheostomised Mechanically Ventilated Patients with Passy-Muir Speaking Valves
Secondary ID [1] 295767 0
Nil known.
Universal Trial Number (UTN)
U1111-1218-7163
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Dysfunction 309167 0
Condition category
Condition code
Respiratory 308045 308045 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The exercise component will include five minutes of MOTOmed Letto cycling (administered and supervised by a trained intensive care physiotherapist), starting with a resistance of zero and increasing the resistance by one level each minute. The MOTOmed® Letto is a lower limb cycle ergometer that allows the lower limbs to be trained passively, motor-assisted and actively. The patient can exercise either lying in bed or sitting in a chair. The exercise will cease at five minutes or if any serious adverse events occur.
Intervention code [1] 312093 0
Rehabilitation
Comparator / control treatment
The comparator will be patients exercising without a speaking valve versus patients with the speaking valve.
Control group
Active

Outcomes
Primary outcome [1] 307165 0
End expiratory lung volumes (EELV) will be assessed using data from the PulmoVista® 500 Electrical Impedance Tomography machine. Data will be analysed offline post data collection using commercially available Draeger software (Draeger EIT Data Analysis Tool 6.1).
Timepoint [1] 307165 0
Baseline, during exercise and 30 minutes post exercise (primary endpoint).
Primary outcome [2] 307166 0
End expiratory lung impedence (EELI) will be assessed using data from the PulmoVista® 500 Electrical Impedance Tomography machine. Data will be analysed offline post data collection using commercially available Draeger software (Draeger EIT Data Analysis Tool 6.1).
Timepoint [2] 307166 0
Baseline, during exercise and 30 minutes post exercise (primary endpoint).
Primary outcome [3] 307167 0
Rib cage and abdominal mobility via abdominal-to-chest ratio (A:C) via Respiratory Inductive Plethysmography (RIP) equipment, which includes two belts, one thoracic and one abdominal.
Timepoint [3] 307167 0
Baseline, during exercise and 30 minutes post exercise (primary endpoint).
Secondary outcome [1] 350947 0
Rating of perceived exertion (RPE) via a modified Borg scale
Timepoint [1] 350947 0
Baseline.
During exercise.
30 minutes post exercise.
Secondary outcome [2] 350948 0
Distance completed as provided by the ergometer.
Timepoint [2] 350948 0
Immediately post exercise
Secondary outcome [3] 350949 0
Heart rate (HR) using electrical cardiogram.
Timepoint [3] 350949 0
Baseline.
During exercise.
30 minutes post exercise.
Secondary outcome [4] 350950 0
End tidal carbon dioxide (EtCO2) will be assessed via a FilterLine® Set CO2 Sampling Line within the ventilation circuit.
Timepoint [4] 350950 0
Baseline.
During exercise.
30 minutes post exercise.
Secondary outcome [5] 365318 0
Peripheral capillary oxygen saturation (SpO2) via pulse oximetry.
Timepoint [5] 365318 0
Baseline.
During exercise.
30 minutes post exercise.

Eligibility
Key inclusion criteria
• Adult patients admitted to ICU with a tracheostomy.
• Adult patients admitted to a hospital ward or discharged to a ward from ICU with a tracheostomy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Age under 18
• Patients unable or unwilling to provide informed consent
• Injuries to lower limbs preventing them from being able to participate in exercise therapy
• Has rest in bed orders and/or has bilateral non-weight bearing orders for the lower limbs and/or has lower limb movement restrictions preventing them from being able to do cycle ergometry
• Cardiovascular instability as determined clinically by the treating therapist or medical staff
• Proven or suspected acute primary brain pathology (e.g. traumatic brain injury, stroke, hypoxic brain injury)
• Death is deemed imminent and inevitable

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed offline post data collection using commercially available Draeger software (Draeger EIT Data Analysis Tool 6.1). EELI will be averaged across the readings and displayed as mean EELI for each of the four data collection periods. To compare two groups over time periods, a generalised linear mixed model will be used for RR, EtCO2, HR and SpO2. The level of significance will be set at p <0.05 throughout, with 95 % confidence intervals quoted where appropriate. All statistical analyses will be conducted using a data program such as STATATM.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2021
Actual
19/05/2021
Date of last participant enrolment
Anticipated
28/02/2023
Actual
Date of last data collection
Anticipated
28/02/2023
Actual
Sample size
Target
20
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11700 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 23780 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 300354 0
Hospital
Name [1] 300354 0
The Prince Charles Hospital
Country [1] 300354 0
Australia
Primary sponsor type
Hospital
Name
Physiotherapy Department - The Prince Charles Hospital
Address
Ground Floor, Main Building,
Rode Rd,
Chermside, QLD, 4032
Country
Australia
Secondary sponsor category [1] 299798 0
None
Name [1] 299798 0
Address [1] 299798 0
Country [1] 299798 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301169 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 301169 0
Building 14
Rode Road
CHERMSIDE QLD 4032
Ethics committee country [1] 301169 0
Australia
Date submitted for ethics approval [1] 301169 0
06/08/2018
Approval date [1] 301169 0
14/08/2018
Ethics approval number [1] 301169 0
HREC/18/QPCH/183

Summary
Brief summary
The focus of this study is to determine the safety and benefits of exercising patients who are mechanically ventilated via a tracheostomy whilst using a Passy-Muir speaking valve. The benefits of early exercise for patients in ICU have been well documented including: decreased ICU length of stay (LOS), hospital LOS and more ventilator-free days. Furthermore for tracheostomised patients, the benefits of utilising speaking valves (SVs) include: less accumulated secretions, decreased carbon dioxide retention, decreased respiratory rate, improved lung recruitment and greater verbal communication. Unfortunately the use of SVs has been limited due to concerns of lung derecruitment during a period of cuff deflation or conversely in some patients, hyperinflation. Fortunately recent studies have addressed these safety concerns by demonstrating that SVs did not cause derecruitment or hyperinflation of the lung, rather resulted in improved lung recruitment. It is important to note that these studies were completed with patients at rest, therefore the effect on the lungs during physiotherapy or exercise still needs to be investigated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86082 0
Mr Luke Churchill
Address 86082 0
The Prince Charles Hospital,
Physiotherapy Department,
Ground Floor, Main Building,
Rode Rd,
Chermside, QLD,
4032
Country 86082 0
Australia
Phone 86082 0
+61 7 31395310
Fax 86082 0
Email 86082 0
luke.churchill@health.qld.gov.au
Contact person for public queries
Name 86083 0
Mr Luke Churchill
Address 86083 0
The Prince Charles Hospital,
Physiotherapy Department,
Ground Floor, Main Building,
Rode Rd,
Chermside, QLD,
4032
Country 86083 0
Australia
Phone 86083 0
+61 7 31395310
Fax 86083 0
Email 86083 0
luke.churchill@health.qld.gov.au
Contact person for scientific queries
Name 86084 0
Mr Luke Churchill
Address 86084 0
The Prince Charles Hospital,
Physiotherapy Department,
Ground Floor, Main Building,
Rode Rd,
Chermside, QLD,
4032
Country 86084 0
Australia
Phone 86084 0
+61 7 31395310
Fax 86084 0
Email 86084 0
luke.churchill@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data that is collected during the project will be reidentifiable via a coding system and not of an individual nature.
Information linking named participants to these code numbers will be kept separately from any research databases and destroyed once data collection has been completed. We will ensure that all data subject to analysis and archiving is nonidentifiable in any final publications or presentations.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
921Informed consent form    375756-(Uploaded-02-01-2019-16-34-17)-Study-related document.docx
922Study protocol    375756-(Uploaded-02-01-2019-16-37-46)-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.