Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000949381
Ethics application status
Approved
Date submitted
26/06/2017
Date registered
3/07/2017
Date last updated
15/01/2019
Date data sharing statement initially provided
15/01/2019
Date results information initially provided
15/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Feasibility of Using Mouthpiece Ventilation Post Extubation for Acute Tetraplegia in the Intensive Care Unit.
Scientific title
The Feasibility of Using Mouthpiece Ventilation Post Extubation for Acute Tetraplegia in the Intensive Care Unit.
Secondary ID [1] 292250 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injuries 303752 0
Condition category
Condition code
Neurological 303124 303124 0 0
Other neurological disorders
Injuries and Accidents 303125 303125 0 0
Fractures
Respiratory 303126 303126 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will utilise a portable ventilator (Philips Trilogy 100) that delivers mouth piece ventilation (MPV) to support their inspiratory effort once extubated. This device provides inspiratory support via a mouthpiece or straw when participant is awake and alert and wishing to expand their lungs. The device will be set up and intervention carried out with a Senior Physiotherapist with greater than 10 years experience. All patients admitted with cervical spinal cord injury, requiring intubation and being cared for in ICU will be approached for inclusion. This feasibility study will only be conducted at Princess Alexandra Hospital, Brisbane. Participants will utilise this MPV device prophylactically from the time they are extubated through to when the participant is either discharged from ICU, requires re-intubation or dies. The participant will determine how much they utilise the MPV device to relieve any breathlessness, assist with clearing airway secretions or relieving mild fatigue. The amount of time they utilise the device will be recorded on a data memory card within the device.
Intervention code [1] 298415 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302542 0
Participant use of MPV

This will be recorded by the data memory card of the MPV device detailing the amount of time and amount of breaths the participant utilised the device. The amount of time for set-up of the device at extubation will also be noted from the memory card.
Timepoint [1] 302542 0
From extubation until participant is either discharged from ICU, requires re-intubation, dies or withdraws from the study.
Primary outcome [2] 302544 0
Participant feedback

Feedback with regard to the use, comfort and settings will be gathered from the participant on a daily basis. A semi-structured interview with regard to their use of the MPV device during their ICU stay will also be carried out.
Timepoint [2] 302544 0
Ongoing daily from extubation until participant is either discharged from ICU, requires re-intubation, dies or withdraws from the study. Once the participant is discharged from ICU they will be approached for any further feedback in a semi-structured interview with regard to their use of the MPV device during their ICU stay.
Primary outcome [3] 302613 0
Clinician feedback

Feedback from all clinicians that actively work with a patient utilising MPV as part of the study will be gathered. This will be in regard to their feedback on perceived appropriateness and positive/negative effects of MPV for the patient participant in their care. This will be carried out in a semi-structured interview.
Timepoint [3] 302613 0
Ongoing daily from extubation until patient participant is either discharged from ICU, requires re-intubation, dies or withdraws from the study.
Secondary outcome [1] 336351 0
ICU length of stay

This will be recorded as the total length of stay in intensive care for the patient participant.
Timepoint [1] 336351 0
Patient participant discharge from ICU
Secondary outcome [2] 336352 0
Sustained phonation time with/without MPV (composite outcome)

This measure is the taken as the length of time for which a participant can sustain the sound of "aaahhhh" made after taking a deep breath in and maintaining the sound at even pitch and volume. The participant will complete this with own effort breath after extubation and then when own inspiratory effort supplemented with a MPV breath.
Timepoint [2] 336352 0
This measure will be recorded daily until participant is either discharged from ICU, requires re-intubation, dies or withdraws from the study.
Secondary outcome [3] 336353 0
Incidence of pneumonia

Pneumonia is defined as new chest xray infiltrates with at least two of: temp >38 °C, shortness of breath, cough and purulent sputum, altered respiratory auscultation and white cell count >14,000/ml or leukopenia <3000/ml.
Timepoint [3] 336353 0
This measure will be recorded daily from the point of immediate pre-extubation and then daily until participant is either discharged from ICU, requires re-intubation, dies or withdraws from the study.
Secondary outcome [4] 336497 0
Forced vital capacity (FVC)

This measure will be collected using a Wright spirometer which measures lung volume through a mouthpiece or endotracheal tube connector. The highest recording will be taken after up to 5 attempts. This outcome will be collected by a Senior Physiotherapist with greater than 10 years experience.
Timepoint [4] 336497 0
This measure will be recorded daily from the point of immediate pre-extubation and then daily until participant is either discharged from ICU, requires re-intubation, dies or withdraws from the study.

Eligibility
Key inclusion criteria
All patients with newly diagnosed tetraplegia (spinal cord injury of the neck) requiring intubation and mechanical ventilation consecutively admitted to the ICU of the PAH over a 12month period will be included.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential patient participants will not be included if they are pregnant or under the age of 18

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)
Nil
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Feasibility with all new admissions meeting the inclusion criteria over 12 month period.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/07/2017
Actual
5/05/2017
Date of last participant enrolment
Anticipated
28/02/2018
Actual
30/06/2018
Date of last data collection
Anticipated
Actual
30/07/2018
Sample size
Target
12
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8447 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 16519 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 296796 0
Other Collaborative groups
Name [1] 296796 0
Hopkins Centre Interdisciplinary Seeding Grant 2017
Country [1] 296796 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
Princess Alexandra Hospital
Ipswich Rd, Woolloongabba 4102 QLD
Country
Australia
Secondary sponsor category [1] 295818 0
None
Name [1] 295818 0
Address [1] 295818 0
Country [1] 295818 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298031 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 298031 0
PAH Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 298031 0
Australia
Date submitted for ethics approval [1] 298031 0
01/11/2016
Approval date [1] 298031 0
15/11/2016
Ethics approval number [1] 298031 0
HREC/16/QPAH/688

Summary
Brief summary
Aim: To explore the feasibility of mouthpiece ventilation (MPV) use in the intensive care environment for patients who are extubated after suffering a cervical spinal cord injury and the barriers and enablers from a practice perspective.

Significance: Respiratory failure and the need for re-intubation for those suffering acute tetraplegia is a known risk which extends ICU stay and costs, delays rehabilitation and increases stress for patients and their families.
This is the first time that early application of MPV combined with standard conventional treatment in patients with cervical spinal cord injury (SCI) has been evaluated. This team will lead the way by taking the first steps towards determining if MPV can be utilised to deliver post extubation breathing support. The findings from this study will form the foundations to determining if MPV can impact on outcomes such at extubation success, need for re-intubation and ICU length of stay (LOS).

Outcomes: This study will provide much needed pilot data about a MPV intervention for catastrophic injury populations. More importantly, this study will inform of relevant factors that will likely lead to effective translation of this intervention into routine clinical practice, including the resources and education. Data from this pilot study will inform a larger study to determine the effectiveness of MPV and the health and economic benefits for individuals and the health care system. The internal and external connections established with the clinical advisory group during this study will support collaboration for a larger future trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75754 0
Mrs Brooke Wadsworth
Address 75754 0
C/O Physiotherapy Department
Princess Alexandra Hospital,
Ipswich Rd, Woolloongabba 4102 QLD
Country 75754 0
Australia
Phone 75754 0
+61731762089
Fax 75754 0
Email 75754 0
brooke.wadsworth@health.qld.gov.au
Contact person for public queries
Name 75755 0
Brooke Wadsworth
Address 75755 0
C/O Physiotherapy Department
Princess Alexandra Hospital,
Ipswich Rd, Woolloongabba 4102 QLD
Country 75755 0
Australia
Phone 75755 0
+61731762089
Fax 75755 0
Email 75755 0
brooke.wadsworth@health.qld.gov.au
Contact person for scientific queries
Name 75756 0
Brooke Wadsworth
Address 75756 0
C/O Physiotherapy Department
Princess Alexandra Hospital,
Ipswich Rd, Woolloongabba 4102 QLD
Country 75756 0
Australia
Phone 75756 0
0731762089
Fax 75756 0
Email 75756 0
brooke.wadsworth@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
Confidential. No raw data to be shared. De-identified group data only


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Fourteen people with acute spinal cord injury util... [More Details]

Documents added automatically
No additional documents have been identified.