Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001119189
Ethics application status
Approved
Date submitted
19/07/2019
Date registered
12/08/2019
Date last updated
12/08/2019
Date data sharing statement initially provided
12/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Ventilator Hyperinflation for intensive care patients: Influence of Pressure versus Volume controlled settings to optimise expiratory flow rate bias.
Scientific title
Ventilator Hyperinflation for intensive care patients: Influence of Pressure versus Volume controlled settings to optimise expiratory flow rate bias.
Secondary ID [1] 298786 0
Nil known
Universal Trial Number (UTN)
U1111-1237-2577
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory failure 313735 0
Condition category
Condition code
Emergency medicine 312138 312138 0 0
Other emergency care
Physical Medicine / Rehabilitation 312370 312370 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ventilator hyperinflation (VHI) is a technique used in Intensive Care Units by physiotherapists. VHI aims to assist in the removal of secretions from the lungs in patients who are intubated and receiving mechanical ventilation by adjusting the patient's mechanical ventilator settings to deliver breaths of a larger size in a slow controlled manner. While the use of VHI in Australia is increasing, different VHI protocols (i.e. ventilator setting adjustments) are utilised between hospitals.

This study will be conducted in the intensive care unit of a major tertiary hospital. A single Physiotherapist with >10 years experience will administer VHI to two groups of patients.
Group 1: Low Positive End Expiratory Pressure (PEEP) 5-9 cmH2O
Group 2: High PEEP 10-15 cmH2O

Patients will be allocated to Group 1 or 2 according to the level of PEEP they are receiving as part of their clinical management (i.e. their ventilator settings including PEEP level prescribed by the medical staff as part of the management of their clinical presentation). The effect of VHI will be analysed within these groups.

Each group will have three ventilator hyperinflation protocols applied. The protocols will vary the mode of ventilation and target pressures used.

Group 1: Low PEEP 5-9 cmH2O
VHI Protocols
1. Pressure support ventilation (PSV) with Pressure Support set so that PIP equals 35cmH2O
2. Synchronised Intermittent Mandatory Ventilation - Volume Control (SIMV-V) with maximum tidal volume to a peak inspiratory pressure (PIP) limit of 35cmH2O
3. SIMV-V with maximum tidal volume resulting in a driving pressure limit of 20cmH2O

Group 2: High PEEP 10-15 cmH2O
VHI Protocols
1. SIMV-V with maximum tidal volume resulting in a driving pressure limit of 20cmH2O
2. SIMV-V with maximum tidal volume to a PIP limit of 35cmH2O
3. BiLevel mode with High PEEP to low PEEP range equals 20cmH2O (driving pressure limit)

The order that the VHI protocols are applied within each group will be randomised.

Each protocol will be applied for 2 minutes. For each patient, when each VHI method is applied, the settings will be documented and reported to assess the fidelity to the described protocols.

After the application of a VHI protocol, the patient’s ventilator settings will be returned to their baseline settings for a period of 10 minutes, before the next VHI protocol will be performed.
Intervention code [1] 315054 0
Treatment: Other
Comparator / control treatment
Main comparator = Synchronised Intermittent Mandatory Ventilation - Volume Control (SIMV-V) with maximum tidal volume to a peak inspiratory pressure (PIP) limit of 35cmH2O

VHI protocols will be applied to two groups (low PEEP versus High PEEP). However, neither group is a control group.

Patients will act as their own control (cross-over study) with 3 VHI protocols applied.
Control group
Active

Outcomes
Primary outcome [1] 320782 0
Average peak expiratory flow rate (PEFR) for VHI breaths applied over a 2 minute period will be measured via the patient's mechanical ventilator. Breath by breath numerical values for the VHI breaths will be exported from the ventilator via a USB and analysed in Excel.
Timepoint [1] 320782 0
2 minute period post application of VHI according to target protocol .
Primary outcome [2] 320783 0
Average peak Inspiratory flow rate (PIFR) for VHI breaths applied over a 2 minute period will be measured via the patient's mechanical ventilator. Breath by breath numerical values for the VHI breaths will be exported from the ventilator via a USB and analysed in Excel.
Timepoint [2] 320783 0
2 minute period post application of VHI according to target protocol .
Secondary outcome [1] 372838 0
PIFR/PEFR. PIFR & PEFR obtained from the ventilator as outlined above will be used to determine the ratio of PIFR/PEFR using an Excel spreadsheet.
Timepoint [1] 372838 0
2 minute period post application of VHI according to target protocol .
Secondary outcome [2] 373010 0
Average Exhaled tidal volume for VHI breaths applied over a 2 minute period will be measured via the patient's mechanical ventilator. Breath by breath numerical values for the VHI breaths will be exported from the ventilator via a USB and analysed in Excel.
Timepoint [2] 373010 0
2 minute period post application of VHI according to target protocol.
Secondary outcome [3] 373011 0
Heart rate will be measured from the patient's electrocardiogram monitor to monitor safety of the intervention with cessation if HR less than 60 or greater than 130.
Timepoint [3] 373011 0
Baseline measurement just prior to application of a VHI protocol, 2 minutes post application of VHI whilst at target protocol and 2 minutes post application of VHI protocol (with ventilator settings returned to baseline).
Secondary outcome [4] 373012 0
Blood pressure will be measured from the patient's arterial blood pressure line, which provides a continuous digital reading of a patient's blood pressure level.
Timepoint [4] 373012 0
Baseline measurement just prior to application of a VHI protocol, 2 minutes post application of VHI whilst at target protocol and 2 minutes post application of VHI protocol (with ventilator settings returned to baseline).

To monitor safety of the intervention, the VHI protocols will be ceased if mean arterial blood pressure is less than 65mmHg at any time during their application.
Secondary outcome [5] 373013 0
Oxygen Saturation (SpO2) will be measured from the patient's pulse oximeter to monitor safety of the intervention with cessation if SpO2 is less than 90%.
Timepoint [5] 373013 0
Baseline measurement just prior to application of a VHI protocol, 2 minutes post application of VHI whilst at target protocol and 2 minutes post application of VHI protocol (with ventilator settings returned to baseline).
Secondary outcome [6] 373014 0
Patient to ventilator dys-synchrony will be measured from the patient's mechanical ventilation via observation of flow and pressure curves displayed on the ventilator (e.g. presence of M-waves, ventilator alarm triggers) to monitor safety of the intervention.
Timepoint [6] 373014 0
Baseline observation prior to application of a VHI protocol, 2 minutes post application of VHI whilst at target protocol and 2 minutes post application of VHI protocol (with ventilator settings returned to baseline).

Eligibility
Key inclusion criteria
Adult patients, aged > 18 years.
Intubated and ventilated
Stable on their current mechanical ventilation settings.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inspired oxygen (FiO2)greater than or equal to 0.7;
Oxygen saturation (SpO2) less than 90%;
PEEP greater than 15 cmH2O;
Peak inspiratory pressure (PIP) greater than 35 cmH2O on baseline ventilator settings;
Evidence of severe bronchospasm;
Mean arterial blood pressure (MABP) less than or equal to 65mmHg
Heart rate greater than 130
High dose vasopressors;
The primary condition does not warrant hyperinflation techniques e.g. exacerbation of Chronic Obstructive Pulmonary Disease, acute pulmonary oedema.

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)
The order in which the three VHI protocols is applied for each ventilated patient will be randomised, with randomisation generated from a random number table and using concealed allocation from an envelope once a patient is recruited.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Generated from a random number table from a textbook.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
For this pilot trial, a sample size of 24 participants per group will be utilised. This sample size is adequate to be able to detect a Cohen’s medium to high PEFR effect size of 0.7 in using 80% power and a type 1 error rate adjusted for three groups of 0.017 The calculation was based on a paired t-test.

A mixed effects model will be used to compare the 3 conditions per group for PIFR, PEFR, PIFR/PEFR

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/09/2019
Actual
Date of last participant enrolment
Anticipated
30/06/2020
Actual
Date of last data collection
Anticipated
30/06/2020
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14292 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 27286 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 303340 0
Other Collaborative groups
Name [1] 303340 0
Queensland Cardiorespiratory Physiotherapy Network
Country [1] 303340 0
Australia
Primary sponsor type
Individual
Name
Peter Thomas
Address
Department of Physiotherapy
Level 2 Ned Hanlon Building
Royal Brisbane and Women's Hospital
Herston QLD 4035
Country
Australia
Secondary sponsor category [1] 303366 0
None
Name [1] 303366 0
None
Address [1] 303366 0
None
Country [1] 303366 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303869 0
Royal Brisbane and Womens Hospital
Ethics committee address [1] 303869 0
Ethics committee country [1] 303869 0
Australia
Date submitted for ethics approval [1] 303869 0
25/03/2019
Approval date [1] 303869 0
03/07/2019
Ethics approval number [1] 303869 0
HREC/2019/QRBW/52793

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

Contacts
Principal investigator
Name 95086 0
Dr Peter Thomas
Address 95086 0
Physiotherapy Department
Level 2 Ned Hanlon Building
Royal Brisbane and Womens Hospital
Herston QLD 4029
Country 95086 0
Australia
Phone 95086 0
+61 7 3646 2577
Fax 95086 0
Email 95086 0
[email protected]
Contact person for public queries
Name 95087 0
Peter Thomas
Address 95087 0
Physiotherapy Department
Level 2 Ned Hanlon Building
Royal Brisbane and Womens Hospital
Herston QLD 4029
Country 95087 0
Australia
Phone 95087 0
+61 7 3646 2577
Fax 95087 0
Email 95087 0
[email protected]
Contact person for scientific queries
Name 95088 0
Peter Thomas
Address 95088 0
Physiotherapy Department
Level 2 Ned Hanlon Building
Royal Brisbane and Womens Hospital
Herston QLD 4029
Country 95088 0
Australia
Phone 95088 0
+61 7 3646 2577
Fax 95088 0
Email 95088 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?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Ending 5 years following main results publication;
Available to whom?
Case by case basis at the discretion of the Principal Investigator
Available for what types of analyses?
Only to achieve aims in an approved proposal.
How or where can data be obtained?
Principal Investigator: Peter Thomas, [email protected]


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.