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Trial registered on ANZCTR


Registration number
ACTRN12619001075178
Ethics application status
Approved
Date submitted
28/06/2019
Date registered
5/08/2019
Date last updated
5/08/2019
Date data sharing statement initially provided
5/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of intrapulmonary percussive ventilation in non-ventilated patients in intensive care on their oxygenation, lung complications and length of stay compared to standard chest physiotherapy: A randomised controlled trial
Scientific title
Effect of intrapulmonary percussive ventilation in spontaneously breathing non-ventilated patients in critical care on oxygenation, pulmonary complications and length of stay compared to standard chest physiotherapy: A randomised controlled trial
Secondary ID [1] 298625 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
pulmonary atelectasis, 313487 0
Pneumonia 313488 0
Pulmonary consolidation 313489 0
Respiratory failure 313490 0
hypoxemia 313491 0
hypoventilation 313492 0
Condition category
Condition code
Respiratory 311913 311913 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intrapulmonary percussive ventilation(IPV):
Intrapulmonary percussive ventilation is a positive pressure device which delivers mini bursts of high frequency (170 to 230 breaths per minute) sub-tidal breaths which is superimposed on patients own breathing cycle. IPV is mainly used to promote secretion clearance, reverse or prevent pulmonary atelectasis and promote oxygenation. In this study IPV will be delivered by Metaneb device (Hill-ROM, USA). Physiotherapists will be involved in delivering IPV intervention using this Metaneb device. Participants (admitted to Nepean hospital Intensive care unit) in the intervention group will receive IPV treatment for at least 10 to 30 minutes minutes twice daily. Treatment will be provided (by physiotherapist) twice daily with exception of additional treatment session(s) if there is a clinical need due to deterioration in patient condition or as requested by ICU medical team. This additional treatment session will be provided on an intention to treat basis only and reason for the additional treatment will be documented. Preferred patient position will be sitting up in a chair with feet and back supported or sitting up in bed (45 to 60 degrees head up) with hips and knees flexed 20-30 degrees, and back supported. A mouthpiece or mask interface will be used to deliver the treatment. Non-ventilated patients with tracheostomy will be connected via tracheostomy tube connector with tracheostomy and cuff will be partially deflated if tolerated by the participant. Metaneb device will deliver IPV with aerosol delivery (normal saline ~ 0.9% NaCl) via in-line nebuliser. Short rest will be given to the patients during the IPV sessions usually at every 2-3 minutes interval or as requested by the participant. Participant will be encouraged to use sputum clearance technique such as forced expiratory techniques (huffing and coughing) during the rest period or when there is a need to clear airway secretions. Parameters such as respiratory rate, heart rate and blood pressure and oxygen saturation will be continuously monitored during the treatment. This treatment will be delivered for the entire stay in ICU or when treatment will no longer required or indicated.
The criteria to stop this intervention are;
1. Nil signs of respiratory distress
2. SpO2 more than or equal to 95% on room air (more than or equal to 24 hours)
3. Resolution of consolidation/collapse (atelectasis). Assessed by the medical team (blinded)
4. Dry and non productive cough. Assessed by the medical team (blinded)

Treatment will be withdrawn in the following situation;
1. Participant refuses to continue
2. Hemodynamic instability leading to exclusion criteria
3. Acute deterioration leading to one or more exclusion criteria


Intervention code [1] 314885 0
Treatment: Devices
Comparator / control treatment
CPT group (Control)
All the eligible participants who are allocated to the control group will receive routine chest physiotherapy twice a day. Treatment will be provided twice daily by ICU physiotherapists with exception of additional treatment session(s) if there is a clinical need due to deterioration in patient condition or as requested by ICU medical team. This additional treatment session will be provided on an intention to treat basis only and reason for the additional treatment will be documented. Chest physiotherapy will consist of manual techniques such as chest percussion & vibrations, positioning, active cycle of breathing technique, forced expiratory technique and use of various positive expiratory pressure devices.

The criteria to stop this intervention are;
1. Nil signs of respiratory distress
2. SpO2 more than or equal to 95% on room air (more than or equal to 24 hours)
3. Resolution of consolidation/collapse (atelectasis). Assessed by the medical team (blinded)
4. Dry and non productive cough. Assessed by the medical team (blinded)

Treatment will be withdrawn in the following situation;
1. Participant refuses to continue
2. Hemodynamic instability leading to exclusion criteria
3. Acute deterioration leading to one or more exclusion criteria


Control group
Active

Outcomes
Primary outcome [1] 320582 0
ICU Length of stay- This will be recorded in terms of duration (days) participant stayed in ICU. This will be determined by measuring the time of ICU admission to the time when a participant is cleared for the ward by the ICU team (which is usually at the intensivist's discretion during daily morning rounds).
The above information will be obtained from the medical records.
Timepoint [1] 320582 0
This will be recorded when the participant is cleared from the ICU or when they are transferred out of ICU. This will vary for each participant.

Secondary outcome [1] 372106 0
Oxygenation: Peripheral oxygen saturation (SpO2) and fraction of inspired oxygen (FiO2) will be recorded immediately before and one hour post treatment by the bedside nurse blinded to the study objectives. The SpO2 will be recorded from the monitoring screen and FiO2 will be recorded from the oxygen delivery device or non invasive ventilator. FiO2 will be calculated where the oxygen is delivered in litres per minute by using a conversion formula (FiO2 = Litres multiply by 4 then added by 21 percent).
These two outcome are composite as one affects the other hence this outcome has been categorised under the term "oxygenation"
Timepoint [1] 372106 0
This will be measured on a daily basis immediately before, after and 1 hour post intervention by the bedside nurse blinded to the study objectives (IPV or routine chest physiotherapy) for up to 4 days

Secondary outcome [2] 372910 0
Radiological Atelectasis Score (RAS): A validated assessment tool which uses a 5-point scoring system to assess radiological changes will be used. This will be assessed using RAS by two radiologists blinded to group allocation.
Physiotherapist to request chest x-ray to be taken on the next day (day 2) post Intervention if chest x-ray is not available.

Radiological atelectasis score;
Score Description
0 Clear lung fields
1 Plate-like atelectasis or slight infiltration
2 Partial atelectasis
3 Lobar atelectasis
4 Bilateral lobar atelectasis
Timepoint [2] 372910 0
Time point: During the ICU stay
Two chest x-rays will be used for analysis (Chest x-ray taken on the same day of the intervention or day before will be compared to the one taken after the intervention or taken the next day of the intervention to allow comparison by scoring the chest x-ray. This will occur on one occasion (one pre and one post chest x-ray) only during the ICU stay.
Secondary outcome [3] 372911 0
Change in distribution of ventilation:
This outcome will be measured by using Electrical Impedance Tomography (EIT) - PulmoVista500 maufactured by Drager. EIT is a non-invasive, radiation free monitoring device which uses a chest strap (with 16 electrodes) to produce a functional image to allow direct assessment of regional lung ventilation.
Timepoint [3] 372911 0
Time point: At the time of intervention.
In this study, this device will only be used to monitor the effects of IPV intervention or CPT intervention by capturing images before, during and after the treatment sessions.

Eligibility
Key inclusion criteria
- Age: adults greater than or equal to 16 years
- FiO2 greater than or equal to 28% via mask or high flow nasal cannula or greater than or equal to 3 litres/minute via nasal cannula
- Evidence of pulmonary atelectasis or consolidation (Confirmed by ICU clinician)
- Patients with SpO2 less than or equal to 90% on room air (RA), respiratory rate (RR) greater than or equal to 25, accessory muscle use (with exception of chronic pulmonary or cardiac condition where a lower SpO2 range is acceptable by the medical team).
- Evidence of sputum retention (based on cough assessment and auscultation findings)
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intubated patients
- Hypoxemia due to non-respiratory or non-reversible causes such as congestive cardiac failure, low haemoglobin levels, pulmonary hypertension, pulmonary embolism
- Hemodynamic instability; Systolic BP less than or equal to 80 mm Hg, acute myocardial ischemia, ventricular arrhythmia
- FiO2 greater than or equal to 70%
- Pneumothorax (with or without ICC)
- Post esophagectomy / pneumonectomy patients
- Patients with facial fractures/injuries/surgeries
- Frank haemoptysis
- Uncooperative/agitated/confused patients (RASS greater than or equal to +2)
- Drowsy/sedated/unresponsive patients (RASS less than or equal to - 2)
- Pregnant women (pregnant patients in critical care are often not stable and effects of IPV in pregnant patients is unknown)
- Aggressive patients (potential harm to staff members)
- Patients with communication difficulties (NESB) - utilisation of interpreter services twice daily may not be feasible and can be expensive.

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)
Participants who meet the inclusion criteria will be randomised to the intervention or control groups using a computer- generated randomisation table (block randomisation). There will be 6 participants in each block (3 intervention and 3 control) arranged in a random fashion. The allocation sequence will be generated (by computer) by one of the research staff working in ICU, who will be completely blinded to participant’s characteristics and objectives of the study. Treatment allocation will be concealed in a sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random via computer;
The allocation sequence will be generated (by computer) by one of the research staff working in ICU, who will be completely blinded to participant’s characteristics and objectives of the study. Treatment allocation will be concealed in a sealed opaque envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Sample size calculation is based on the length of stay data from our previous unpublished pilot study where the effect size was ~1.49 days (11 vs 9.5 days). Using the generalized linear model (GLM) method, the sample size is estimated to be 82 participants (41 in each group). This calculation has considered Type I error (alpha) of 0.05, Type II error of 0.2 (Power = 0.8). Post study analysis will be done on successful completion of 82 participants. If post-study analysis fails to detect a difference with wide confidence interval, a further multicenter trial with larger sample size would be warranted.

Recruitment
Recruitment status
Not yet recruiting
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)
NSW
Recruitment hospital [1] 14123 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 26924 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 303165 0
Hospital
Name [1] 303165 0
Nepean Hospital
Address [1] 303165 0
Nepean Hospital
Derby street
Kingswood
NSW 2747
Australia
Country [1] 303165 0
Australia
Funding source category [2] 303166 0
University
Name [2] 303166 0
University of Sydney
Address [2] 303166 0
University of Sydney
Physiotherapy department - Faculty of health sciences
Cumberland campus
Lidcombe
NSW 2141
Australia
Country [2] 303166 0
Australia
Primary sponsor type
Hospital
Name
Nepean Hospital
Address
Nepean Hospital
Derby street
Kingswood
NSW 2747
Australia
Country
Australia
Secondary sponsor category [1] 303170 0
None
Name [1] 303170 0
Address [1] 303170 0
Country [1] 303170 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303727 0
Nepean blue mountains local health district human research ethics committee
Ethics committee address [1] 303727 0
Nepean Hospital
Derby street
Kingswood
NSW 2747
Australia
Ethics committee country [1] 303727 0
Australia
Date submitted for ethics approval [1] 303727 0
16/11/2018
Approval date [1] 303727 0
11/04/2019
Ethics approval number [1] 303727 0
HREC study reference: PID2018/ETH00433

Summary
Brief summary
This prospective single centre randomised, controlled, assessor-blinded study, will investigate the effects of intrapulmonary percussive ventilation (IPV) in non-ventilated patients admitted to intensive care unit (ICU) on their length of stay (LOS), oxygenation and pulmonary complications (mainly pulmonary atelectasis and consolidation) compared to standard chest physiotherapy (CPT). Patients admitted to intensive care unit, who are not ventilated, will be randomised to receive IPV treatment (intervention group) or standard CPT (control group) until discharge from physiotherapy. Outcomes in both the groups will include; number of days in ICU, changes in peripheral oxygen saturation and oxygen requirement pre and one hour post each IPV or CPT session, as well as chest x-rays scores before and after treatment. We hypothesise that participants who receive IPV intervention will have better outcomes compared to participants who receive standard chest physiotherapy.
Trial website
none
Trial related presentations / publications
none
Public notes
none

Contacts
Principal investigator
Name 94590 0
Mr Anwarul Hassan
Address 94590 0
Department of Intensive care medicine
Nepean Hospital
Derby Street
Kingswood
NSW 2747


Country 94590 0
Australia
Phone 94590 0
+61 247341166
Fax 94590 0
Email 94590 0
anwarpt77@yahoo.com.au
Contact person for public queries
Name 94591 0
Mr Anwarul Hassan
Address 94591 0
Department of Intensive care medicine
Nepean Hospital
Derby Street
Kingswood
NSW 2747


Country 94591 0
Australia
Phone 94591 0
+61 247341166
Fax 94591 0
Email 94591 0
anwarpt77@yahoo.com.au
Contact person for scientific queries
Name 94592 0
Mr Anwarul Hassan
Address 94592 0
Department of Intensive care medicine
Nepean Hospital
Derby Street
Kingswood
NSW 2747


Country 94592 0
Australia
Phone 94592 0
+61 247341166
Fax 94592 0
Email 94592 0
anwarpt77@yahoo.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The de-identified data of the participants that are published will be shared on completion of study.
When will data be available (start and end dates)?
Results will available for up to 5 years after completion of data analysis and publication.
Available to whom?
It will be decided on case by case basis
Available for what types of analyses?
meta analysis
How or where can data be obtained?
By contacting the principal investigator by email: anwarpt77@yahoo.com.au
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Clinical study report
Ethical approval
How or where can supporting documents be obtained?
Type [1] 2631 0
Study protocol
Citation [1] 2631 0
Link [1] 2631 0
Email [1] 2631 0
anwarpt77@yahoo.com.au
Other [1] 2631 0
Attachment [1] 2631 0
Type [2] 2632 0
Statistical analysis plan
Citation [2] 2632 0
Link [2] 2632 0
Email [2] 2632 0
anwarpt77@yahoo.com.au
Other [2] 2632 0
Attachment [2] 2632 0
Type [3] 2633 0
Informed consent form
Citation [3] 2633 0
Link [3] 2633 0
Email [3] 2633 0
anwarpt77@yahoo.com.au
Other [3] 2633 0
Attachment [3] 2633 0
Type [4] 2634 0
Ethical approval
Citation [4] 2634 0
Link [4] 2634 0
Email [4] 2634 0
anwarpt77@yahoo.com.au
Other [4] 2634 0
Attachment [4] 2634 0
Type [5] 2635 0
Clinical study report
Citation [5] 2635 0
Link [5] 2635 0
Email [5] 2635 0
anwarpt77@yahoo.com.au
Other [5] 2635 0
Attachment [5] 2635 0
Summary results
No Results