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Trial registered on ANZCTR


Registration number
ACTRN12619000783123
Ethics application status
Approved
Date submitted
16/05/2019
Date registered
27/05/2019
Date last updated
27/05/2019
Date data sharing statement initially provided
27/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effectiveness of chest physiotherapy treatment using lung ultrasound in an intensive care population
Scientific title
Diagnostic lung ultrasound in critical care: lung aeration changes associated with chest physiotherapy treatment
Secondary ID [1] 296372 0
None
Universal Trial Number (UTN)
Trial acronym
DUCHESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute lobar atelectasis 310111 0
Condition category
Condition code
Respiratory 308862 308862 0 0
Other respiratory disorders / diseases
Physical Medicine / Rehabilitation 311408 311408 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lung ultrasound examinations, as an adjunct to standard clinical assessment, will be performed on mechanically ventilated patient’s pre and post standard care chest physiotherapy treatment during a single clinical physiotherapy session in the ICU stay.
LU will be conducted by the research physiotherapist, Louise Hansell. The patient will be imaged in the semi-recumbent, 30-45 degree head-up, position. Lung ultrasound will be used to determine aeration patterns prior to delivery of physiotherapy treatment, and again following treatment, with a lung ultrasound score and lung reaeration score assigned to demonstrate the amount of focal and global aeration change. It is estimated that each lung ultrasound will take between 15-30 minutes. Lung auscultation and chest radiographs obtained from conventional respiratory bedside assessment as well as physiological measures (including arterial blood gas data, peripheral oxygen saturations, respiratory rate, tidal volume, pressure support and positive end expiratory pressure values as appropriate, PaO2/FiO2 ratio and static lung compliance (tidal volume on driving pressure) if in mandatory ventilation mode) will also be used to determine aeration change. Standard care chest physiotherapy for ventilated patients will vary between patients depending on the location of atelectasis and the clinical decision made by the clinical physiotherapist. Treatment typically comprises of positioning, mobilisation, manual/ventilator hyperinflation, Percussions/vibrations/shakes, suctioning or augmented cough, or a combination of any of these techniques.

For all patients who have undergone LU, results of thoracic CT scans performed for clinical purposes (if available) within 12hrs of having LU will also be collected. Presence or absence of acute lobar atelectasis on LU, chest radiograph and CT will be recorded.

Intervention code [1] 312706 0
Diagnosis / Prognosis
Comparator / control treatment
Patients will have undergone chest radiograph for inclusion in this study. If a patient with diagnosed atelectasis on LU also undergoes a thoracic CT scan for clinical purposes (unrelated to the study within 12hrs of having a LU), the CT results will be recorded. This will allow for diagnostic accuracy data to be collected, comparing diagnostic accuracy of LU compared with chest radiograph in diagnosing atelectasis, using thoracic CT as the reference standard.
Control group
Active

Outcomes
Primary outcome [1] 320091 0
The primary composite outcome measures of this study are the lung ultrasound score and the lung reaeration score.
Timepoint [1] 320091 0
Measures will be taken at the time of a patient receiving their first chest physiotherapy treatment, immediately prior to and immediately following this chest physiotherapy treatment. This time point at which patient's receive physiotherapy treatment will vary between patients, but we expect this will occur within 48hrs of commencing mechanical ventilation.
Secondary outcome [1] 370506 0
Lung auscultation will be recorded by the clinical physiotherapist
Timepoint [1] 370506 0
Auscultation will be conducted immediately prior to and immediately following chest physiotherapy treatment as part of standard physiotherapy bedside assessment
Secondary outcome [2] 370507 0
Length of time taken to perform bedside assessment for the clinical physiotherapist
Timepoint [2] 370507 0
Time taken to perform bedside assessment will be recorded by the clinical physiotherapist pre and post delivery of chest physiotherapy treatment
Secondary outcome [3] 370508 0
Agreement between assigning lung ultrasound scores between two physiotherapy clinicians
Timepoint [3] 370508 0
Lung ultrasound scores will be assigned by the research physiotherapist at the bedside pre and post delivery of chest physiotherapy treatment. A second physiotherapist will assign lung ultrasound scores retrospectively for each patient
Secondary outcome [4] 370509 0
Diagnostic accuracy of LU in detecting acute lobar atelectais compared to chest radiograph using thoracic computed tomography as the reference standard
Timepoint [4] 370509 0
This will be retrospectively analaysed. Chest radiographs will be taken for clinical purposes on the same day as LU
Secondary outcome [5] 370625 0
Chest radiograph findings as reported by a radiologist will be recorded by the clinical physiotherapist
Timepoint [5] 370625 0
Chest radiographs will be taken on the same day as LU is conducted. We expect chest radiographs and LU scans will be performed within 6 hours of each other
Secondary outcome [6] 370626 0
Physiological measures (including arterial blood gas data, peripheral oxygen saturations, respiratory rate, tidal volume, pressure support and positive end expiratory pressure values as appropriate, PaO2/FiO2 ratio and static lung compliance (tidal volume on driving pressure) if in mandatory ventilation mode) will be recorded,
Timepoint [6] 370626 0
Physiological measures will be recorded by the research physiotherapist immediately prior to and immediately following delivery of chest physiotherapy treatment
Secondary outcome [7] 370627 0
Length of time taken to perform bedside assessment for the research physiotherapist
Timepoint [7] 370627 0
Time taken to perform bedside LU assessment will be recorded by the research physiotherapist pre and post delivery of chest physiotherapy treatment

Eligibility
Key inclusion criteria
- Patients over 18 years of age
- Hospitalised in intensive care
- Mechanical ventilation expected for greater than 24 hours
- Suspicion of acute lobar atelectasis identified by the treating intensive care team
- Arterial line in place
- No previous chest physiotherapy treatment for their current episode of acute lobar atelectasis
- Chest x-ray (CXR) available within 12 hours of physiotherapy assessment
- Willingness of next of kin to give written consent and comply with the study
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Presence of a contraindication to chest physiotherapy
- Absence of a chest x-ray or a chest x-ray taken greater than 12 hours from the time of physiotherapy assessment
- Physiotherapist qualified in LU not available
- LU not possible (subcutaneous emphysema dressings, drains, oedema etc.)
- Body habitus preventing optimal imaging, BMI >40
- Refusal from the patient’s next of kin to participate in the study
- Withdrawal/limitations of medical care with impending death

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Single group
Other design features
Blinding:
- The research physiotherapist conducting the LU scans will not be aware of the exact treatment delivered by the clinical physiotherapist at the time of performing LU scans
- The clinical physiotherapists delivering chest physiotherapy treatment will be told if atelectasis is identified on LU scan, however will not be told location or extent of atelectasis. It will be up to their clinical assessment/judgement to identify the location (ie lobe) and the extent of the atelectasis (ie isolated lobe vs multi-lobar)
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
The comparison of pre and post standardised physiotherapy treatment lung ultrasound and lung aeration scores to quantify changes in lung aeration will be analysed. Multiple correlation coefficient will be used to determine the association between the lung ultrasound score, lung reaeration score, chest radiograph, lung auscultation and physiological measures (including arterial blood gas data, peripheral oxygen saturations, respiratory rate, tidal volume, pressure support and positive end expiratory pressure values as appropriate, and PaO2/FiO2 ratio).

The kappa coefficient will be used to determine inter-rater reliability in assigning a lung ultrasound score and reaeration score between the research physiotherapist and a LU expert.

Chi-square will be used to compare diagnostic ability of lung ultrasound and chest radiograph with thoracic computed tomography as the reference standard in diagnosing acute lobar atelectasis. Sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, receiver operating characteristic curve, diagnostic odds ratio and diagnostic accuracy will be expressed.

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] 13763 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 26512 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 300976 0
Government body
Name [1] 300976 0
NSLHD Allied Health Kickstarter Grant
Address [1] 300976 0
Royal North Shore Hospital
St Leonards NSW 2065
Country [1] 300976 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
75 East Street
Lidcombe NSW 2141
Country
Australia
Secondary sponsor category [1] 302750 0
None
Name [1] 302750 0
Address [1] 302750 0
Country [1] 302750 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301738 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 301738 0
Level 13, Research Office
Kolling Building, Royal North Shore Hospital
Pacific Highway, St Leonards NSW 2065
Ethics committee country [1] 301738 0
Australia
Date submitted for ethics approval [1] 301738 0
20/02/2019
Approval date [1] 301738 0
11/04/2019
Ethics approval number [1] 301738 0
2019/ETH00320

Summary
Brief summary
Diagnostic lung ultrasound will be used to diagnose acute lobar atelectasis in a mechanically ventilated population in intensive care. Lung ultrasound scans will also allow the research physiotherapist to assign aeration scores pre and post delivery of chest physiotherapy treatment. We hypothesise that lung ultrasound will be able to detect changes in lung aeration associated with a single chest physiotherapy treatment.
This single centre prospective cohort trial of 43 mechanically ventilated patients will be conducted in intensive care at Royal North Shore Hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87946 0
Ms Louise Hansell
Address 87946 0
Faculty of Health Sciences
The University of Sydney
75 East Street
Lidcombe NSW 2141
Country 87946 0
Australia
Phone 87946 0
+61432882934
Fax 87946 0
Email 87946 0
lste5431@uni.sydney.edu.au
Contact person for public queries
Name 87947 0
Ms Louise Hansell
Address 87947 0
Faculty of Health Sciences
The University of Sydney
75 East Street
Lidcombe NSW 2141
Country 87947 0
Australia
Phone 87947 0
+61432882934
Fax 87947 0
Email 87947 0
lste5431@uni.sydney.edu.au
Contact person for scientific queries
Name 87948 0
Ms Louise Hansell
Address 87948 0
Faculty of Health Sciences
The University of Sydney
75 East Street
Lidcombe NSW 2141
Country 87948 0
Australia
Phone 87948 0
+61432882934
Fax 87948 0
Email 87948 0
lste5431@uni.sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results