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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12625001092482
Ethics application status
Approved
Date submitted
12/09/2025
Date registered
8/10/2025
Date last updated
8/10/2025
Date data sharing statement initially provided
8/10/2025
Type of registration
Retrospectively registered
Titles & IDs
Public title
Can lung ultrasound predict lung complications after open-heart surgery?
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Scientific title
Can lung ultrasound predict post-operative pulmonary complications in high-risk post-operative cardiac surgery patients?
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Secondary ID [1]
315364
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
This study is a sub-study within the primary study "Nasal Oxygen Therapy After Cardiac Surgery (NOTACS)", registration record: NCT05308719.
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Health condition
Health condition(s) or problem(s) studied:
Open-heart surgery
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Postoperative pulmonary complications
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Cardiopulmonary bypass
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Condition category
Condition code
Respiratory
335140
335140
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0
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Other respiratory disorders / diseases
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Cardiovascular
335229
335229
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Recruited participants will have all undergone open-heart surgery and be recruited to the Nasal High-flow Oxygen Therapy After Cardiac Surgery (NOTACS) international multicentre trial (registration record: NCT05308719) whereby high-risk patients undergoing open-heart surgery are allocated to either conventional/standard oxygen therapy, or nasal high-flow oxygen therapy.
Two lung ultrasound scans will be completed postoperatively at two separate timepoints: 1. Pre-extubation (within four to 12 hours pre-extubation) and 2. Post-extubation )within 12-16 hours post-extubation).
The observation period for the primary outcome (postoperative pulmonary complications (PPCs)) will be seven days postoperatively.
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Intervention code [1]
331969
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Early Detection / Screening
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Comparator / control treatment
No control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Occurrence of postoperative pulmonary complication (PPC) atelectasis.
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Assessment method [1]
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Assessed via electronic medical records for the following: Detection via computed tomography or chest radiograph within 7 days.
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Timepoint [1]
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Assessed daily within 7 days postoperatively.
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Primary outcome [2]
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Severity of PPCs
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Assessment method [2]
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Assessed via electronic medical records for the following: 1. None – planned use of supplemental oxygen or mechanical respiratory support as part of routine care, but not in response to a complication or deteriorating physiology 2. Mild – Therapeutic supplemental oxygen less than 0.6 FiO2 3. Moderate – Therapeutic supplemental oxygen equal to 0.6 FiO2 4. Severe – Unplanned (in response to a complication or deteriorating physiology) non-invasive mechanical ventilation, CPAP, or invasive mechanical ventilation requiring tracheal intubation
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Timepoint [2]
342836
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Assessed at the end of 7 days postoperatively via data collected during the NOTACS trial from electronic medical records. Data initially captured in paper case reporting forms and then transferred into a password protected electronic database. Relevance case reporting forms include Oxygen Logs and Adverse Events Logs.
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Primary outcome [3]
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Occurrence of postoperative pulmonary complication (PPC) pneumonia.
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Assessment method [3]
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Assessed via electronic medical records for the following: Detection and determination by the United States Centres for Disease Control Criteria: Two or more serial chest radiographs with at least one of the following (one radiograph is sufficient for patients with no underlying pulmonary or cardiac disease): • New or progressive and persistent infiltrates, (ii) consolidation, (iii) cavitation; AND at least one of the following: o fever (greater than 38 degrees Celsius) with no other recognised cause, o leucopaenia (white cell count 12×109 litre-1), o for adults greater than 70 yr old, altered mental status with no other recognised cause; AND at least two of the following: • new onset of purulent sputum or change in character of sputum, or increased respiratory secretions, or increased suctioning requirements, • new onset or worsening cough, or dyspnoea, or tachypnoea, • rales or bronchial breath sounds, • worsening gas exchange (hypoxaemia, increased oxygen requirement, increased ventilator demand).
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Timepoint [3]
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Assessed daily within 7 days postoperatively.
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Secondary outcome [1]
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Pre-extubation lung aeration score.
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Assessment method [1]
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Lung ultrasound aeration score (0-36) calculated retrospectively from lung ultrasound scan videos.
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Timepoint [1]
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Assessed once within four to 12 hours pre-extubation.
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Secondary outcome [2]
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Post-extubation lung aeration score.
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Assessment method [2]
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Lung ultrasound aeration score (0-36) calculated retrospectively from lung ultrasound scan videos.
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Timepoint [2]
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Assessed once within 12-16 hours post-extubation.
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Secondary outcome [3]
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Severity of PPCs (mild, moderate, severe).
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Assessment method [3]
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1. None – planned use of supplemental oxygen or mechanical respiratory support as part of routine care, but not in response to a complication or deteriorating physiology 2. Mild – Therapeutic supplemental oxygen less than 0.6 FiO2 3. Moderate – Therapeutic supplemental oxygen equal to 0.6 FiO2 4. Severe – Unplanned (in response to a complication or deteriorating physiology) non-invasive mechanical ventilation, CPAP, or invasive mechanical ventilation requiring tracheal intubation Data collected during the NOTACS trial from electronic medical records. Data initially captured in paper case reporting forms and then transferred into a password protected electronic database. Relevance case reporting forms include Oxygen Logs and Adverse Events Logs.
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Timepoint [3]
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Assessed at the end of 7 days postoperatively via data collected during the NOTACS trial from electronic patient medical records. Data initially captured in paper case reporting forms and then transferred into a password protected electronic database. Relevance case reporting forms include Oxygen Logs and Adverse Events Logs.
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Secondary outcome [4]
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Occurrence of reintubation and mechanical ventilation, assessed as a composite outcome.
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Assessment method [4]
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Assessed via electronic medical records as a composite outcome.
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Timepoint [4]
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Assessed daily within 7 days post-operatively.
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Secondary outcome [5]
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Requirement for non-invasive ventilation.
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Assessment method [5]
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Assessed via electronic medical records for presence of the outcome.
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Timepoint [5]
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Assessed daily within 7 days post-operatively.
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Secondary outcome [6]
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Requirement for nasal high-flow oxygen for participants receiving standard oxygen therapy.
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Assessment method [6]
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Assessed via electronic medical records for presence of the outcome.
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Timepoint [6]
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Assessed daily within 7 days post-operatively.
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Secondary outcome [7]
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Primary outcome: occurrence of postoperative pulmonary complication (PPC) Acute Respiratory Distress Syndrome determined by the Berlin consensus definition (or reintubation within 30 days).
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Assessment method [7]
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Assessed via electronic medical records for the following: • Timing: within 1 week of a known clinical insult or new or worsening respiratory symptoms AND… • Chest imaging: bilateral opacities not fully explained by effusions, lobar/lung collapse or nodules AND… • Origin of oedema: respiratory failure not fully explained by cardiac failure or fluid overload (requires objective assessment, e.g. echocardiography, to exclude hydrostatic oedema), AND… • Oxygenation: o mild PaO2:FiO2 between 26.7 and 40.0 kPa (200 to 300 mm Hg) with PEEP or CPAP equal to 5 cm H2O o moderate PaO2:FiO2 between 13.3 and 26.6 kPa (100 to 200 mm Hg) with PEEP equal to 5 cm H2O o severe PaO2:FiO2 equal to 13.3 kPa (100 mm Hg) with PEEP equal to 5 cm H2O.
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Timepoint [7]
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Assessed daily within 7 days postoperatively.
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Secondary outcome [8]
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Primary outcome: occurrence of postoperative pulmonary complication (PPC) pulmonary aspiration.
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Assessment method [8]
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Assessed via electronic medical records for the following: Clear clinical history AND radiological evidence (computed tomography or chest radiograph).
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Timepoint [8]
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Assessed daily within 7 days postoperatively.
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Eligibility
Key inclusion criteria
As per NOTACS study criteria:
• Adult patients undergoing cardiac surgery with cardiopulmonary bypass
• One or more risk factors of post-operative pulmonary complications: 1. Chronic Obstructive Pulmonary Disease, 2. Asthma, 3. Lower respiratory tract infection in last four weeks, 4. Body mass index greater than or equal to 35kg/m2, 5. Current (within the last six weeks) heavy smokers (>10 pack years)
No additional inclusion / exclusion criteria were set for this sub-study.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Deep-hypothermic circulatory arrest planned
• Requirement for home ventilatory support (e.g. home continuous positive airway pressure for obstructive sleep apnoea)
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Study design
Purpose
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Duration
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Logistic regression analysis will be used to assess the association between pre-extubation LUS score and PPC. Potential confounders (age, sex, type of respiratory risk factor (COPD, asthma, recent lower respiratory tract infection in the last four weeks as defined by use of antibiotics, body mass index greater than or equal to 35 kg/m2, current (within last 6 weeks) heavy smokers (>10 pack years) and duration of mechanical ventilation)) of the association will be tested. Receiver operating characteristic (ROC) analysis will be used to determine the AUC, sensitivity, specificity and positive and negative predictive values of LUS in predicting PPC. The association between change in LUS aeration score and PPC, adjusting for baseline LUS will also be assessed using logistic regression. Correlation between LUS and severity of PPC will be assessed using Spearman’s rank correlation coefficient.
Differences in effect estimates will be assessed by testing treatment group in the logistic regression model. If indicated, estimates will be produced stratified by treatment group. In subgroup analysis in the COT group, mean lung aeration scores will be compared by whether or not traditional respiratory support failed.
Other outcomes of interest will be reported using descriptive statistics. Continuous measures will be summarized using the mean (SD) or median (IQR) as appropriate and categorical variables will be summarized using frequency (%). Lung aeration scores (pre-extubation, post-extubation and change between timepoints), baseline patient characteristics, duration of intubation and intervention status (NHFO or COT) will be compared between groups using Student’s t-test, Wilcoxon’s rank-sum test or Pearson’s chi-square or Fisher’s exact test as appropriate.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
23/05/2023
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Date of last participant enrolment
Anticipated
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Actual
30/05/2024
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Date of last data collection
Anticipated
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Actual
29/08/2024
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Sample size
Target
120
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Accrual to date
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Final
120
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
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Recruitment hospital [1]
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The Prince Charles Hospital - Chermside
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Recruitment hospital [2]
28463
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [3]
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Royal North Shore Hospital - St Leonards
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Recruitment postcode(s) [1]
44698
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4032 - Chermside
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Recruitment postcode(s) [2]
44699
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6150 - Murdoch
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Recruitment postcode(s) [3]
44700
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2065 - St Leonards
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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The Common Good Foundation
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
The Prince Charles Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
322481
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Country [1]
322481
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
318485
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Metro South Human Research Ethics Committee
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Ethics committee address [1]
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https://www.metrosouth.health.qld.gov.au/research/research-ethics-and-governance/human-research-ethics-committee
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Ethics committee country [1]
318485
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Australia
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Date submitted for ethics approval [1]
318485
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06/11/2022
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Approval date [1]
318485
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21/11/2022
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Ethics approval number [1]
318485
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HREC/2022/QMS/79359
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Summary
Brief summary
The focus of this study is to determine whether lung ultrasound (LUS) can predict poor lung outcomes in high-risk patients undergoing cardiac surgery and guide decisions for optimal oxygen delivery methods. This study will be a sub-study within the larger Nasal High-Flow Oxygen Therapy After Cardiac Surgery (NOTACS) Trial (registration record: NCT05308719), ethics registration record, SSA/2021/MNHHS/81052. Whilst cardiac surgery can provide several long-term benefits, the surgery is not without risks. Incidences of post-operative pulmonary complications (PPCs) (or lung complications) for patients undergoing open-heart surgery range from 5-90% depending on the definition of the complication. The identification of risk factors for developing PPCs and early diagnosis in the cardiac surgery population is of major importance. LUS has emerged as an excellent diagnostic tool in identifying a variety of pulmonary diseases and PPCs. We hypothesise that LUS will be an accurate predictor of PPCs and guide optimal respiratory support (oxygen therapy) in the high-risk cardiac surgery population.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Luke Churchill
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Address
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The Prince Charles Hospital, Rode Rd, CHERMSIDE, QLD, 4032
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Country
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Australia
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Phone
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+61 409876227
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Fax
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Email
144354
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[email protected]
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Contact person for public queries
Name
144355
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Luke Churchill
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Address
144355
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The Prince Charles Hospital, Rode Rd, CHERMSIDE, QLD, 4032
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Country
144355
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Australia
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Phone
144355
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+61 409876227
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Fax
144355
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Email
144355
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[email protected]
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Contact person for scientific queries
Name
144356
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Luke Churchill
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Address
144356
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The Prince Charles Hospital, Rode Rd, CHERMSIDE, QLD, 4032
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Country
144356
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Australia
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Phone
144356
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+61 409876227
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Fax
144356
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Email
144356
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Researchers
Conditions for requesting access:
•
Yes, conditions apply:
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Requires a scientifically sound proposal or protocol
What individual participant data might be shared?
•
All de-identified individual participant data
What types of analyses could be done with individual participant data?
•
Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
•
Corresponding author email:
[email protected]
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Ethical approval
79359 Ethical Clearance Letter.pdf
Ethical approval
79359 TPCH SSA Approval LTR_.pdf
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.
Download to PDF