Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12616001020471
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
31/07/2016
Date registered
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2/08/2016
Date last updated
Help: Date last updated
26/02/2026
Date data sharing statement initially provided
Help: Data sharing statement date
17/12/2018
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
CHESTY (CHEST infection prevalence following surgerY): Incidence of respiratory complications in adults following major surgery.
Scientific title
CHESTY: An international multi-center observational trial investigating the incidence of respiratory complications in adults following major surgery.
Additional trial identifiers [1] 289803 0
Nil
Universal Trial Number (UTN)
U1111-1185-9333
Trial acronym
CHESTY
Related trial records

Health condition
Health condition(s) studied:
Respiratory complications 299713 0
Pneumonia 299714 0
Systemic Inflammatory Response Syndrome (SIRS) 310842 0
Sepsis (SOFA) 310843 0
Condition category
Condition code
Surgery 299648 299648 0 0
Other surgery
Respiratory 299649 299649 0 0
Other respiratory disorders / diseases
Physical Medicine / Rehabilitation 299650 299650 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of the intervention or exposure
Eligible patients are screened prospectively from the day of surgery using standardized diagnostic criteria for a postoperative respiratory complication, systemic inflammatory response syndrome and sepsis till the 7th post-operative day, or till discharge from hospital whichever occurs first.
Intervention code [1] 295475 0
Early Detection / Screening
Intervention code [2] 295477 0
Diagnosis / Prognosis
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299116 0
% who develop a Post-operative Pulmonary Complication as diagnosed with the following criteria: When four (4) or more of the following criteria are present 1. Chest radiograph report of collapse/consolidation 2. Raised maximum tympanic temperature greater than 38.0 C on more than one consecutive post-operative day 3. Pulse oximetry oxygen saturation (Sp02) less than 90% on room air on more than one consecutive post-operative day 4. Production of yellow, green or brown sputum different to pre-operative assessment 5. Presence of infection on sputum culture report 6. An otherwise unexplained white cell count greater than 11,000, or less than 3. 7. New abnormal breath sounds on auscultation different to preoperative assessment 8. Physician’s diagnosis of postoperative pulmonary complication OR prescription of antibiotic specific for respiratory infection.
Timepoint [1] 299116 0
Daily measure until post-operative day 7 or discharge from hospital, whichever occurs first.
Primary outcome [2] 299117 0
Pneumonia (WHO definition) - defined as new CXR infiltrates with at least two of: temp >38 degrees Celsius, SOB, cough and purulent sputum, altered respiratory auscultation and WCC >12,000/ml or leukopenia <3000/ml)
Timepoint [2] 299117 0
Daily measure until post-operative day 7 or discharge from hospital, whichever occurs first.
Secondary outcome [1] 326225 0
Systemic Inflammatory Response Syndrome – 2 or more of the following criteria: temp >38 or <36; HR>90; RR>20, or PCO2<32, or ventilation for acute process; WCC>12 or <4
Timepoint [1] 326225 0
Daily measure until post-operative day 7 or discharge from hospital, whichever occurs first.
Secondary outcome [2] 326226 0
Sepsis – Defined focus of infection and at least two SIRS criteria. Defined focus of infection is indicate by either an organism grown in blood or sterile site, abscess, infected tissue, respiratory infection, UTI, line infection, soft tissue infection etc.
Timepoint [2] 326226 0
Daily measure until post-operative day 7 or discharge from hospital, whichever occurs first.
Secondary outcome [3] 326230 0
All-cause In-hospital mortality
Timepoint [3] 326230 0
Daily screen until this endpoint is reached or till discharge from hospital.
Secondary outcome [4] 326232 0
Re-intubation rates
Timepoint [4] 326232 0
Assessed by review of medical records till discharge from hospital.
Secondary outcome [5] 326278 0
Unplanned ICU/HDU admission from surgical ward
Timepoint [5] 326278 0
Assessed daily from review of medical records till discharged from hospital
Secondary outcome [6] 326279 0
Intensive care length of stay
Timepoint [6] 326279 0
Assessed from review of medical records till discharged from hospital
Secondary outcome [7] 326280 0
Preoperative length of stay
Timepoint [7] 326280 0
Assessed from review of medical records till discharged from hospital
Secondary outcome [8] 458206 0
Postoperative length of stay
Timepoint [8] 458206 0
The number of days from the day of surgery until discharge from acute hospital care collected from review of medical records.
Secondary outcome [9] 458207 0
Sub-acute length of stay
Timepoint [9] 458207 0
From the day after discharge from an acute hospital to the day of discharge from a sub-acute hospital collected from review of medical records.
Secondary outcome [10] 458208 0
Discharge destination
Timepoint [10] 458208 0
On the day of discharge from acute hospital collected from review of medical records.
Secondary outcome [11] 458209 0
Pneumonia - US Centers for Disease Control diagnostic definition 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): (i) New or progressive and persistent infiltrates, (ii) consolidation, (iii) cavitation; AND at least one of the following: (a) fever (>38 degrees Celsius) with no other recognised cause, (b) leucopaenia (white cell count 12 000/ml), (c) for adults >70 yr old, altered mental status with no other recognised cause; AND at least two of the following: (a) new onset of purulent sputum or change in character of sputum, or increased respiratory secretions, or increased suctioning requirements, (b) new onset or worsening cough, or dyspnoea, or tachypnoea, (c) rales or bronchial breath sounds, (d) worsening gas exchange (hypoxaemia, increased oxygen requirement, increased ventilator demand).
Timepoint [11] 458209 0
From the day of surgery until the 7th postoperative day or discharge from acute hospital, whichever occurred first.
Secondary outcome [12] 458210 0
StEP-COMPAC Postoperative Pulmonary Complication (PPC) diagnosis Composite of respiratory diagnoses that share common pathophysiological mechanisms including pulmonary collapse and airway contamination: (i) atelectasis detected on computed tomography or chest radiograph, (ii) pneumonia using US Centers for Disease Control criteria, (iii) Acute Respiratory Distress Syndrome using Berlin consensus definition, (iv) pulmonary aspiration (clear clinical history AND radiological evidence). Severity 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. Therapies which are purely preventive or prophylactic for example high flow nasal oxygen or continuous positive airways pressure (CPAP) should be recorded as none Mild: therapeutic supplemental oxygen <0.6 FiO2 Moderate: therapeutic supplemental oxygen 0.6 FiO2, requirement for high-flow nasal oxygen, or both Severe: unplanned non-invasive mechanical ventilation, CPAP, or invasive mechanical ventilation requiring tracheal intubation
Timepoint [12] 458210 0
From day of surgery until the 7th postoperative day, or discharge from acute hospital, whichever occurred first.

Eligibility
Key inclusion criteria
All adults having emergency and elective surgery involving a surgical incision/s anywhere in the abdomen, thorax, spine, or head, with a minimum of a two (2) night hospital stay fitting the following hierarchical criteria;

1. All surgical patients admitted to ICU/HDU postoperatively.
Including, but not limited to, transplants, abdominal, thoracic, cardiac, neurosurgery, ENT, spinal, trauma.
2. Surgical patients admitted to an acute surgical ward with the following operations:
Open* upper abdominal surgery, open vascular abdominal surgery, laparoscopic assisted or hand-assisted abdominal surgery, advanced laparoscopic surgery (colorectal, UGI, bariatric surgery), open cardiac surgery, open thoracic surgery
3. Only when anaesthetic time is >180mins and admitted to a surgical ward.
Open lower abdominal surgery, abdominal/thoracic laparoscopic** surgery, neuro surgery, spinal surgery.
*Open procedure – where any incision greater than or equal to 5cm, or where the combined length of laparoscopic incisions is greater than or equal to 5cm
**Laparoscopic procedure – where each incision is <5cm and the combined length of incisions are <5cm
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Where the procedure is solely a gynaecological procedure, inguinal hernia repair, peripheral orthopaedic surgery, burns grafting, currently recruited CHESTY patients who have had repeat surgical procedure/s within the primary episode of care for which they were originally included in CHESTY, and patients whose surgery did not occur on-site or those admitted to day-surgery unit or short-stay surgical unit.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
To measure sub-group analysis of different surgical groups with an estimated range of respiratory complication prevalence of 10-80% will require a minimum sample of 5000. A minimum sample of 5000 will also provide 99% power to detect an association between variables in a 30 factor model with an odds ratio >1.1 as statistically significant (two-tailed) given a multiple partial correlation of 0.08 in a hierarchical multivariate regression analysis, including site as a random effect, to investigate the relationship between perioperative factors and the onset of a postoperative respiratory complication.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/02/2017
Actual
6/02/2017
Date of last participant enrolment
Anticipated
23/12/2019
Actual
30/10/2020
Date of last data collection
Anticipated
31/12/2019
Actual
6/11/2020
Sample size
Target
4000
Accrual to date
Final
5200
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 6324 0
Launceston General Hospital - Launceston
Recruitment hospital [2] 6325 0
Royal Hobart Hospital - Hobart
Recruitment hospital [3] 6327 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [4] 6328 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [5] 6329 0
Northeast Health Wangaratta - Wangaratta
Recruitment hospital [6] 6331 0
The Canberra Hospital - Garran
Recruitment hospital [7] 6332 0
Wollongong Hospital - Wollongong
Recruitment hospital [8] 6334 0
Gold Coast Hospital - Southport
Recruitment hospital [9] 6335 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [10] 6336 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [11] 6339 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [12] 6342 0
Melbourne Private Hospital - Parkville
Recruitment hospital [13] 12747 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [14] 12748 0
Coffs Harbour Base Hospital - Coffs Harbour
Recruitment hospital [15] 12749 0
Albury Wodonga Health - Albury campus - Albury
Recruitment hospital [16] 12750 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [17] 12751 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [18] 12752 0
Logan Hospital - Meadowbrook
Recruitment hospital [19] 12753 0
St George Hospital - Kogarah
Recruitment hospital [20] 12754 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [21] 12756 0
Liverpool Hospital - Liverpool
Recruitment hospital [22] 12757 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment hospital [23] 12758 0
Gosford Hospital - Gosford
Recruitment hospital [24] 12759 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [25] 29199 0
St John of God Hospital, Murdoch - Murdoch
Recruitment hospital [26] 29200 0
St John of God Hospital, Subiaco - Subiaco
Recruitment postcode(s) [1] 13859 0
7250 - Launceston
Recruitment postcode(s) [2] 13860 0
7000 - Hobart
Recruitment postcode(s) [3] 13862 0
3050 - Parkville
Recruitment postcode(s) [4] 13863 0
3168 - Clayton
Recruitment postcode(s) [5] 13864 0
3677 - Wangaratta
Recruitment postcode(s) [6] 13866 0
2605 - Garran
Recruitment postcode(s) [7] 13867 0
2500 - Wollongong
Recruitment postcode(s) [8] 13869 0
4215 - Southport
Recruitment postcode(s) [9] 13870 0
4102 - Woolloongabba
Recruitment postcode(s) [10] 13871 0
6150 - Murdoch
Recruitment postcode(s) [11] 13874 0
3000 - Melbourne
Recruitment postcode(s) [12] 13876 0
3052 - Parkville
Recruitment postcode(s) [13] 25176 0
4029 - Herston
Recruitment postcode(s) [14] 25177 0
2450 - Coffs Harbour
Recruitment postcode(s) [15] 25178 0
2640 - Albury
Recruitment postcode(s) [16] 25179 0
3084 - Heidelberg
Recruitment postcode(s) [17] 25180 0
3065 - Fitzroy
Recruitment postcode(s) [18] 25181 0
4131 - Meadowbrook
Recruitment postcode(s) [19] 25182 0
2217 - Kogarah
Recruitment postcode(s) [20] 25183 0
2109 - Macquarie Park
Recruitment postcode(s) [21] 25185 0
2170 - Liverpool
Recruitment postcode(s) [22] 25186 0
2077 - Hornsby
Recruitment postcode(s) [23] 25187 0
2250 - Gosford
Recruitment postcode(s) [24] 25188 0
5042 - Bedford Park
Recruitment postcode(s) [25] 45508 0
6150 - Murdoch
Recruitment postcode(s) [26] 45509 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 8065 0
New Zealand
State/province [1] 8065 0
Auckland/Wellington
Country [2] 21133 0
Sweden
State/province [2] 21133 0
Sahlgrenska/Södersjukhuset / Orebro
Country [3] 24241 0
Canada
State/province [3] 24241 0
Quebec
Country [4] 24242 0
Malaysia
State/province [4] 24242 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 294190 0
Hospital
Name [1] 294190 0
Launceston General Hospital
Country [1] 294190 0
Australia
Primary sponsor type
Hospital
Name
Launceston General Hospital
Address
PO BOX 1963
Launceston
Tasmanian 7250
Country
Australia
Secondary sponsor category [1] 293015 0
Charities/Societies/Foundations
Name [1] 293015 0
Clifford Craig Foundation
Address [1] 293015 0
PO BOX 1963 Launceston TAS 7250
Country [1] 293015 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295593 0
Tasmanian Human Research Ethics Committee
Ethics committee address [1] 295593 0
Ethics committee country [1] 295593 0
Australia
Date submitted for ethics approval [1] 295593 0
05/08/2016
Approval date [1] 295593 0
05/01/2017
Ethics approval number [1] 295593 0
H0016029

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

Contacts
Principal investigator
Name 67866 0
Ms Ianthe Boden
Address 67866 0
Physiotherapy Department Launceston General Hospital PO BOX 1963 Launceston, Tasmanian 7250
Country 67866 0
Australia
Phone 67866 0
+61 3 6777 7216
Fax 67866 0
Email 67866 0
[email protected]
Contact person for public queries
Name 67867 0
Ianthe Boden
Address 67867 0
Physiotherapy Department Launceston General Hospital PO BOX 1963 Launceston, Tasmanian 7250
Country 67867 0
Australia
Phone 67867 0
+61 3 6777 7216
Fax 67867 0
Email 67867 0
[email protected]
Contact person for scientific queries
Name 67868 0
Ianthe Boden
Address 67868 0
Physiotherapy Department Launceston General Hospital PO BOX 1963 Launceston, Tasmanian 7250
Country 67868 0
Australia
Phone 67868 0
+61 3 6777 7216
Fax 67868 0
Email 67868 0
[email protected]

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:
• Case-by-case basis at discretion of Chief Investigator who provide a methodologically sound proposal.

Conditions for requesting access:
• -

What individual participant data might be shared?
• All deidentified data individual level data as specified in methods and protocol paper (open access)

What types of analyses could be done with individual participant data?
• to achieve the aims in the approved proposal e.g for IPD meta-analyses

When can requests for individual participant data be made (start and end dates)?
From:
2 years following publication of primary paper and main secondary papers. No end date determined.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• requirement to sign data access agreement and meet all ethical requirements.

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    Study-related document.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCritical appraisal on the impact of preoperative rehabilitation and outcomes after major abdominal and cardiothoracic surgery: A systematic review and meta-analysis: Counting rules are critical.2020https://dx.doi.org/10.1016/j.surg.2020.04.028
N.B. These documents automatically identified may not have been verified by the study sponsor.