Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001020471
Ethics application status
Approved
Date submitted
31/07/2016
Date registered
2/08/2016
Date last updated
22/10/2021
Date data sharing statement initially provided
17/12/2018
Date results information initially provided
22/10/2021
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.
Secondary ID [1] 289803 0
Nil
Universal Trial Number (UTN)
U1111-1185-9333
Trial acronym
CHESTY
Linked study record

Health condition
Health condition(s) or problem(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 intervention(s) / exposure
Eligible patients are screened prospectively from the first postoperative day using standardized diagnostic criteria for a postoperative respiratory complication till the 7th postoperative day and for systemic inflammatory response syndrome and sepsis till the 14th 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
Comparator / control treatment
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 or green 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 prescription of an antibiotic specific for respiratory infection
7. New abnormal breath sounds on auscultation different to preoperative assessment
8. Physician’s diagnosis of postoperative pulmonary complication
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 >14,000/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 14 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 14 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
Total hospital length of stay
Timepoint [7] 326280 0
Assessed from review of medical records till discharged from hospital

Eligibility
Key inclusion criteria
Adults
Emergency and elective surgery
Minimum overnight stay
All organ transplants (including autologous)
All open upper abdominal surgery
All open vascular abdominal surgery
All laparoscopic assisted or hand-assisted abdominal surgery
All advanced laparoscopic surgery (colorectal, UGI, bariatric surgery)
All open cardiac surgery
All open thoracic surgery
All major neurosurgery
Major ENT surgery
All abdominal hernia repairs
Spinal surgery (orthopaedic +/- neuro)
Open lower abdominal surgery > 180mins (ULAR, prostatectomies, cystectomies etc)
Standard laparoscopic surgery > 180mins (Lap choles, lap hiatus hernia repairs etc)
Optional inclusion (site to determine capacity to collect data): Multi-trauma without abdo/thoracic open surgical intervention
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Gynaecological surgery
Inguinal hernia repairs
Peripheral orthopaedic surgery

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,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] 6337 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [12] 6338 0
Wagga Wagga Base Hospital - Wagga Wagga
Recruitment hospital [13] 6339 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [14] 6342 0
Melbourne Private Hospital - Parkville
Recruitment hospital [15] 12747 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [16] 12748 0
Coffs Harbour Base Hospital - Coffs Harbour
Recruitment hospital [17] 12749 0
Albury Wodonga Health - Albury campus - Albury
Recruitment hospital [18] 12750 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [19] 12751 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [20] 12752 0
Logan Hospital - Meadowbrook
Recruitment hospital [21] 12753 0
St George Hospital - Kogarah
Recruitment hospital [22] 12754 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [23] 12755 0
Concord Repatriation Hospital - Concord
Recruitment hospital [24] 12756 0
Liverpool Hospital - Liverpool
Recruitment hospital [25] 12757 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment hospital [26] 12758 0
Gosford Hospital - Gosford
Recruitment hospital [27] 12759 0
Flinders Medical Centre - Bedford Park
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] 13873 0
2650 - Wagga Wagga
Recruitment postcode(s) [12] 13874 0
3000 - Melbourne
Recruitment postcode(s) [13] 13876 0
3052 - Parkville
Recruitment postcode(s) [14] 25176 0
4029 - Herston
Recruitment postcode(s) [15] 25177 0
2450 - Coffs Harbour
Recruitment postcode(s) [16] 25178 0
2640 - Albury
Recruitment postcode(s) [17] 25179 0
3084 - Heidelberg
Recruitment postcode(s) [18] 25180 0
3065 - Fitzroy
Recruitment postcode(s) [19] 25181 0
4131 - Meadowbrook
Recruitment postcode(s) [20] 25182 0
2217 - Kogarah
Recruitment postcode(s) [21] 25183 0
2109 - Macquarie Park
Recruitment postcode(s) [22] 25184 0
2139 - Concord
Recruitment postcode(s) [23] 25185 0
2170 - Liverpool
Recruitment postcode(s) [24] 25186 0
2077 - Hornsby
Recruitment postcode(s) [25] 25187 0
2250 - Gosford
Recruitment postcode(s) [26] 25188 0
5042 - Bedford Park
Recruitment outside Australia
Country [1] 8065 0
New Zealand
State/province [1] 8065 0
Auckland
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
Office of Research Services
Private Bag 1
Hobart TAS 7001
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
Post-operative pulmonary complications (PPC) are the most common complication following upper abdominal surgery (UAS).. Recent unpublished data from a large international multi-centre randomised control trial (LIPPSMAck POP; Boden 2015) found that patients who develop a PPC following major upper abdominal surgery had a mean LOS five days longer, cost an additional $AUD18,000 per episode, and have a significantly higher 30-day mortality rate (9% v 1%, p=0.01) compared to those without a PPC. This is in keeping with meta-analysis data of mortality attributable to postoperative acute lung injury (Neto 2014).
Previously reported PPC incidence rates following abdominal surgery vary greatly (anywhere between 10 and 80%). This variance is mostly due to two factors; firstly, the patient group being investigated (for example low risk hernia repair compared to higher risk oesophagectomy) and secondly, the diagnostic criteria used to detect a PPC. There is also limited current prospective evidence to estimate the PPC rate in surgical groups other than elective major abdominal surgery. This includes emergency surgery, organ transplant, neurosurgery, cardiac, thoracic, ENT surgery, and minimally invasive abdominal surgery. The combination of non-standardised measurement of PPC incidence and lack of contemporary incidence rates outside of abdominal surgery means that it is not possible to accurately estimate which surgical groups are at highest risk of developing a PPC. It also means that resource allocation of prophylactic interventions like physiotherapy is not based upon robust evidence. Hospitals could be over-treating some surgical groups and most concerning, under-treating others. This is unknown, as the current physiotherapy practice for these surgical groups has also not been measured robustly (audit rather than survey) and what impact this may have on PPC rate, mortality, and LOS.
Considering the high morbidity, mortality, and cost impact of a PPC there is an urgent need to measure PPC prevalence using consistent diagnostic criteria, over a range of hospital types and surgical groups, and a need to investigate the current use of physiotherapy interventions to reduce PPC incidence and improve recovery following major non-orthopaedic surgery.
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
Ms 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
Ms 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 individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All deidentified data individual level data as specified in methods and protocol paper (open access)
When will data be available (start and end dates)?
2 years following publication of primary paper and main secondary papers. No end date determined.
Available to whom?
Case-by-case basis at discretion of Chief Investigator who provide a methodologically sound proposal.
Available for what types of analyses?
to achieve the aims in the approved proposal e.g for IPD meta-analyses
How or where can data be obtained?
requirement to sign data access agreement and meet all ethical requirements.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
792Study protocol    371202-(Uploaded-15-12-2018-13-04-05)-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.