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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

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]

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

Pneumonia

Systemic Inflammatory Response Syndrome (SIRS)

Sepsis (SOFA)

Condition category

Condition code

Surgery

Other surgery

Respiratory

Other respiratory disorders / diseases

Physical Medicine / Rehabilitation

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]

Early Detection / Screening

Intervention code [2]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

% 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]

Daily measure until post-operative day 7 or discharge from hospital, whichever occurs first.

Primary outcome [2]

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]

Daily measure until post-operative day 7 or discharge from hospital, whichever occurs first.

Secondary outcome [1]

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]

Daily measure until post-operative day 14 or discharge from hospital, whichever occurs first.

Secondary outcome [2]

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]

Daily measure until post-operative day 14 or discharge from hospital, whichever occurs first.

Secondary outcome [3]

All-cause In-hospital mortality

Timepoint [3]

Daily screen until this endpoint is reached or till discharge from hospital.

Secondary outcome [4]

Re-intubation rates

Timepoint [4]

Assessed by review of medical records till discharge from hospital.

Secondary outcome [5]

Unplanned ICU/HDU admission from surgical ward

Timepoint [5]

Assessed daily from review of medical records till discharged from hospital

Secondary outcome [6]

Intensive care length of stay

Timepoint [6]

Assessed from review of medical records till discharged from hospital

Secondary outcome [7]

Total hospital length of stay

Timepoint [7]

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?

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]

Launceston General Hospital - Launceston

Recruitment hospital [2]

Royal Hobart Hospital - Hobart

Recruitment hospital [3]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [4]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [5]

Northeast Health Wangaratta - Wangaratta

Recruitment hospital [6]

The Canberra Hospital - Garran

Recruitment hospital [7]

Wollongong Hospital - Wollongong

Recruitment hospital [8]

Gold Coast Hospital - Southport

Recruitment hospital [9]

Princess Alexandra Hospital - Woolloongabba

Recruitment hospital [10]

Fiona Stanley Hospital - Murdoch

Recruitment hospital [11]

Sir Charles Gairdner Hospital - Nedlands

Recruitment hospital [12]

Wagga Wagga Base Hospital - Wagga Wagga

Recruitment hospital [13]

Peter MacCallum Cancer Centre - Melbourne

Recruitment hospital [14]

Melbourne Private Hospital - Parkville

Recruitment hospital [15]

Royal Brisbane & Womens Hospital - Herston

Recruitment hospital [16]

Coffs Harbour Base Hospital - Coffs Harbour

Recruitment hospital [17]

Albury Wodonga Health - Albury campus - Albury

Recruitment hospital [18]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [19]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment hospital [20]

Logan Hospital - Meadowbrook

Recruitment hospital [21]

St George Hospital - Kogarah

Recruitment hospital [22]

Macquarie University Hospital - Macquarie Park

Recruitment hospital [23]

Concord Repatriation Hospital - Concord

Recruitment hospital [24]

Liverpool Hospital - Liverpool

Recruitment hospital [25]

Hornsby Ku-ring-gai Hospital - Hornsby

Recruitment hospital [26]

Gosford Hospital - Gosford

Recruitment hospital [27]

Flinders Medical Centre - Bedford Park

Recruitment postcode(s) [1]

7250 - Launceston

Recruitment postcode(s) [2]

7000 - Hobart

Recruitment postcode(s) [3]

3050 - Parkville

Recruitment postcode(s) [4]

3168 - Clayton

Recruitment postcode(s) [5]

3677 - Wangaratta

Recruitment postcode(s) [6]

2605 - Garran

Recruitment postcode(s) [7]

2500 - Wollongong

Recruitment postcode(s) [8]

4215 - Southport

Recruitment postcode(s) [9]

4102 - Woolloongabba

Recruitment postcode(s) [10]

6150 - Murdoch

Recruitment postcode(s) [11]

2650 - Wagga Wagga

Recruitment postcode(s) [12]

3000 - Melbourne

Recruitment postcode(s) [13]

3052 - Parkville

Recruitment postcode(s) [14]

4029 - Herston

Recruitment postcode(s) [15]

2450 - Coffs Harbour

Recruitment postcode(s) [16]

2640 - Albury

Recruitment postcode(s) [17]

3084 - Heidelberg

Recruitment postcode(s) [18]

3065 - Fitzroy

Recruitment postcode(s) [19]

4131 - Meadowbrook

Recruitment postcode(s) [20]

2217 - Kogarah

Recruitment postcode(s) [21]

2109 - Macquarie Park

Recruitment postcode(s) [22]

2139 - Concord

Recruitment postcode(s) [23]

2170 - Liverpool

Recruitment postcode(s) [24]

2077 - Hornsby

Recruitment postcode(s) [25]

2250 - Gosford

Recruitment postcode(s) [26]

5042 - Bedford Park

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Country [2]

Sweden

State/province [2]

Sahlgrenska/Södersjukhuset / Orebro

Country [3]

Canada

State/province [3]

Quebec

Country [4]

Malaysia

State/province [4]

Kuala Lumpur

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Launceston General Hospital

Address [1]

PO BOX 1963
Launceston
Tasmanian 7250

Country [1]

Australia

Primary sponsor type

Hospital

Name

Launceston General Hospital

Address

PO BOX 1963
Launceston
Tasmanian 7250

Country

Australia

Secondary sponsor category [1]

Charities/Societies/Foundations

Name [1]

Clifford Craig Foundation

Address [1]

PO BOX 1963
Launceston TAS 7250

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Tasmanian Human Research Ethics Committee

Ethics committee address [1]

Office of Research Services
Private Bag 1
Hobart TAS 7001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/08/2016

Approval date [1]

05/01/2017

Ethics approval number [1]

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

Ms Ianthe Boden

Address

Physiotherapy Department
Launceston General Hospital
PO BOX 1963
Launceston,
Tasmanian 7250

Country

Australia

Phone

+61 3 6777 7216

Fax

ianthe.boden@ths.tas.gov.au

Contact person for public queries

Name

Ianthe Boden

Address

Physiotherapy Department
Launceston General Hospital
PO BOX 1963
Launceston,
Tasmanian 7250

Country

Australia

Phone

+61 3 6777 7216

Fax

ianthe.boden@ths.tas.gov.au

Contact person for scientific queries

Name

Ianthe Boden

Address

Physiotherapy Department
Launceston General Hospital
PO BOX 1963
Launceston,
Tasmanian 7250

Country

Australia

Phone

+61 3 6777 7216

Fax

ianthe.boden@ths.tas.gov.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?

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.	Type	Citation	Link	Email	Other Details	Attachment
792	Study 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

Source	Title	Year of Publication	DOI
Embase	Critical 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.	2020	https://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.

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