ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622001392752p

Ethics application status

Submitted, not yet approved

Date submitted

19/10/2022

Date registered

31/10/2022

Date last updated

31/10/2022

Date data sharing statement initially provided

31/10/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Effects of compression of front of chest on mechanically ventilated patients with breathing machine

Scientific title

Effects of anterior chest wall compression on mechanically ventilated patients

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Intubate and Mechanically ventilated adult patients

PaO2/FiO2 >/ 300 with PEEP </5

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Patient will have a 100 gm/kg weight placed on the anterior chest wall, while in supine position. The weight will be placed on the patients’ chest wall for 10 minutes and then removed. A number of measurements will be recorded before and after the procedure. Similar intervention repeated during CT chest.

Device: 100 gm/kg soft and smooth weight (saline bags) placed and secure around each hemithorax
Member of study team will be delivering the intervention.
The period between the first session of study and the CT session will be at least 1 hour.
The total amount of time involved per session for all measurements and procedure to be completed would be around 1 hour.

Intervention code [1]

Prevention

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Difference in regional overdistention of lung before and after application of anterior chest wall compression. Overdistention will be assessed with the help of CT chest.

Timepoint [1]

Baseline (pre-intervention) and 10 minutes after application of anterior chest wall compression

Secondary outcome [1]

Difference in oxygenation before and after application of anterior chest wall compression
by measuring Pulse oximetry ( SPO2), Arterial blood gas oxygen saturation ( SaO2)

Timepoint [1]

Baseline (pre-intervention) and 10 minutes after application of anterior chest wall compression

Secondary outcome [2]

Difference in respiratory system compliance before and after application of anterior chest wall compression
By ventilator parameters e.g. PPeak, PPlateau,Driving pressure ( PPlateau -PEEP), Intrinsic PEEP, Flow

Timepoint [2]

Baseline (pre-intervention) and 10 minutes after application of anterior chest wall compression

Secondary outcome [3]

Difference in dead space before and after application of anterior chest wall compression.
By measuring PaCO2 ( ABG) and End tidal CO2 ( ETCO2), using Bohr equation

Timepoint [3]

Baseline (pre-intervention) and 10 minutes after application of anterior chest wall compression

Eligibility

Key inclusion criteria

Inclusion

Patients who are 18 years or older admitted to the ICU at Flinders Medical Centre who have been identified as either of the following
1. Intubated and ventilated
2. PaO2/FiO2 greater than or equal to 300 with PEEP less than or equal to 5

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. History of chronic respiratory condition (COPD/Interstitial lung disease) or any suspected lung infection
2. Current lung collapse, pleural effusion, pneumothorax, pulmonary embolism, chest trauma
3. Chest drain
4. Unstable spine, femur or pelvic fractures
5. Cardiovascular unstable -MAP < 65 mmHg despite ongoing high vasopressor /inotropic support, arrhythmias
6. Recent cardiothoracic surgery ( 4 weeks)
7. Patients who are admitted to ICU with active palliation
8. Admitted consultant is not happy for the patient to be enrolled in this study
9. Intracranial pressure > 20 mmHg or Cerebral perfusion pressure < 60 mmHg
10. Pregnant women

Study design

Purpose of the study

Prevention

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Not applicable

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

All analyses will be performed using the SAS software version 9.4 (SAS Institute, Cary, NC, USA). Student t-test for normally distributed continuous variables, Wilcoxon rank-sum test for non-normally distributed continuous variables and chi-square or Fisher’s exact test as appropriate for categorical variables, with results presented as mean (standard error), median (interquartile range) and number (percentage) respectively. A two-sided p value of 0.05 will be used to indicate statistical significance.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

12/12/2022

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)

Recruitment hospital [1]

Flinders Medical Centre - Bedford Park

Recruitment postcode(s) [1]

5042 - Bedford Park

Recruitment postcode(s) [2]

5042 - Flinders University

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Flinders Medical Centre

Address [1]

1 Flinders Drive
Bedford Park
SA 5042

Country [1]

Australia

Primary sponsor type

Hospital

Name

Flinders Medical Centre

Address

1 Flinders Drive
Bedford Park
SA 5042

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Southern Adelaide Clinical Human Research Ethics Committee

Ethics committee address [1]

Southern Adelaide Clinical Human Research Ethics Committee
Level 2, Flinders Medical Centre
1 Flinders Drive
Bedford Park SA 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/09/2022

Approval date [1]

Ethics approval number [1]

Summary

Brief summary


Hypothesis of this study is application of anterior chest wall compression on mechanically ventilated patients  will prevent ventral lung overdistention.
We aim to examine changes in respiratory system compliance, oxygenation, ventilation and CT changes in lungs after applying anterior chest wall compression in mechanically ventilated patients
We intend to enrol 10 patients in this single centre study.
This trial will be conducted in the Southern Adelaide Local Health Network, Intensive and Critical Care Unit, Flinders Medical Centre.
Screening and Recruitment
Patients will be referred by treating ICU clinicians. Referral will be made as soon as possible after admission for patients who are intubated and ventilated
Consent will be sought prior to enrolment 
Intervention
Patient will have a 100 gm/kg weight placed on the anterior chest wall, while in supine position. The weight will be placed on the patients’ chest wall for 10 minutes and then removed. A number of measurements will be recorded before and after the procedure. Similar intervention repeated during CT chest.
Device: weight on the anterior chest of the patient (soft and smooth weight (saline bags) placed and secure around each hemithorax)
After enrolment, each patient will be treated as follows:
Patients will be sedated and paralysed while mechanical ventilation settings will be kept unchanged over the course of the entire study.
Initial baseline in the lying on the back ( Supine)  position (T0)
10-minute period in supine position with 100 gm/kg soft and smooth weight (saline bags) placed and secure around each hemithorax (T1)
In case of drop of oxygen level ( SPO2) , increase in delivered oxygen ( FiO2)  will be allowed to achieve the previously described oxygen  target.
During the study, each patient will undergo standard ICU monitoring:

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Mitul Purushottam Chavda

Address

ICU Fellow
ICU, Level 3 ,Flinders Medical Centre,
1 Flinders Drive,
Bedford Park, SA 5042

Country

Australia

Phone

+61 449026671

Fax

drmitulchavda@yahoo.com

Contact person for public queries

Name

Mitul Purushottam Chavda

Address

ICU Fellow
ICU, SALHN
ICU, Level 3 ,Flinders Medical Centre,
1 Flinders Drive ,
Bedford Park, SA 5042

Country

Australia

Phone

+61 449026671

Fax

drmitulchavda@yahoo.com

Contact person for scientific queries

Name

Mitul Purushottam Chavda

Address

ICU Fellow
ICU, SALHN
ICU, Level 3 Flinders Medical Centre,
1 Flinders Drive ,
Bedford Park, SA 5042

Country

Australia

Phone

+61 449026671

Fax

drmitulchavda@yahoo.com

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 of the individual participant data collected during the trial, after de-identification

When will data be available (start and end dates)?

Following publication with no end date.

Available to whom?

only researchers who provide a methodologically sound proposal, case-by-case basis

Available for what types of analyses?

any purpose

How or where can data be obtained?

access subject to approvals by Principal Investigator (provide email or other contact details) through email. ( drmitulchavda@yahoo.com)

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
17403	Study protocol					384852-(Uploaded-19-10-2022-12-21-04)-Study-related document.docx

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.

Trial Review

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