Trial Review

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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] 308215 0
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 327966 0
PaO2/FiO2 >/ 300 with PEEP </5 327968 0
Condition category
Condition code
Respiratory 325029 325029 0 0
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] 324676 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332848 0
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] 332848 0

Baseline (pre-intervention) and 10 minutes after application of anterior chest wall compression
Secondary outcome [1] 414866 0
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] 414866 0
Baseline (pre-intervention) and 10 minutes after application of anterior chest wall compression
Secondary outcome [2] 415045 0
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] 415045 0
Baseline (pre-intervention) and 10 minutes after application of anterior chest wall compression
Secondary outcome [3] 415046 0
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] 415046 0
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?
No
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
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 23389 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 38787 0
5042 - Bedford Park
Recruitment postcode(s) [2] 38788 0
5042 - Flinders University

Funding & Sponsors
Funding source category [1] 312472 0
Hospital
Name [1] 312472 0
Flinders Medical Centre
Country [1] 312472 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
1 Flinders Drive
Bedford Park
SA 5042
Country
Australia
Secondary sponsor category [1] 314055 0
None
Name [1] 314055 0
Address [1] 314055 0
Country [1] 314055 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311816 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 311816 0
Southern Adelaide Clinical Human Research Ethics Committee
Level 2, Flinders Medical Centre
1 Flinders Drive
Bedford Park SA 5042
Ethics committee country [1] 311816 0
Australia
Date submitted for ethics approval [1] 311816 0
28/09/2022
Approval date [1] 311816 0
Ethics approval number [1] 311816 0

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 122466 0
Dr Mitul Purushottam Chavda
Address 122466 0
ICU Fellow
ICU, Level 3 ,Flinders Medical Centre,
1 Flinders Drive,
Bedford Park, SA 5042
Country 122466 0
Australia
Phone 122466 0
+61 449026671
Fax 122466 0
Email 122466 0
drmitulchavda@yahoo.com
Contact person for public queries
Name 122467 0
Dr Mitul Purushottam Chavda
Address 122467 0
ICU Fellow
ICU, SALHN
ICU, Level 3 ,Flinders Medical Centre,
1 Flinders Drive ,
Bedford Park, SA 5042
Country 122467 0
Australia
Phone 122467 0
+61 449026671
Fax 122467 0
Email 122467 0
drmitulchavda@yahoo.com
Contact person for scientific queries
Name 122468 0
Dr Mitul Purushottam Chavda
Address 122468 0
ICU Fellow
ICU, SALHN
ICU, Level 3 Flinders Medical Centre,
1 Flinders Drive ,
Bedford Park, SA 5042
Country 122468 0
Australia
Phone 122468 0
+61 449026671
Fax 122468 0
Email 122468 0
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.TypeCitationLinkEmailOther DetailsAttachment
17403Study protocol    384852-(Uploaded-19-10-2022-12-21-04)-Study-related document.docx



Results publications and other study-related documents

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