ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622000117718p

Ethics application status

Not yet submitted

Date submitted

15/12/2021

Date registered

24/01/2022

Date last updated

24/01/2022

Date data sharing statement initially provided

24/01/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Comparison of adaptive ventilation mode with low tidal volume mode in patients with acute respiratory distress syndrome (ARDS)- a pilot randomized cross-over study

Scientific title

Comparison of driving pressure in adaptive ventilation mode with low tidal volume mode in patients with ARDS- a pilot randomized cross-over study

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

AVM2 study

Linked study record

Health condition

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

Acute respiratory distress syndrome (ARDS)

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Before study inclusion, all patients will be ventilated with lung protective volume control ventilation (LTV). After obtaining informed consent, patients will be randomized in a 1:1 ratio to one of two groups: group I “LTV-AVM2”, first ventilated according to low tidal volume ventilation and then according to “minimized inspiratory power” with (adaptive ventilation mode 2 (AVM2), or group II “AVM2- LTV”, ventilated with both modes in the reversed order. After 6 hours, patients previously ventilated with LTV were switched to AVM2 and vice versa."
LTV will based on the current standard of lung protective volume control ventilation at 6ml/kg while the AVM2 will dynamic and will be based to minimize inspiratory power
Duration will be 6 hours for each mode
This will be done by the bed side ICU consultant
Adherence will be monitored by the ventilator and medical records

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Comparator
Usual care, with a tidal volume-based approach with clinically selected PEEP (both groups) and tidal volume in the control group (LTV) will be maintained unchanged throughout the whole study period using a modified version of the ARDSnet protocol as used in the LOVS study
Reference
Meade MO, Cook DJ, Guyatt GH et al (2008) Ventilation strategy using low tidal volumes, recruitment maneuvers, and high positive end-expiratory pressure for acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. JAMA 299:637–645

Control group

Active

Outcomes

Primary outcome [1]

Driving pressure as measured by ventilator readings

Timepoint [1]

6 hours post-commencement of each cycle of either LTV or AVM2 ventilation

Secondary outcome [1]

Delivered tidal volume as measured by the ventilator

Timepoint [1]

6 hours post-commencement of each cycle of either LTV or AVM2 ventilation,

Secondary outcome [2]

Mechanical power as measured by the ventilator

Timepoint [2]

6 hours post-commencement of each cycle of either LTV or AVM2 ventilation,

Secondary outcome [3]

Pa02/ Fio2 ratio-ABG

Timepoint [3]

ABG -Every 2 hours for 6 hours (3 readings) post-commencement of each cycle of either LTV or AVM2 ventilation,

Secondary outcome [4]

Paco2 -ABG

Timepoint [4]

ABG- Every 2 hours for 6 hours (3 readings) post-commencement of each cycle of either LTV or AVM2 ventilation

Secondary outcome [5]

pH-ABG

Timepoint [5]

ABG - Every 2 hours for 6 hours (3 readings) post-commencement of each cycle of either LTV or AVM2 ventilation

Secondary outcome [6]

Dead space as measured by the ventilator

Timepoint [6]

6 hours post-commencement of each cycle of either LTV or AVM2 ventilation,

Secondary outcome [7]

Blood pressure as measured by the arterial line

Timepoint [7]

6 hours post-commencement of each cycle of either LTV or AVM2 ventilation

Secondary outcome [8]

Heart rate as measured by the ECG leads

Timepoint [8]

6 hours post-commencement of each cycle of either LTV or AVM2 ventilation

Secondary outcome [9]

Vasopressor dosage from the clinical details

Timepoint [9]

6 hours post-commencement of each cycle of either LTV or AVM2 ventilation

Eligibility

Key inclusion criteria

who were greater than equal to 18 years of age, intubated, and within 48h of a diagnosis of moderate/severe ARDS (PaO2/FiO2 less than or equal to 200 mmHg, PEEP more than or equal to 5 cm H2O, bilateral opacities on chest X-ray and respiratory failure not fully explained by cardiac failure or fluid overload)

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

patients with active bronchospasm or a history of significant chronic obstructive pulmonary disease or asthma, lack of consent (treating physician or next of kin), inevitable and imminent death, pregnancy, those receiving ECMO, or involvement in other prospective clinical studies.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

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

Sealed envelopes

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

Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Standard statistical measures to compare parametric and non parametric data will be used

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/04/2022

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

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Flinders Medical Centre ICU

Address [1]

Flinders Drive, Bedford Park SA 5042

Country [1]

Australia

Primary sponsor type

Hospital

Name

Flinders Medical Centre ICU

Address

Flinders Drive, Bedford Park SA 5042

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Southern Adelaide Clinical Human Research Ethics Committee.

Ethics committee address [1]

 Flinders Drive, Bedford Park SA 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/02/2022

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

AIM
The primary aim of this study is to determine whether use of adaptive ventilation mode (AVM2) which uses an automated mechanical power algorithm leads to a decrease in driving pressure in patients with moderate to severe ARDS. 

HYPOTHESIS 
We hypothesized that, when compared to “traditional” Lung protective mechanical ventilation based on low tidal volume ventilation, ventilator settings selected by AVM2 will have a lower driving pressure 

DESIGN
A single centre feasibility / physiological / proof of concept study in 20 ARDS patients within 24 hours of intubation (moderate to severe ARDS).
Study design will be a prospective randomized cross-over study in 20 critically ill patients on controlled mechanical ventilation- with randomized 6 hours of LTV and 6 hours of AVM2. 

Study period
2 years
Setting
Single Centre study conducted in the Intensive care unit (ICU) at Flinders Medical Centre, Australia

Population
Inclusion: who are 'greater than and equal to' 18 years of age, intubated, and within 48h of a diagnosis of moderate/severe ARDS (PaO2/FiO2 <= 200 mmHg, PEEP >= 5 cm H2O, bilateral opacities on chest X-ray and respiratory failure not fully explained by cardiac failure or fluid overload)
Exclusion: patients with active bronchospasm or a history of significant chronic obstructive pulmonary disease or asthma, lack of consent (treating physician or next of kin), inevitable and imminent death, pregnancy, those receiving ECMO, or involvement in other prospective clinical studies.

Intervention
AVM2 which uses an automated mechanical power algorithm.

Comparator
Usual care, with a tidal volume-based approach as per the ARDSnet protocol
Sample size
20 patient – feasibility study 

STUDY ENDPOINTS
Outcomes
The Primary outcome is driving pressure. 
Other secondary outcomes will include delivered tidal volume, mechanical power, PaO2/FiO2 ratio, PaCO2, pH, lung dead space and patients hemodynamic (hemodynamic data on MAP and HR were averaged during the last 5 min of each hour of the 6-h period)

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Shailesh Bihari

Address

Dept of ICU, Flinders Medical Centre, Flinders Drive, Bedford Park SA 5042

Country

Australia

Phone

+61 08 82047288

Fax

biharishailesh@gmail.com

Contact person for public queries

Name

Shailesh Bihari

Address

Dept of ICU, Flinders Medical Centre, Flinders Drive, Bedford Park SA 5042

Country

Australia

Phone

+61 08 82047288

Fax

biharishailesh@gmail.com

Contact person for scientific queries

Name

Shailesh Bihari

Address

Dept of ICU, Flinders Medical Centre, Flinders Drive, Bedford Park SA 5042

Country

Australia

Phone

+61 08 82047288

Fax

biharishailesh@gmail.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 deidentified clinical data

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

After publication of the study with no end date

Available to whom?

All interested researchers

Available for what types of analyses?

Exploratory or meta analysis

How or where can data be obtained?

Direct contact with the investigator - contact
Shailesh Bihari
Email - biharishailesh@gmail.com ; Shailesh.Bihari@sa.gov.au; biha0002@flinders.edu.au
Phone - +61 8 82047288
Mail - Dept of ICU, Flinders Medical Centre, Flinders Drive, Bedford Park South Australia 5042

What supporting documents are/will be available?

No Supporting Document Provided

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.

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