Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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] 306059 0
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) 324701 0
Condition category
Condition code
Respiratory 322153 322153 0 0
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] 322463 0
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] 329920 0
Driving pressure as measured by ventilator readings
Timepoint [1] 329920 0
6 hours post-commencement of each cycle of either LTV or AVM2 ventilation
Secondary outcome [1] 404982 0
Delivered tidal volume as measured by the ventilator
Timepoint [1] 404982 0
6 hours post-commencement of each cycle of either LTV or AVM2 ventilation,
Secondary outcome [2] 404983 0
Mechanical power as measured by the ventilator
Timepoint [2] 404983 0
6 hours post-commencement of each cycle of either LTV or AVM2 ventilation,
Secondary outcome [3] 404984 0
Pa02/ Fio2 ratio-ABG
Timepoint [3] 404984 0
ABG -Every 2 hours for 6 hours (3 readings) post-commencement of each cycle of either LTV or AVM2 ventilation,
Secondary outcome [4] 404985 0
Paco2 -ABG
Timepoint [4] 404985 0
ABG- Every 2 hours for 6 hours (3 readings) post-commencement of each cycle of either LTV or AVM2 ventilation
Secondary outcome [5] 404986 0
pH-ABG
Timepoint [5] 404986 0
ABG - Every 2 hours for 6 hours (3 readings) post-commencement of each cycle of either LTV or AVM2 ventilation
Secondary outcome [6] 404987 0
Dead space as measured by the ventilator
Timepoint [6] 404987 0
6 hours post-commencement of each cycle of either LTV or AVM2 ventilation,
Secondary outcome [7] 404988 0
Blood pressure as measured by the arterial line
Timepoint [7] 404988 0
6 hours post-commencement of each cycle of either LTV or AVM2 ventilation
Secondary outcome [8] 404989 0
Heart rate as measured by the ECG leads
Timepoint [8] 404989 0
6 hours post-commencement of each cycle of either LTV or AVM2 ventilation
Secondary outcome [9] 404990 0
Vasopressor dosage from the clinical details
Timepoint [9] 404990 0
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?
No
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
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 21341 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 36232 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 310381 0
Hospital
Name [1] 310381 0
Flinders Medical Centre ICU
Country [1] 310381 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre ICU
Address
Flinders Drive, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 311544 0
None
Name [1] 311544 0
Address [1] 311544 0
Country [1] 311544 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 310033 0
Southern Adelaide Clinical Human Research Ethics Committee.
Ethics committee address [1] 310033 0
Flinders Drive, Bedford Park SA 5042
Ethics committee country [1] 310033 0
Australia
Date submitted for ethics approval [1] 310033 0
01/02/2022
Approval date [1] 310033 0
Ethics approval number [1] 310033 0

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 116258 0
A/Prof Shailesh Bihari
Address 116258 0
Dept of ICU, Flinders Medical Centre, Flinders Drive, Bedford Park SA 5042
Country 116258 0
Australia
Phone 116258 0
+61 08 82047288
Fax 116258 0
Email 116258 0
biharishailesh@gmail.com
Contact person for public queries
Name 116259 0
A/Prof Shailesh Bihari
Address 116259 0
Dept of ICU, Flinders Medical Centre, Flinders Drive, Bedford Park SA 5042
Country 116259 0
Australia
Phone 116259 0
+61 08 82047288
Fax 116259 0
Email 116259 0
biharishailesh@gmail.com
Contact person for scientific queries
Name 116260 0
A/Prof Shailesh Bihari
Address 116260 0
Dept of ICU, Flinders Medical Centre, Flinders Drive, Bedford Park SA 5042
Country 116260 0
Australia
Phone 116260 0
+61 08 82047288
Fax 116260 0
Email 116260 0
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.