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Trial registered on ANZCTR


Registration number
ACTRN12613001193763
Ethics application status
Approved
Date submitted
28/10/2013
Date registered
30/10/2013
Date last updated
30/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective in-group comparison of the efficacy and safety of fully closed-loop control ventilation (Intellivent-ASV (Registered Trademark) with conventional adaptive support ventilation (ASV) and synchronized intermittent mandatory ventilation (SIMV) modes.
Scientific title
A prospective in-group comparison of the efficacy and safety of fully closed-loop control ventilation (Intellivent-ASV (Registered Trademark)) with conventional adaptive support ventilation (ASV) and synchronized intermittent mandatory ventilation (SIMV) modes in adult critically ill patients in the medical intensive care unit.
Secondary ID [1] 283471 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically ill patients receiving mechanical ventilation 290385 0
Condition category
Condition code
Respiratory 290778 290778 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Materials and Methods:
The study will take place in the 9-bed Medical ICU (MICU) at the Hadassah-Hebrew University Medical Center, a 750-bed academic tertiary referral center. The MICU admits critically ill, non-surgical cases with acute respiratory, infectious, neurological, haematological-oncological, renal, metabolic and other general medical problems.
All patients admitted to our MICU and who will be ventilated for at least 24 hours prior to recruitment will be eligible for inclusion. Patients included will also need to have stable hemodynamic and respiratory parameters over the previous 12 hours. We will exclude patients due for extubation on the same day, patients with unstable hemodynamic parameters (labile blood pressure or pulse rate or escalating vasopressor or inotrope requirements), those requiring mandatory ventilation (such as pressure controlled ventilation) or who are receiving inhaled nitric oxide. Pregnant women and minors (age less than 18 years) will also be excluded.
The study was reviewed and approved by the Hadassah Hebrew University Hospital Institutional Review Board.

Study design and parameters recorded:
1. Participants will all be initially ventilated for at least two hours on ASV, the standard ventilation mode in our Medical ICU. The usual initial setting is 100% minute ventilation using the patient ideal body weight, PEEP within the range of 2-12 cmH2O PEEP and the lowest FiO2 allowing adequate oxygenation (SaO2 greater than 93% or a PaO2 greater than 70 mmHg) in the range of FiO2 0.35 - 0.5. At the end of this 2 hour period, baseline parameters and arterial blood gases will be obtained. These include blood pressure (BP), heart rate (HR), FiO2, PEEP, inspiratory pressure received, compliance, resistance, peak inspiratory pressure , respiratory rate- (total breaths per minute and spontaneous breaths per minute) , spontaneous minute volume, expiratory tidal volume and actual minute volume.
2. The ventilation mode will then be changed to Intellivent-ASV (Registered trademark) for a period of two hours, after which the same parameters will be recorded.
3. The patients will subsequently be returned to the standard (baseline) mode of ventilation (ASV) for two hours, followed by a change to SIMV mode for a period of two hours, after which the same, previously described, parameters will be obtained. SIMV settings will be determined by the treating intensivist according to individual preference and patient condition, based on: tidal volume of 6-10 ml/kg, respiratory rate of 10-18 breaths per minute, PEEP of 2-12 cmH2O and pressure support of 10-20 cmH2O.
The doses of sedatives administered to the patients will not altered throughout the study period.
Data Analysis
The results will be presented as mean plus standard deviation or range. Groups will be compared using analysis of variance (ANOVA) to detect if "between-group" variation is greater than "within-group" variation. In addition, the Student's T-test will be used to compare matched groups. A p value of less than 0.05 will be considered significant.
Intervention code [1] 288180 0
Treatment: Devices
Intervention code [2] 288181 0
Treatment: Other
Comparator / control treatment
New mode of ventilation (Intellivent-ASV) will be compared to two established modes of ventilation - ASV and SIMV
Control group
Active

Outcomes
Primary outcome [1] 290775 0
To determine the efficacy and safety of the new mode of ventilation (Intellivent -ASV) with two established modes of ventilation (ASV and SIMV) by:
- ensuring that haemodynamic and respiratory parameters when using the Intellivent mode are not worse than those achieved in the standard modes (ASV and SIMV).
These comparisons will be done by ANOVA and Student's t tests - to determine if the between group variations are gearter than the within-group variations.
Timepoint [1] 290775 0
At the end of the study intervention - 6 hours after commencement of study and immediately at the end of the study
Secondary outcome [1] 305262 0
Nil
Timepoint [1] 305262 0
Nil

Eligibility
Key inclusion criteria
All patients admitted to our MICU and who will be ventilated for at least 24 hours prior to recruitment are eligible for inclusion. Patients included will also be required to have had stable hemodynamic and respiratory parameters over the previous 12 hours.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We will exclude patients due for extubation on the same day, patients with unstable hemodynamic parameters (labile blood pressure or pulse rate or escalating vasopressor or inotrope requirements), those requiring mandatory ventilation (such as pressure controlled ventilation) or who are receiving inhaled nitric oxide. Pregnant women and minors (age less than 18 years) will also be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All ventilated patients in the medical ICU will be considered as long as they have stable respiratory and haemodynamic parameters and are not due for imminent extubation.
The three ventilation modalities as described above will then be allocated for two hour periods in the same order in a non-blinded fashion - ASV, then Intellivent and then SIMV
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non-randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Single cohort of twenty patients who cross over between three modalities of ventilation.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
ANOVA to detect between group differences which are greater than within-group differences.

The Student's T-test will be used to compare matched groups.

A p value of less than 0.05 will be considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/02/2013
Actual
28/02/2013
Date of last participant enrolment
Anticipated
31/07/2013
Actual
31/07/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 5540 0
Israel
State/province [1] 5540 0

Funding & Sponsors
Funding source category [1] 288178 0
Self funded/Unfunded
Name [1] 288178 0
Country [1] 288178 0
Israel
Primary sponsor type
Individual
Name
Dr PV van Heerden
Address
Medical ICU
Hadassah University Hospital
PO Box 12000
Jerusalem 91120
Country
Israel
Secondary sponsor category [1] 286901 0
None
Name [1] 286901 0
None
Address [1] 286901 0
None
Country [1] 286901 0
Israel

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290091 0
Hadassah University Hospital Institutional Ethics Review Committee
Ethics committee address [1] 290091 0
Ethics committee country [1] 290091 0
Israel
Date submitted for ethics approval [1] 290091 0
25/01/2013
Approval date [1] 290091 0
14/02/2013
Ethics approval number [1] 290091 0
0041-13-HMO

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43914 0
Prof Peter Vernon van Heerden
Address 43914 0
Medical ICU
Hadassah University Hospital
PO Box 12000
Jerusalem 91120
Country 43914 0
Israel
Phone 43914 0
+972 505172864
Fax 43914 0
Email 43914 0
vernon@hadassah.org.il
Contact person for public queries
Name 43915 0
Peter Vernon van Heerden
Address 43915 0
Medical ICU
Hadassah University Hospital
PO Box 12000
Jerusalem 91120
Country 43915 0
Israel
Phone 43915 0
+972 505172864
Fax 43915 0
Email 43915 0
vernon@hadassah.org.il
Contact person for scientific queries
Name 43916 0
Peter Vernon van Heerden
Address 43916 0
Medical ICU
Hadassah University Hospital
PO Box 12000
Jerusalem 91120
Country 43916 0
Israel
Phone 43916 0
+972 505172864
Fax 43916 0
Email 43916 0
vernon@hadassah.org.il

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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