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Trial registered on ANZCTR


Registration number
ACTRN12615001232527
Ethics application status
Approved
Date submitted
12/09/2015
Date registered
10/11/2015
Date last updated
11/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Application of incremental intra-thoracic positive pressure through mechanical ventilation maneuvers: a new tool to predict fluid-responsiveness in patients undergoing pressure support ventilation?
Scientific title
The prediction of fluid-responsiveness in critically ill patients undergoing pressure support ventilation as assessed by the application of incremental positive intra-thoracic pressures
Secondary ID [1] 287462 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 296185 0
Hemodynamic status 296561 0
Fluid responsiveness 296562 0
Condition category
Condition code
Cardiovascular 296464 296464 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be monitored with a monitor for hemodynamic assesment (Most Care, Vytech Health, Padova, Italy), which uses a Pressure Recording Analytical Method (PRAM).
PRAM is a method designed for arterial pressure-derived continuous Cardiac Output and it is the only methodology that does not need any starting calibration, central venous catheterization, or any adjustments based on experimental data. As a consequence, PRAM needs only an arterial line (radial, brachial, femoral) for working.
When the patient has been monitored with Most Care device, baseline data will be acquired for 2 minutes. Afterwards, incremental values (15, 25 and 35 cmH2O) of positive airway pressure will be applied for a short period of 4 seconds in a random order. Between each single trial of incremental pressures, a return to baseline conditions will be guarantee for 3 minutes, to avoid carry-over effects.
In the end, a fluid challenge of 500 ml of normal saline will be infused in 5 minutes and the hemodynamic response will be evaluted to define if the patient is fluid responsive or not (i.e. if the cardiac index incremented of 15% at least, or not).
Furthermore, in the first 10 consecutive patients, we will insert a catheter able to measure the esophageal pressure to properly assess the incidence of inspiratory effort during each single trial of incremental pressures (i.e. 15, 25 and 35 cmH2O randomly applied for a short period of 4 seconds).
Intervention code [1] 292837 0
Treatment: Other
Comparator / control treatment
Every patient will be a self control. In fact, patients will be defined as fluid-responsive or not according to the modifications of the Cardiac Index after the fluid challenge. Therefore, the data obtained during the positive airway pressure applications will be classified and analyzed accordingly.
Control group
Active

Outcomes
Primary outcome [1] 296088 0
To understand if the application of incremental positive airway pressure can predict the fluid responsiveness (as defined by an incremental of the cardiac index > 15%) in patients undergoing partial support mechanical ventilation.
Timepoint [1] 296088 0
Record and analysis of the Pulse Pressure Variation values at each protocol trial (baselines; 15,25 and 35 cmH2O positive airway pressure tests; after fluid challenge, to define if the patient is fluid responsive or not).
Secondary outcome [1] 317463 0
None
Timepoint [1] 317463 0
None

Eligibility
Key inclusion criteria
All patients > 18 years/old undergoing invasive mechanical ventilation in Pressure Support mode (se with a positive end-expiratory pressure between 4 and 6 cmH2O and a Pressure Support betweeen 8 and 12 cmH2O), with a clinical need for fluid infusion, i.e. systolic arterial blood pressure < 90 mmHg or 50 mmHg reduction of values in patients with chronic hypertension, oliguria as defined by a diuresis < 0.5 ml/kg/h, need for inotropes, lactate > 2 mmol/L.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if meeting one or more off the following criteria: 1) cardiac arrhythmia; 2) atrial fibrillation or flutter; 3) patients undergoing any form of renal replacement therapy; 4) valvular defects of moderate to severe grade; 5) history of congestive cardiac failure; 6) previous or presence of pneumothorax or emphysema; 7) patients with Chronic Obstructive Pulmonary Disease (COPD); 8) patients with kyphoscoliosis; 9) use of expiratory muscles and 10) arterial partial pressure to inspired fraction of oxygen (PaO2/FiO2) ratio < 200.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Everyday physician responsible for patients recruitment will screen all the patients in the Intensive Care Unit, to check those meeting inclusion criteria.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use a computer-generated randomization sequence, which will be generated by an independent statistician who is not otherwise involved in the trial. The envelopes will be kept in the head nurses’ office. The nurses who open the envelopes will be those on shift and will be totally independent from the enrollment process. They will communicate the random sequence of the application of the incremental positive pressures to the physician responsible for the patient enrollment.
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
Basing on the amount of patients enrolled in previous study to test the efficacy of a fluid responsiveness test, we believe that a total of 40 patients could be sufficient to define if Pulse Pressure Variation could be a valid indicator for fluid responsiveness in patients undergoing incremental applied values of positive airway pressure. However, a precise sample size computation is not possible, since to date no data are present in the literature regarding the investigated test.
The data of the two resulting groups of patients (i.e. responsive or not) will be compared with a Mann-Whitney U-test or a Student t-test, according to the normal distribution of data. p values < 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/12/2015
Actual
4/05/2014
Date of last participant enrolment
Anticipated
Actual
31/01/2016
Date of last data collection
Anticipated
Actual
31/01/2016
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 7162 0
Italy
State/province [1] 7162 0
Novara

Funding & Sponsors
Funding source category [1] 292033 0
Self funded/Unfunded
Name [1] 292033 0
Federico Longhini, MD
Country [1] 292033 0
Italy
Primary sponsor type
Individual
Name
Federico Longhini MD
Address
Intensive Care Unit, ASL VC - Azienda Sanitaria Locale di Vercelli, C.so Mario Abbiate n. 21 - 13100 - Vercelli
Country
Italy
Secondary sponsor category [1] 290703 0
None
Name [1] 290703 0
Address [1] 290703 0
Country [1] 290703 0
Other collaborator category [1] 278620 0
Individual
Name [1] 278620 0
Antonio Messina, MD
Address [1] 278620 0
Corso Mazzini 19, Intensive Care Unit, "Maggiore della Carita" Universitary Hospital, 28100, Novara
Country [1] 278620 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293519 0
Comitato Etico Interaziendale Novara
Ethics committee address [1] 293519 0
Corso Mazzini 18, 28100, Novara
Ethics committee country [1] 293519 0
Italy
Date submitted for ethics approval [1] 293519 0
06/03/2013
Approval date [1] 293519 0
07/06/2013
Ethics approval number [1] 293519 0
CE 43/13

Summary
Brief summary
The proper infusion of fluids is a challenge in critically ill patients undergoing partial support ventilation. The clinically used indexes for fluid-responsiveness are affected by several limitations. In the present study we hypothesized and aim to verify if the application of incremental values of positive airway pressures are able to predict the fluid responsiveness in patients with clinical signs of fluid repletion and undergoing Pressure Support Ventilation.
Trial website
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 60286 0
Dr Antonio Messina
Address 60286 0
Intensive Care Unit, "Maggiore dellaa Carita" Hospital, Corso Mazzini 18, 28100, Novara
Country 60286 0
Italy
Phone 60286 0
+3903213733380
Fax 60286 0
Email 60286 0
[email protected]
Contact person for public queries
Name 60287 0
Federico Longhini
Address 60287 0
Intensive Care Unit, ASL VC - Azienda Sanitaria Locale di Vercelli, C.so Mario Abbiate n. 21 - 13100 - Vercelli
Country 60287 0
Italy
Phone 60287 0
+393475395967
Fax 60287 0
Email 60287 0
[email protected]
Contact person for scientific queries
Name 60288 0
Federico Longhini
Address 60288 0
Intensive Care Unit, ASL VC - Azienda Sanitaria Locale di Vercelli, C.so Mario Abbiate n. 21 - 13100 - Vercelli
Country 60288 0
Italy
Phone 60288 0
+393475395967
Fax 60288 0
Email 60288 0
[email protected]

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