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Trial registered on ANZCTR


Registration number
ACTRN12618000682246
Ethics application status
Approved
Date submitted
12/03/2018
Date registered
26/04/2018
Date last updated
12/12/2018
Date data sharing statement initially provided
12/12/2018
Date results information initially provided
12/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tidal Volume Challenge During Prone position for Assessing Fluid Responsiveness. A Interventional Prospective Trial
Scientific title
Tidal Volume Challenge During Neurosurgery for Assessing Fluid Responsiveness. A Interventional Prospective Trial of Patients Scheduled for Prone Surgery.
Secondary ID [1] 294316 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemodynamic Instability 307029 0
Hypovolemia 307031 0
Condition category
Condition code
Surgery 306131 306131 0 0
Other surgery
Anaesthesiology 306132 306132 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The TVC has been proposed as novel hemodynamic test to assess fluid responsiveness in ICU patients. TVC consists in the transient increase of Tidal Volume from 6ml/kg to 8ml/kg for 1 minute. The TVC-related changes of stroke volume variation (SVV) and pulse pressure variation (PPV) are highly predictive of fluid responsiveness. The aim of the present study is to assess TVC reliability in a population of neurosurgical patients scheduled for prone or supine surgery.
Brief description of TVC:
1) TVC is a transient increase in the Tidal Volume used to ventilate the patient from 6 to 8 ml/kg of predicted body weight
2) The duration is 1 minute
3) The attending anesthetist will modify the setting of the ventilation in operating room
4) The decision of administer fluids because of transient hypotension (defined as a reduction of >20% of systolic blood pressure recorded at the beginning of the operation) is the indication to perform first the TVC
5) Only the first fluid challenge will be recorded. The frequency of administration will be decided by the attending anesthetist according to the occurrence of hemodynamic instability, for the entire duration of the operation.

The end-expiratory occlusion test is a hemodynamic test aiming to assess fluid responsiveness by means of a interruption of mechanical ventilation. In order to compare TVC with EEO, the EEO will be also performed in all the patients at predefined time points (before and after TVC, when the patient is ventilated with 6ml/kg and 8 lm/kg respectively).
Intervention code [1] 300621 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305149 0
Number of participants who are considered 'Responders'; with a responder defined as an increase of at least 10% in stroke volume index measured by means of MOSTCARE system
Timepoint [1] 305149 0
Immediately following fluid challenge infusion
Secondary outcome [1] 345519 0
Change in pulse pressure measured by means of MOSTCARE system after fluid challenge infusion
Timepoint [1] 345519 0
after fluid challenge infusion at 10 minutes

Eligibility
Key inclusion criteria
Elective neurosurgical prone patients requiring invasive arterial monitoring
Need of fluid challenge as required by the attending anesthetist
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria are 1) any cardiac arrhythmia; 2) reduced left (reduced ejection fraction < 40%) or right (systolic peak velocity of tricuspid annular motion < 0.16 m/s) ventricular ejection fraction; 3) unstable intracranial pressure; 4); Body Mass Index (BMI) > 40; 5) use of vasopressors or inotropes before TVC and EEO applications; 6) chronic lung diseases.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Single group
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
A diagnostic test is considered to have good accuracy when its area under the ROC curve is at least 0.75 (Ray P, Le Manach Y, Riou B, Houle TT. Statistical evaluation of a biomarker. Anesthesiology. 2010;112:1023–40. 16.)
Thirty eight patients are necessary to show an area under the receiver operating characteristics (ROC) curve greater than or equal to 0.75 (type I error of 5% and type II error of 20%).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9680 0
Italy
State/province [1] 9680 0
Piedmont - Novara

Funding & Sponsors
Funding source category [1] 298962 0
University
Name [1] 298962 0
Azienda Ospedaliero Universitaria Maggiore della Carita
Address [1] 298962 0
Corso Mazzini n. 18 28100 Novara Italy
Country [1] 298962 0
Italy
Primary sponsor type
University
Name
Azienda Ospedaliero Universitaria Maggiore della Carita
Address
Corso Mazzini n. 18 28100 Novara Italy
Country
Italy
Secondary sponsor category [1] 298178 0
None
Name [1] 298178 0
Address [1] 298178 0
Country [1] 298178 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299896 0
Comitato Etico Interaziendale Novara
Ethics committee address [1] 299896 0
Corso Mazzini, 18 - 28100 Novara - Italy
Ethics committee country [1] 299896 0
Date submitted for ethics approval [1] 299896 0
10/10/2017
Approval date [1] 299896 0
15/12/2017
Ethics approval number [1] 299896 0

Summary
Brief summary
TVC has never been tested in surgical populations. We aim to perform a clinical study to assess TVC reliability in prone and supine surgical patients.
The TVC has been proposed as novel hemodynamic test to assess fluid responsiveness in ICU patients. TVC consists in the transient increase of Tidal Volume from 6ml/kg to 8ml/kg for 1 minute. The TVC-related changes of stroke volume variation (SVV) and pulse pressure variation (PPV) are highly predictive of fluid responsiveness. The aim of the present study is to assess TVC reliability in a population of neurosurgical patients scheduled for prone or supine surgery. The secondary aim is to compare TVC with another hemodynamic test, already successfully tested in operating room: the end-expiratory occlusion test.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81906 0
Dr Antonio Messina
Address 81906 0
AOU MAGGIORE DELLA CARITA' - INTENSIVE CARE UNIT; Corso Giuseppe Mazzini 18; Novara, Italy, 28100
Country 81906 0
Italy
Phone 81906 0
+3903213733380
Fax 81906 0
Email 81906 0
mess81rc@gmail.com
Contact person for public queries
Name 81907 0
Dr Antonio Messina
Address 81907 0
AOU MAGGIORE DELLA CARITA' - INTENSIVE CARE UNIT; Corso Giuseppe Mazzini 18; Novara, Italy, 28100
Country 81907 0
Italy
Phone 81907 0
+3903213733380
Fax 81907 0
Email 81907 0
mess81rc@gmail.com
Contact person for scientific queries
Name 81908 0
Dr Antonio Messina
Address 81908 0
AOU MAGGIORE DELLA CARITA' - INTENSIVE CARE UNIT; Corso Giuseppe Mazzini 18; Novara, Italy, 28100
Country 81908 0
Italy
Phone 81908 0
+3903213733380
Fax 81908 0
Email 81908 0
mess81rc@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Ethical approval
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary