Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000351213
Ethics application status
Approved
Date submitted
14/11/2017
Date registered
8/03/2018
Date last updated
19/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tidal Volume Challenge During Neurosurgery 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 Supine Surgery
Secondary ID [1] 293354 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tidal Volume Challenge 305469 0
Hypovolemia
Hemodynamic Instability
 305470 0
Anesthesia
Neurosurgery 305471 0
fluid responsiveness
tidal volume challenge
fluid responsiveness 305472 0
stroke volume variation
pulse pressure variation 305475 0
Condition category
Condition code
Surgery 304730 304730 0 0
Other surgery
Cardiovascular 305570 305570 0 0
Normal development and function of the cardiovascular system

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 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] 299610 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303941 0
The receiver operating characteristic curve of SVV variation after TVC application
A patient will be consider responder for a cardiac index increase of at least 15%.
Timepoint [1] 303941 0
Immediately following fluid challenge infusion
Primary outcome [2] 304693 0
The receiver operating characteristic curve of PPV variation after TVC application
A patient will be consider responder for a cardiac index increase of at least 15%.
Timepoint [2] 304693 0
Immediately following fluid challenge infusion
Secondary outcome [1] 340520 0
To compare the area under the Receiver operating characteristic (ROC) curve of TVC and EEO
Timepoint [1] 340520 0
Immediately following fluid challenge infusion

Eligibility
Key inclusion criteria
Elective neurosurgical patients requiring invasive arterial monitoring
Need of fluid challenge as required by the attending anesthetist
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any cardiac arrhythmia
Consent denied
Instable intracranial pressure or emergency surgical treatment
Spinal shock

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
20
Final
Recruitment outside Australia
Country [1] 9355 0
Italy
State/province [1] 9355 0

Funding & Sponsors
Funding source category [1] 297979 0
University
Name [1] 297979 0
Azienda Ospedaliero Universitaria Maggiore della Carita
Country [1] 297979 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] 297047 0
None
Name [1] 297047 0
Address [1] 297047 0
Country [1] 297047 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299020 0
Comitato Etico Interaziendale Novara
Ethics committee address [1] 299020 0
Ethics committee country [1] 299020 0
Italy
Date submitted for ethics approval [1] 299020 0
30/10/2017
Approval date [1] 299020 0
15/12/2017
Ethics approval number [1] 299020 0

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

Contacts
Principal investigator
Name 79010 0
Dr ANTONIO MESSINA
Address 79010 0
AOU MAGGIORE DELLA CARITA' - INTENSIVE CARE UNIT; Corso Giuseppe Mazzini 18; Novara, Italy, 28100
Country 79010 0
Italy
Phone 79010 0
+3903213733380
Fax 79010 0
Email 79010 0
[email protected]
Contact person for public queries
Name 79011 0
ANTONIO MESSINA
Address 79011 0
AOU MAGGIORE DELLA CARITA' - INTENSIVE CARE UNIT; Corso Giuseppe Mazzini 18; Novara, Italy, 28100
Country 79011 0
Italy
Phone 79011 0
+3903213733380
Fax 79011 0
Email 79011 0
[email protected]
Contact person for scientific queries
Name 79012 0
ANTONIO MESSINA
Address 79012 0
AOU MAGGIORE DELLA CARITA' - INTENSIVE CARE UNIT; Corso Giuseppe Mazzini 18; Novara, Italy, 28100
Country 79012 0
Italy
Phone 79012 0
+3903213733380
Fax 79012 0
Email 79012 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTidal volume challenge to predict fluid responsiveness in the operating room: An observational study.2019https://dx.doi.org/10.1097/EJA.0000000000000998
N.B. These documents automatically identified may not have been verified by the study sponsor.