Tidal Volume Challenge During Prone position for Assessing Fluid Responsiveness. A Interventional Prospective Trial

• Register: ANZCTR
• Last refreshed on: 7 January 2019
• Main ID: ACTRN12618000682246
• Date of registration: 26/04/2018
• Prospective Registration: No
• Primary sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
• 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.
• Date of first enrolment: 15/01/2018
• Target sample size: 38
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12618000682246.aspx
• Study type: Interventional
• Study design: Purpose: Diagnosis; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;

Countries of recruitment

Italy

Contacts

• Name: Dr Antonio Messina

• Name: Dr Antonio Messina

Key inclusion & exclusion criteria

Inclusion criteria: Elective neurosurgical prone patients requiring invasive arterial monitoring
Need of fluid challenge as required by the attending anesthetist
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.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Surgery - Other surgery

Anaesthesiology - Other anaesthesiology

Hemodynamic Instability;Hypovolemia;
Hemodynamic Instability
Hypovolemia

Intervention(s)

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).

Primary Outcome(s)

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[Immediately following fluid challenge infusion]

Secondary Outcome(s)

Change in pulse pressure measured by means of MOSTCARE system after fluid challenge infusion[after fluid challenge infusion at 10 minutes]

Secondary ID(s)

None

Source(s) of Monetary Support

Azienda Ospedaliero Universitaria Maggiore della Carita

Ethics review

Status: Approved
Approval date:
Contact:

Comitato Etico Interaziendale Novara

Results

• Results available: Yes
• Date Posted: 12/12/2018
• Date Completed: 31/07/2018