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

Tidal Volume Challenge During Neurosurgery for Assessing Fluid Responsiveness. A Interventional Prospective Trial of Patients Scheduled for Prone Surgery.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000682246
Enrollment
40
Registered
2018-04-26
Start date
2018-01-15
Completion date
2018-07-31
Last updated
2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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) TV

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).

Sponsors

Azienda Ospedaliero Universitaria Maggiore della Carita
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026