Hypovolemia, Hypervolemia
Conditions
Keywords
fluid responsiveness, haemodynamical monitoring, ClearSight
Brief summary
The decision to give fluids perioperatively could be based on methods used to identify preload responsiveness, either invasive or noninvasive estimates of stroke volume variation during mechanical ventilation. This study compares fluid management using continuous noninvasive cardiac output measurement with standard perioperative fluid management.
Detailed description
The aim of the study is to optimise fluid managemet and to reduce perioperative risks during spinal procedures in prone position. Adequate perioperative management guided by hemodynamic monitoring can help to reduce the risk of complications and thus potentially improve outcomes.
Interventions
PROCEDUREStandard care group
Patient will receive 2 ml/kg/hour of crystalloids (Ringerfundin BBraun) intraoperatively. Fluid boluses will be used according to anesthesiologists decision (timing and amount of fluids). In case of drop of mean arterial pressure (MAP) below 65 mmHg norepinephrine will be started (with initial bolus of 5 - 10 ug).
PROCEDURENoninvasive monitoring group
Patient will receive 2 ml/kg/hour of crystalloids (Ringerfundin BBraun) intraoperatively. In case of hypotension (defined as a mean arterial pressure below 65 mmHg), the intervention will be led according to a protocol based on cardiac index, systemic vascular resitance and stroke volume variation (SVV) values (ClearSight, Edwards).
Sponsors
University Hospital Hradec Kralove
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Glasgow Coma scale 15 * ASA Physical Status Classification System I-III * planed spinal surgery to 3 hours * postoperative awakening * sinus rhythm
Exclusion criteria
* NYHA III, IV * BMI over 40 in females and over 35 in men * awake operation * postoperative artificial ventilation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative fluid balance | 5 hours | the difference between fluid intake and output and losses during surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| level of creatinine | 24 hours | plasma level of creatinine measured on the first postoperative day |
| mean dose of norepinephrine | 5 hours | mean dose of norepinephrine wil be calculated as total intraoperative norepinephrine dose devided by the lenght of surgery |
| pooperative lung dysfunction | 24 hours | postoperative lung dysfunction defined as SpO2 value less than 92% or oxygen therapy for more than 6 hours postoperatively |
| the length of postoperative stay | till 2 months after surgery | the length of postoperative stay in hospital |
Countries
Czechia
Outcome results
None listed