Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care group | Active Comparator | Fluid management will be done according standard care |
|
| Noninvasive monitoring group | Experimental | Fluid management will be provided using noninvasive hemodynamical monitor ClearSight (Edwards) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard care group | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| intraoperative fluid balance | the difference between fluid intake and output and losses during surgery | 5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| mean dose of norepinephrine | mean dose of norepinephrine wil be calculated as total intraoperative norepinephrine dose devided by the lenght of surgery | 5 hours |
| level of creatinine | plasma level of creatinine measured on the first postoperative day |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pavel Dostal, MD, Ph.D. | University Hospital Hradec Kralove | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Hradec Kralove | Hradec Králové | 50005 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36422222 | Result | Kukralova L, Dostalova V, Cihlo M, Kraus J, Dostal P. The Impact of Individualized Hemodynamic Management on Intraoperative Fluid Balance and Hemodynamic Interventions during Spine Surgery in the Prone Position: A Prospective Randomized Trial. Medicina (Kaunas). 2022 Nov 20;58(11):1683. doi: 10.3390/medicina58111683. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020896 | Hypovolemia |
| D004487 | Edema |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Noninvasive monitoring group | Procedure | 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). |
|
| 24 hours |
| pooperative lung dysfunction | postoperative lung dysfunction defined as SpO2 value less than 92% or oxygen therapy for more than 6 hours postoperatively | 24 hours |
| the length of postoperative stay | the length of postoperative stay in hospital | till 2 months after surgery |