Perioperative Fluid Therapy Optimization in Spinal Surgery

University Hospital Hradec Kralove

Status: Completed

Conditions: Hypovolemia; Hypervolemia

Treatments: Procedure: Standard care group; Procedure: Noninvasive monitoring group

Study type: Interventional

Funder types: Other

Identifiers

NCT03644654

UHospital Hradec Kralove

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups

Standard care group

Active Comparator group

Description:

Fluid management will be done according standard care

Treatment:

Procedure: Standard care group

Noninvasive monitoring group

Experimental group

Description:

Fluid management will be provided using noninvasive hemodynamical monitor ClearSight (Edwards)

Treatment:

Procedure: Noninvasive monitoring group