Perioperative Fluid Therapy Optimization in Spinal Surgery

NCT ID: NCT03644654

Last Updated: 2022-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-21
• Study Completion Date: 2020-07-30

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.

Conditions

Hypovolemia; Hypervolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard care group

Fluid management will be done according standard care

Group Type: ACTIVE_COMPARATOR

Standard care group

Intervention Type: 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).

Noninvasive monitoring group

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

Group Type: EXPERIMENTAL

Noninvasive monitoring group

Intervention Type: 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).

Interventions

Standard 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).

Intervention Type: PROCEDURE

Noninvasive 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).

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Hradec Kralove

OTHER

Sponsor Role: lead

Responsible Party

Dostalova Vlasta, MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pavel Dostal, MD, Ph.D.

Role: STUDY_DIRECTOR

University Hospital Hradec Kralove

Locations

University Hospital Hradec Kralove

Hradec Králové, , Czechia

Countries

Czechia

References

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.

Reference Type: RESULT

PMID: 36422222 (View on PubMed)

Other Identifiers

UHospital Hradec Kralove

Identifier Type: -

Identifier Source: org_study_id