Effect of Goal-directed Fluid Management Guided by Non-invasive Device on Incidence of Postoperative Complications in Neurosurgery: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Completeness of Case Report Forms
研究概览
简要总结
The purpose of the study is to assess feasibility of future large randomised controled study aimed on assessment of effect of goal-directed therapy on incidence of complications in neurosurgery compared to standard care.
详细描述
Patients undergoing neurosurgical operations are at risk of inadequate intravascular volume for several reasons. The appropriate fluid management in neurosurgery is a challenge. Goal-directed therapy has been shown to improve the outcome of patients undergoing major surgery. Current knowledge regarding effect of fluid management on patient-orientated outcomes in neurosurgery is limited.
This study is designed as a pilot study with two parallel groups. Patients scheduled to planned brain surgery at the University Hospital Brno will be screened whether they meet the inclusion criteria. After obtaining informed consent, the patient will be randomized to one of the study arms.
In one arm (STANDARD) standard monitoring of vital signs will be introduced. During the operation, perioperative fluid therapy and administration of vasoactive agents will depend entirely at the discretion of the attending anaesthetist. Postoperative therapy will be fully controlled and will depend on the decision of the attending physician. In the second arm (GDT), a non-invasive hemodynamic monitor STARLINK™SV will be introduced in addition to standard monitoring. In this arm, basal infusion with crystalloid balanced solution will be initiated. Additional boluses of fluids will be administered based on haemodynamic monitoring. The primary outcome of the study is a proportion of patients with serious adverse event (SAE). Incidence of SAEs will be compared between study groups. SAE will be defined as unsatisfactory brain tissue relaxation at the end of operation and any intervention for brain oedema postoperatively.
The secondary outcome is to compare proportion of patients with postoperative complications in both groups and length of ICU and hospital stay.
This study will enroll 34 patients in total, 17 in each group. After completion of enrolment of patients the statistical analysis will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age at least 18 years
- •anticipated duration of surgery at least 2 hours
- •signed written consent form
- •American Society of Anesthesiologists (ASA) classification < 4.
排除标准
- •unavailability of hemodynamic monitor
- •emergency operation
- •sitting operating position and awake craniotomy
- •awake craniotomy
- •serious cardiorespiratory disorder
- •cardiac arrythmia
- •obesity with BMI above 35 kg/m2
结局指标
主要结局
Completeness of Case Report Forms
时间窗: through study completion, an average of 6 months
Proportion of enrolled patients with completed Case Report Form.
Serious Adverse Events 2
时间窗: 24 hours postoperatively
Assessment of number of patients with serious adverse event (SAE). SAE is defined as any intervention indicated for treatment of brain edema 24 hours after surgery.
Recruitment rate
时间窗: through study completion, an average of 6 months
Proportion of eligible patients who consent to participate in the study.
Serious Adverse Events 1
时间窗: During the Surgery
Assessment of number of patients with serious adverse event (SAE). SAE is defined as unsatisfactory brain tissue relaxation at the end of surgery assessed by neurosurgeon. Level 3 or 4 of brain tissue relaxation will be considered as unsatisfactory (level 1 - completely relaxed, level 2 - satisfactorily relaxed, level 3 - firm, level 4 - bulging).
次要结局
- Complications(through study completion, an average of 6 months)
研究者
Ondrej Hrdy
Principal Investigator
Brno University Hospital