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临床试验/NCT03909711
NCT03909711Unknown不适用

Relationship Between Temperature and Intraoperative Bleeding in Patients Undergoing Multilevel Spinal Surgery: Prospective, Multicenter Study

University of Roma La Sapienza1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年5月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
correlation between temperature and bleeding

研究概览

简要总结

The primary objective of this multicentric observational study is to define the role of intraoperative temperature decrease (defined as reduction of at least 1 ° C during surgery) as haemorrhagic risk factor, evaluated as reduction of at least 1 gr / dl of hemoglobin, and to correlate it with the need for transfusion. Secondary objectives are infections and complications affecting other organs and systems incidence in the first week after surgery.

详细描述

In this prospective, observational, multicentric study, after ethics committee approval and patients informed consent, 20 patients for each center undergoing elective multi-level spine surgery procedures will be enrolled. A total of 80 patients will be enrolled. No randomization or concealment is planned.

Inclusion criteria are: adults (age> 18), American Society of Anesthesiologists (ASA) I-III, undergoing elective multi-level spinal surgery intervention. Patients with significant comorbidities such as severe liver disease, severe renal disease (stage III-IV), heart disease with organ failure, severe preoperative anemia requiring blood transfusions, severe pneumopathy with high probability of postoperative prolonged mechanical ventilation are excluded. Other exclusion criteria are: emergency intervention, known coagulopathy and chronic preoperative anemia.

Temperature will be measured with tympanic, anal or esophageal probe according to the availability and means of the department. Variables related to the patient (such as sex, age, BMI, smoke, anticoagulant or antiplatelet therapy in progress, presence of mild chronic hepatopathy / cardiopathy / pneumopathy / renal failure, hemoglobin and the preoperative hematocrit) will be compared with type and length of intervention, estimated blood loss, intraoperative variables (such as diuresis, minimum temperature and its variations, blood transfusions, ventilation mode) and post- operative hemoglobin level (the day after operation) to assess patient prognosis in terms of need for transfusion and infectious and respiratory complications incidence 7 days after surgery.

For each patient will be measured initial intraoperative temperature (T0) and minimum temperature (Tmin) with esophageal, anal or tympanic probe every 30 minutes during surgery. The temperature delta will be calculated as T0 - Tmin.

the investigators will compare intraoperative reduction of basal body temperature with Hb level reduction (preoperative Hb compared to Hb of the following day of intervention) considering as significant a temperature reduction of at least 1 ° C and Hb reduction of at least 1 g/dl, net of variables recognized correlated with increased bleeding in vertebral surgery (age, sex, diabetes mellitus, smoking, arterial hypertension, ASA class, intervention time, preoperative Ht) and liquid volume infused during intervention (hemodilution).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults (age> 18)
  • ASA I-III
  • elective spinal surgery
  • multi-level surgery

排除标准

  • significant comorbidities such as severe liver disease, severe renal disease (stage III-IV), heart disease with organ failure, severe preoperative anemia requiring blood transfusions, severe pneumopathy with high probability of postoperative prolonged mechanical ventilation are excluded
  • emergency intervention
  • known coagulopathy
  • chronic preoperative anemia.

结局指标

主要结局

correlation between temperature and bleeding

时间窗: the investigators are recruiting patients from November 2018 to November 2019

the investigators aim to evaluate if temperature influence the bleeding of patients and which temperature seems to be the best (normothermia versus hypothermia). the investigators consider as significant bleeding the lost of at least 1 point of hemoglobin (lost \>1mg/dl), and hypothermia the loss of at least 1°C of the body temperature

次要结局

  • Infections and complications related to bleeding(the investigators are recruiting patients from November 2018 to November 2019)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Federico Bilotta

Medical Doctor, Phisician Doctor

University of Roma La Sapienza

研究点 (1)

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