跳至主要内容
临床试验/CTRI/2015/04/005685
CTRI/2015/04/005685已完成不适用

To Study The Utility Of Non-Invasive Spectrophotometric Hemoglobin (SpHb) Monitoring During Major Oncological Surgeries.

Rajiv Gandhi Cancer Institute1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年8月21日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Real time hemoglobin monitoring for faster assessment of blood loss and effective decision making for blood transfusion during intraoperative period.

研究概览

简要总结

Synopsis Of Study Protocol Submission

Department: Department Of Anesthesiology And Intensive Care, Rajiv Gandhi Cancer Institute And Research Centre

Candidate: Dr. Namrata Gupta, DNB Resident Anesthesiology.

Title: To Study The Utility Of Non-Invasive Spectrophotometric Hemoglobin (Sphb) Monitoring During Major Oncological Surgeries.

Aim: To evaluate the efficacy of SpHb in managing blood transfusions during intraoperative period using Radical-7®; Masimo Corp. in centre with high volume of oncosurgeries involving major blood loss.

Objective: To study and compare the of SpHb values with Laboratory Hemoglobin (LabHb) values by using Radical-7®; Masimo Corp., Irvine, CA and COULTER® LH 750 Hematology Analyzer respectively during major oncological surgeries in following aspects;

1.      Accuracy of SpHb in comparison with LabHb

2.      Accuracy of SpHb as transfusion trigger in comparison with LabHb.

3.      Correlation of SpHb and perfusion index.

 Inclusion Criteria: - ASA Grade I, II, III patient undergoing major elective oncosurgeries with expected blood loss more than 20% of blood volume between Age group above 18 years and preoperative hemoglobin 8-14gm/dl.

Exclusion Criteria:

  • Patient with known Hemoglobinopathies, arrhythmias, severe hypotension.

  • Peripheral Vascular disease like Raynaud’s disease.

  • Any skin abnormalities affecting the digits.

  • Patient on antipsychotic drugs and patient having high total bilirubin levels.

 Study Protocol: Informed written consent will be taken from 50 patients undergoing surgery with anticipated blood loss of >20% of blood volume. Continuous SpHb monitoring will be done using Radical-7®; Masimo Corp., and LabHb will be sent at specific time points at blood loss of every 500ml and its multiples. Blood transfusion will be managed on the basis of clinical criteria and SpHb values of 8-10 gm% as per order by attending anesthesiologist. Study design will be prospective case control study.

 Source of funding: nil

Conflict of interest: nil

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • ASA Grade I, II, III patient undergoing major elective oncosurgeries with expected blood loss more than 20% of blood volume.

排除标准

  • Patient with known Hemoglobinopathies, arrhythmias, severe hypotension.
  • Peripheral Vascular disease like Raynaud’s disease.
  • Any skin abnormalities affecting the digits.
  • Patient on antipsychotic drugs and patient having high total bilirubin levels.

结局指标

主要结局

Real time hemoglobin monitoring for faster assessment of blood loss and effective decision making for blood transfusion during intraoperative period.

时间窗: every time blood loss exceed 500 ml or hourly whichever is earlier

次要结局

  • requirement of postoperative blood transfusion and any complication due to intraoperative blood loss and transfusion.(up to 48hrs.)

研究者

申办方类型
Private hospital/clinic

研究点 (1)

Loading locations...

相似试验