Non-invasive Perioperative Hb Monitoring in Spinal Surgery

Blood Loss, Surgical Clinical Trial

Official title:

Evaluating and Comparing the Accuracy of Non-invasive Hemoglobin Monitoring by Spectrophotometry With and Without Digital Nerve Block in Patients Undergoing Spinal Surgery in Sina Hospital During 2016-2017

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02908412
• Other study ID #: IR.TUMS.VCR.REC.1395.110
• Status: Completed
• Phase: Phase 4
• First received: September 15, 2016
• Last updated: April 18, 2018
• Start date: January 4, 2017
• Est. completion date: January 2018

Study information

• Verified date: December 2017
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The decision to transfuse or not to transfuse blood products is one of the main issues in patients undergoing surgery.

The standard laboratory method of hemoglobin assessment is time-consuming, gives intermittent data, and requires venipuncture which is invasive and painful. In the past decade, the use of non-invasive and faster methods, which allow physicians to measure hemoglobin levels at the patient's bedside, have become widespread. One of the tools that make this possible is Spectrophotometric Hemoglobin.

However, one of the main concerns regarding this method is its accuracy. Since the accuracy of this assessment depends on the extent of perfusion of the organ on which the probe is placed, use of digital nerve blocks proposed to increase its accuracy.

This study aims to evaluate the effects of digital nerve block (with bupivacaine) on the accuracy of non-invasive hemoglobin monitoring by spectrophotometry in patients undergoing spinal surgery.

Description:

The decision to transfuse or not to transfuse blood products is one of the main issues in healthcare systems. Timely transfusion of blood to a patient bleeding, either due to the surgery or because of the trauma, can prevent tissue hypoxia and ischemia in vital organs. However, transfusion of blood products should be done carefully and cautiously due to the potential complications of transfusions, and also because of the cost of providing blood products 1, 2, 3. Hence, during surgeries, hemoglobin level has a vital role in the diagnosis and management of patients with anemia.

The standard laboratory method of hemoglobin assessment is time-consuming, gives intermittent data, and requires venipuncture which is invasive and painful. In the past decade, the use of non-invasive and faster methods, which allow physicians to measure hemoglobin levels at the patient's bedside, have become widespread. One of the tools that make this possible is Spectrophotometric Hemoglobin (SpHb Masimo Rainbow Co-oximeter). This procedure is applied by a digital probe and allows physicians to monitor hemoglobin levels continuously. 4, 5, 6 However, one of the main concerns regarding this method is its accuracy. Actually, the difference between the measured hemoglobin level and the actual hemoglobin level of the patient, might make it impossible for physicians to decide with sufficient confidence3.

From the time that SpHb has been available in operating rooms, various studies have evaluated its accuracy. While its accuracy has been reported relatively acceptable (mean difference is about 1-1.5 g/dl comparing to the lab data),4 there are still concerns regarding this issue. Furthermore, it is not clear whether this difference would remain the same during the surgery or not. Because blood transfusion is rarely needed when the hemoglobin level of patient is higher than 10g/dl during the surgery. Also, blood transfusion becomes obviously necessary if hemoglobin levels drop to 6g/dl or lower during the surgery. Therefore, the accuracy of the tool in assessing hemoglobin levels at this critical interval (6-10g/dl) is of greater importance.6,7 Experimental studies have confirmed that accuracy could change in different hemoglobin levels5,8, and with the passage of time.9 In addition, it has been reported that after significant blood loss or even following injection of blood, the average difference between SpHb and laboratory might change, as well. 5,8 Since the accuracy of this assessment depends on the extent of perfusion of the organ on which the probe is placed, methods that enhance blood circulation in the organ (including local heating of the organ and use of digital nerve blocks (DNB), proposed to increase its accuracy.10, 11 In a study conducted in 2012 by Miller et al. on 20 patients undergoing spinal surgery, DNB was performed using lidocaine. The differences between SpHb and lab hemoglobin were recorded first after injection, and then at almost hourly intervals. These differences were compared to data from another study without DNB. Thirty seven percent of data in the intervention group and 12% of data in the control group was considered as "very accurate". Results of this study showed that DNB increased perfusion indices and SpHb accuracy.10 Following the previous study, Miller et al. carried out a study in 2014 to compare the effects of DNB with lidocaine and bupivacaine on 12 healthy volunteers. DNB was performed on two identical fingers on both hands of the volunteers. Lidocaine was used on one hand and bupivacaine on the other one. Results of this study showed that both lidocaine and bupivacaine raised the perfusion indices and temperatures of the fingers. The duration and extent of the rise in temperature were more for bupivacaine, and there was a direct correlation between changes in perfusion index and those in SpHb.11 Since, the previous study data had been gathered from healthy individuals, this study aims at investigate the effects of DNB on the accuracy SpHb in patients undergoing surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: All patients 18 years of age or older, admitted to Sina hospital to have spinal surgery, whose surgery is not an emergency, are included in the study. Moreover, the patients must be in grade 2 or lower according to the ASA Physical Status Classification, and volunteer to participate in the study.

Exclusion Criteria: Patients who are going to have an emergency surgery are excluded from the study. Also patients with grade 3 ASA or higher, or the ones suffering from anatomic or vascular disorders that cause problems in attaching the SpHb sensor, are excluded from the study.

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage

Intervention

Drug:
• Digital nerve block with bupivacaine
The aim of the study, the way it will be conducted, and the complications and possible risks are explained to them. written informed consent is obtained from them. Then, after induction of anaesthesia, an arterial line will be inserted in order to monitor blood pressure and to take blood samples. During the surgery, two rainbow adult ReSposable sensors will be attached to the third or fourth fingers of both hands, and each of sensors will be attached to a monitor. Patients will be randomly assigned to two groups: group A will receive DNB in left hand and group B will receive DNB in right hand. DNB will be performed by injecting 2 ml of 0.25% bupivacaine at the base of medial and lateral sides of the finger attached to the sensor (1 ml on each side of the base).

Locations

Country	Name	City	State
Iran, Islamic Republic of	Sina Hospital	Tehran	Tehtan

Sponsors (2)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences	Sina Trauma and Surgery Research Center

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (11)

Applegate RL 2nd, Barr SJ, Collier CE, Rook JL, Mangus DB, Allard MW. Evaluation of pulse cooximetry in patients undergoing abdominal or pelvic surgery. Anesthesiology. 2012 Jan;116(1):65-72. doi: 10.1097/ALN.0b013e31823d774f. — View Citation

Barker SJ, Shander A, Ramsay MA. Continuous Noninvasive Hemoglobin Monitoring: A Measured Response to a Critical Review. Anesth Analg. 2016 Feb;122(2):565-72. doi: 10.1213/ANE.0000000000000605. Review. — View Citation

Giraud B, Frasca D, Debaene B, Mimoz O. Comparison of haemoglobin measurement methods in the operating theatre. Br J Anaesth. 2013 Dec;111(6):946-54. doi: 10.1093/bja/aet252. Epub 2013 Jul 17. — View Citation

Kim SH, Lilot M, Murphy LS, Sidhu KS, Yu Z, Rinehart J, Cannesson M. Accuracy of continuous noninvasive hemoglobin monitoring: a systematic review and meta-analysis. Anesth Analg. 2014 Aug;119(2):332-46. doi: 10.1213/ANE.0000000000000272. Review. — View Citation

Lamhaut L, Apriotesei R, Combes X, Lejay M, Carli P, Vivien B. Comparison of the accuracy of noninvasive hemoglobin monitoring by spectrophotometry (SpHb) and HemoCue® with automated laboratory hemoglobin measurement. Anesthesiology. 2011 Sep;115(3):548-54. doi: 10.1097/ALN.0b013e3182270c22. — View Citation

Miller RD, Ward TA, McCulloch CE, Cohen NH. A comparison of lidocaine and bupivacaine digital nerve blocks on noninvasive continuous hemoglobin monitoring in a randomized trial in volunteers. Anesth Analg. 2014 Apr;118(4):766-71. doi: 10.1213/ANE.0000000000000144. — View Citation

Miller RD, Ward TA, McCulloch CE, Cohen NH. Does a digital regional nerve block improve the accuracy of noninvasive hemoglobin monitoring? J Anesth. 2012 Dec;26(6):845-50. doi: 10.1007/s00540-012-1452-0. Epub 2012 Aug 1. — View Citation

Miller RD, Ward TA, Shiboski SC, Cohen NH. A comparison of three methods of hemoglobin monitoring in patients undergoing spine surgery. Anesth Analg. 2011 Apr;112(4):858-63. doi: 10.1213/ANE.0b013e31820eecd1. Epub 2011 Mar 8. — View Citation

Park YH, Lee JH, Song HG, Byon HJ, Kim HS, Kim JT. The accuracy of noninvasive hemoglobin monitoring using the radical-7 pulse CO-Oximeter in children undergoing neurosurgery. Anesth Analg. 2012 Dec;115(6):1302-7. doi: 10.1213/ANE.0b013e31826b7e38. Epub 2012 Nov 9. — View Citation

Rice MJ, Gravenstein N, Morey TE. Noninvasive hemoglobin monitoring: how accurate is enough? Anesth Analg. 2013 Oct;117(4):902-7. doi: 10.1213/ANE.0b013e31829483fb. Epub 2013 Jul 10. Review. — View Citation

Suehiro K, Joosten A, Alexander B, Cannesson M. Continuous noninvasive hemoglobin monitoring: ready for prime time? Curr Opin Crit Care. 2015 Jun;21(3):265-70. doi: 10.1097/MCC.0000000000000197. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	accuracy of SpHb	in each patient, Sphb values will be documented for both hands. Also, the arterial blood sample (lab Hb) will be sent to the laboratory. The difference between two measure in each hand (with or without DNB) shows the accuracy of Sphb for each hand.	At the start of the operation, once every 1.5 hours during the operation till its end
Secondary	Perfusion index (PI)	In each patient, PI value of hand with DNB will be compared to PI measure in the other hand.	At the start of the operation, once every 1.5 hours during the operation till its end
Secondary	Pleth Variability Index (PVI)	In each patient, PVI value of hand with DNB will be compared to PI measure in the other hand.	At the start of the operation, once every 1.5 hours during the operation till its end