Intra-operative Monitoring of Blood Loss

Monitoring of Intraoperative Blood Loss: Benefit of Continuous Noninvasive Haemoglobin Monitoring?

Certain types of surgery are associated with occult blood loss, which is hard to detect intraoperatively by intermittent conventional, invasive Hb concentration measurements using the clinical standard of Hb monitoring by satellite laboratory analysis (Hbsatlab). The investigators want to see whether continuous non-invasive transcutaneous Hb measurement using a finger sensor (SpHb), (a) reduces the total time (area under the curve, AUC) a patient's Hb is below a predetermined transfusion threshold (HbAUC) for administration of red blood cell concentrate (RBC), and (b) prevents a decrease in total oxygen delivery (DO2) possibly associated with transfusion below a critical haemoglobin concentration. Furthermore, the investigators want to study if SpHb monitoring changes the timing of RBC administration and reduces the need for intra- and post-operative RBC transfusion.

Study Overview

• Status: Completed
• Conditions: Undetected Intraoperative Blood Loss
• Intervention / Treatment: Procedure: blood transfusion, intermittent Hbsatlab measurement; Procedure: blood transfusion, based on continuous SpHb readings

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713EZ
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

30 adult patients scheduled for surgery associated with undetected, i.e., difficult to reliably monitor intraoperative blood loss

Description

Inclusion Criteria:

• Patients at the age of 18 years or older, planned for elective surgery at-risk for undetected blood loss.
• American Society of Anesthesiologists (ASA) classification I, II, III, IV

Exclusion Criteria:

• Patient refusal
• Emergency surgery

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hb group:15 patients; scheduled for elective surgery associated with undetected, i.e., difficult to reliably monitor intraoperative blood loss.	Procedure: blood transfusion, intermittent Hbsatlab measurement; In the Hbsatlab group, RBC administration and its timing will be based on intermittent Hbsatlab measurement (routine care)
SpHb group: 15 patients; scheduled for elective surgery associated with undetected, i.e., difficult to reliably monitor intraoperative blood loss.	Procedure: blood transfusion, based on continuous SpHb readings; RBC administration and its timing will be based on continuous SpHb readings while Hbsatlab values, measured every 30 min. by an objective observer, will not be visible to the attending anaesthetist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbAUC	the total time a patient's Hb is below a predetermined transfusion threshold (HbAUC) for administration of red blood cell concentrate	during operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood transfusions	the number of perioperative blood transfusions	intra- and post operative up to 48h

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
DO2	DO2 = oxygen delivery	intraoperative
serum concentrations of high-sensitive troponin T	serum concentrations of high-sensitive troponin T	post operative up to 48h
serum concentrations of lactate	lactate	intra- and post operative up to 48h
StO2	StO2 = peripheral tissue oxygenation by near-infrared spectroscopy	intraoperative

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: Michel M.R.F. Struys, Prof.dr, University of groningen,University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: May 22, 2013
• First Submitted That Met QC Criteria: May 25, 2013
• First Posted (Estimate): May 30, 2013

Study Record Updates

• Last Update Posted (Estimate): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 26, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: bleeding SpHb-001