Clinical Trials Directory

Trials / Completed

CompletedNCT01864980

Intra-operative Monitoring of Blood Loss

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

Status
Completed
Phase
Study type
Observational
Enrollment
30 (actual)
Sponsor
University Medical Center Groningen · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREblood transfusion, intermittent Hbsatlab measurementIn the Hbsatlab group, RBC administration and its timing will be based on intermittent Hbsatlab measurement (routine care)
PROCEDUREblood transfusion, based on continuous SpHb readingsRBC 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.

Timeline

Start date
2013-06-01
Primary completion
2014-05-01
Completion
2014-05-01
First posted
2013-05-30
Last updated
2015-05-27

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT01864980. Inclusion in this directory is not an endorsement.