Intra-operative Monitoring of Blood Loss

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Undetected Intraoperative Blood Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hb group:15 patients

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

blood transfusion, intermittent Hbsatlab measurement

Intervention Type PROCEDURE

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.

blood transfusion, based on continuous SpHb readings

Intervention Type PROCEDURE

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.

Interventions

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blood transfusion, intermittent Hbsatlab measurement

In the Hbsatlab group, RBC administration and its timing will be based on intermittent Hbsatlab measurement (routine care)

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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