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The purpose of this study is to determine whether Noninvasive and Continuous Hemoglobin Monitoring (NACHO) for Surgical Blood Management affects transfusion decision making algorithm in the operating room.
Blood transfusions are associated with various risks including viral infections, delayed wound healing, transfusion related acute lung injury and cardiovascular complications. Despite limitations, and ongoing efforts to identify and validate other more-physiologically-relevant "triggers" for blood transfusions, hemoglobin-based transfusion triggers are still commonly used in practice, as well as in all currently available transfusion guidelines, alone, or in combination with other parameters. In the operating room the anesthesiologist has to withdraw blood from the patient and send it to the lab or the blood gas machine to achieve hemoglobin levels. It may be suggested that the ability to continuously monitor hemoglobin levels may help physicians to take more appropriate transfusion decisions; i.e, the physicians will either identify critical decreases in hemoglobin levels earlier and respond appropriately or avoid over-transfusing when hemoglobin levels have not decreased yet. Accordingly, monitors of hemoglobin levels are used in the operating theatre in many centers, although their blood-conserving effect has not been proven yet.
We believe that the transfusion decision making algorithm in the operating room relies less heavily on "on spot" measures of hemoglobin levels but rather on patient's comorbidities, expected additional bleeding according to the surgery and the surgeon, the course of the operation (the operating field is "open" and thus surgeons can tell if it is oozing or frank bleeding, if they can control bleeding promptly or not etc..), hemodynamic data available from the different invasive and non-invasive monitors, pressure from the surgeon, etc. It is therefore suggested that continuous monitoring of hemoglobin levels may be less relevant in this environment.
Specific Aims/Hypothesis:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Anesthesiologists without access to data from a continuous noninvasive hemoglobin monitoring device during surgery. | ||
| SpHb group | Anesthesiologists with access to data from a continuous noninvasive hemoglobin monitoring device during surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of allogeneic Red Blood Cells (RBC) units transfused intraoperatively | perioperative period untill the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital stay treatment - Occurrence of any allogeneic RBC transfusions intraoperatively | From end of surgery until 30 days after surgery | |
| Hospital stay treatment - Total number of allogeneic RBC units transfused perioperatively during hospital stay | From end of surgery until 30 days after surgery |
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Anesthesiologists Eligibility Criteria
Inclusion Criteria:
Exclusion Criteria:
Eligible patients under the case of the consenting eligible Anesthesiologist.
Inclusion criteria:
150 Adult patients undergoing major surgeries associated with possibility of significant blood loss (e.g. such that blood is cross-matched and available before the start of the case as per hospital routine practice).
Exclusion criteria:
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Study population in this study is defined at two levels: 1.Consenting eligible Anesthesiologists, and 2. Eligible patients under the case of the consenting eligible Anesthesiologist. Each level has its own eligibility criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Idit Matot, Professor | Contact | 97236974758 | 4758 | iditm@tasmc.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Idit Matot, professor | Tel-Aviv Sourasky Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel-Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Hospital stay treatment - Incidence of new (or worsening of pre-existing) ischemic events | From end of surgery until 30 days after surgery |
| Hospital stay treatment - 30-day mortality | From end of surgery until 30 days after surgery |
| Hospital stay treatment - Length of post-surgery hospital stay | From end of surgery until 30 days after surgery |