Impact of SpHb Monitoring on Transfusion

NCT ID: NCT01906515

Last Updated: 2014-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-12-31

Brief Summary

Continuous and noninvasive hemoglobin (SpHb) monitoring provides clinicians with real-time trending of changes or lack of changes in hemoglobin, which has the potential to alter red blood cell (RBC) transfusion decision making. The objective of this study was to evaluate the impact of SpHb monitoring on RBC transfusions in high blood loss surgery. The investigators hypothesize that SpHb will improve blood transfusion practice in the for of change the number of blood unit per patient and improve the outcome regards the time to take decision of transfusion trigger.

Detailed Description

Eligible patients scheduled for neurosurgeries were enrolled into either a standard care group (Control Group) or an intervention group (SpHb Group). The Control Group received typical anesthesia care including estimated blood loss (EBL) assessment and intraoperative hemoglobin measurements from the central laboratory (Hb). Blood samples were taken when EBL was ≥15% of total blood volume. RBC transfusion was initiated if Hb was ≤10 g/dL and continued until the EBL was replaced and Hb >10g/dL was confirmed. The SpHb Group followed the same transfusion practice as the Control Group except the anesthesiologist was guided by the addition of SpHb monitoring with blood samples still taken pre- and post-transfusion. Additionally, the absolute and trend accuracy of SpHb compared to Hb was evaluated. Potential cost savings from reduced RBC utilization will be calculated if occured.

Conditions

Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control Group

Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.

Group Type: NO_INTERVENTION

No interventions assigned to this group

SpHb Group.

Continuous non-invasive hemoglobin monitoring (SpHb monitoring) was provided to the anesthesiologist to influence administration of care

Group Type: EXPERIMENTAL

Continuous non-invasive hemoglobin monitoring

Intervention Type: DEVICE

Anesthesiologist is provided with real-time continuous non-invasive hemoglobin monitoring to influence care provided to patient

Interventions

Continuous non-invasive hemoglobin monitoring

Anesthesiologist is provided with real-time continuous non-invasive hemoglobin monitoring to influence care provided to patient

Intervention Type: DEVICE

Other Intervention Names

Masimo Radical-7 with SpHb

Eligibility Criteria

Inclusion Criteria

• ASA 1,2 patients from 15 to 60 years old scheduled for neurosurgical procedure

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masimo Corporation

INDUSTRY

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

wael awada

Assistant Lecturer Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wael N Awada, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia, ICU, and Pain Management, Cairo University, Egypt

Other Identifiers

doctor19

Identifier Type: -

Identifier Source: org_study_id