Impact of SpHb Monitoring on Transfusion

NCT01906515 | Completed Results DMC

• 1 other identifier: doctor19
• Study Type: interventional
• Target: 106
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anemia

Keywords

Anemia; Blood transfusion; non invasive hemoglobin monitoring; patient safety

Outcome Measures

Primary Outcomes (2)

• RBC Transfusions Per Subject Receiving a Transfusion

  Determine whether using SpHb can affect the quantity of RBC transfused, per patient receiving a transfusion.

  During surgery (an average of about 4 hours)

• The Effect of SpHb on Transfusion Timeline

  Length of time it takes to initiate a RBC transfusion after the need was first established.

  During surgery (an average of about 4 hours)

Secondary Outcomes (1)

• SpHb Absolute and Trend Accuracy

  During surgery (an average of about 4 hours)

Other Outcomes (1)

• Potential Cost Savings

  During surgery (an average of about 4 hours)

Study Arms (2)

Control Group

NO INTERVENTION

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.

SpHb Group.

EXPERIMENTAL

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

Device: Continuous non-invasive hemoglobin monitoring

Interventions

Continuous non-invasive hemoglobin monitoring DEVICE

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

Also known as: Masimo Radical-7 with SpHb

SpHb Group.

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• Cairo University: lead
• Masimo Corporation: collaborator

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Dr Wael N Awada
• Organization: Cairo University School Of Medicine

waoool@hotmail.com

00201006481958

Study Officials

• Wael N Awada, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer Cairo University

Study Record Dates

• First Submitted: July 13, 2013
• First Posted: July 24, 2013
• Study Start: February 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 27, 2014
• Results First Posted: January 20, 2014

Record last verified: 2014-01