Clinical Trials Logo
  1. Home
  2. Blood Loss
  3. NCT01604668
  4. Details
NCT01604668 Clinical Trial

Comparative Accuracy of Three Versions of Non-Invasive Hemoglobin Monitoring

Blood Loss Clinical Trial

Official title:
Comparative Accuracy of Three Versions of Non-Invasive Hemoglobin Monitoring.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01604668
Other study ID # 1000524C
Secondary ID
Status Completed
Phase N/A
First received May 18, 2012
Last updated August 19, 2013
Start date May 2012
Est. completion date May 2013

Study information
Verified date August 2013
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

There is no study hypothesis. The purpose of this study is to compare the accuracy of the: 1) SpHb (Radical 7 Pulse Co-Oximetry with SpHb™) RevF sensor (currently marketed), 2) the SpHb RevG sensor (a new, limited release version), and 3) the Pronto-7 sensor (currently marketed version) in patients undergoing spine surgery.

Description:

The purpose of this study is to compare the accuracy of the: 1) SpHb RevF sensor (currently marketed), 2) the SpHb RevG sensor (a new, limited release version), and 3) the Pronto-7 sensor (currently marketed version) in patients undergoing spine surgery. The results from the three sensors will be compared to a blood hemoglobin level taken intermittently (as a function of the patient's anesthesia care) and analyzed in the UCSF Clinical Laboratories.

This is an observational study.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- = 18 years of age

- ASA Classification 1, 2 or 3

- Scheduled to undergo spine surgery

Exclusion Criteria:

- Pregnant of nursing

- In the investigator's judgement would not be suitable for research

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of California, San Francisco Moffitt/Long Hospitals San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (1)

Miller RD, Ward TA, Shiboski SC, Cohen NH. A comparison of three methods of hemoglobin monitoring in patients undergoing spine surgery. Anesth Analg. 2011 Apr;112(4):858-63. doi: 10.1213/ANE.0b013e31820eecd1. Epub 2011 Mar 8. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of hemoglobin levels derived by sensor RevF versus sensor RevG versus a hemoglobin derived from a blood sample. A baseline hemoglobin level will be taken from the Pronto-7 hand-held hemoglobin device prior to surgery. Comparison of hemoglobin levels derived by sensor RevF versus sensor RevG versus a hemoglobin derived from a blood sample. A baseline hemoglobin level will be taken from the Pronto-7 hand-held hemoglobin device prior to surgery. Two or more measurements during surgery No
See also
  Status Clinical Trial Phase
Completed NCT04588350 - Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery N/A
Completed NCT05426564 - Exploratory Assessment of the Quantra® System in Adult ECMO Patients
Active, not recruiting NCT05492214 - The Effect of Time Window for Umbilical Cord Clamping During Cesareans on Offspring Hemoglobin and Maternal Blood Loss N/A
Withdrawn NCT05518279 - Early Administration Of Tranexamic Acid And Acute Blood Loss In Patients With Hip Fractures Phase 3
Enrolling by invitation NCT02910115 - Cooling the Uterus in C-section After Dysfunctional Labor N/A
Completed NCT02569658 - Investigation of Intravenous Tranexamic Acid With Anatomic and Reverse Total Shoulder Arthroplasty N/A
Completed NCT01048658 - Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures Phase 4
Terminated NCT02908516 - Safety and Efficacy of Oral TXA in Reducing Blood Loss and Transfusion in Hip Fractures Phase 4
Completed NCT04089865 - Oral Versus Intravenous Tranexamic Acid Phase 4
Recruiting NCT06403163 - Transfusion Surveillance in Anaesthesia
Recruiting NCT02265562 - Rectal Misoprostol and Blood Loss During Abdominal Hysterectomy Phase 3
Completed NCT02312440 - Comparison of Topical and Intravenous Tranexamic Acid in Total Hip Arthroplasty Phase 3
Completed NCT02083809 - Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation N/A
Completed NCT01895101 - The Effect on Blood Loss of Topical and Intravenous Tranexamic Acid in Cardiac Surgery Patients Phase 4
Completed NCT01099475 - Effect of Intermittent Pedicle Clamping on Hepatocellular Injury During Liver Surgery N/A
Completed NCT00990288 - The Use of FLOSEAL to Reduce Bleeding in Total Knee Replacement Surgery Phase 4
Completed NCT03365999 - Oral Tranexamic Acid vs. Oral Aminocaproic Acid to Reduce Blood Loss and Transfusion After Total Knee Replacement. Phase 2
Recruiting NCT05550623 - Pneumatic Tourniquet Versus no Tourniquet in Transfemoral Amputation N/A
Completed NCT05012202 - Validating a New Point-of-care Device for Estimation of Blood Count in Pregnant Women
Completed NCT02311309 - Epidemiology of Severe Peroperative Bleeding During Scheduled Surgery N/A