Surgical Blood Management Using Noninvasive and Continuous Hemoglobin Monitoring(NACHO)

NCT01753960 | Unknown

• 1 other identifier: TASMC-12-IM-0561-12-CTIL
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Number of allogeneic Red Blood Cells (RBC) units transfused intraoperatively

  perioperative period untill the end of surgery

Secondary Outcomes (5)

• 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

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Consenting anesthesiologist
• Anticipate to manage at least 10 cases per month
• At least 3-year post-graduate clinical experience as an anesthesiologist responsible for making transfusion decisions for individual patients

You may not qualify if:

• Not meeting the appropriate licensing requirements
• No being board-certified in Anesthesiology
• Inability or unwillingness to complete study-related procedures, including undergoing training with regards to using and interpreting the monitor data in the operating room
• Eligible patients under the case of the consenting eligible Anesthesiologist.
• 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).
• Consenting patients who are primarily managed by the consenting anesthesiologists participating in the study
• At least one finger available and accessible for performing non-invasive hemoglobin monitoring.
• Any patients who do not fit the criteria for use of sensor, specifically, any patient with nail polish and/or a nail deformity, or obstructed physical access (e.g. due to bandage) to all fingers that would be used for sensor placement, in a manner that interferes with satisfactory sensor placement
• Any patients being monitored with motor evoked potential devices
• Any patients with a known hemoglobinopathy
• Any patients undergoing Cardio-Pulmonary Bypass (CPB)
• Any patients who cannot be transfused or has refused consent for a blood transfusion
• Patients who are moribund/salvage cases as determined by the participating anesthesiologist in charge of management of the patient in the operating room
• Patients being treated by any artificial oxygen carriers within 30 days of hospital stay
• Patients being managed outside of an operating room, or in operating room with conditions not conducive to perform and complete the study procedures (including use of the hemoglobin monitoring device)

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Idit Matot, professor

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Idit Matot, Professor

CONTACT

97236974758; iditm@tasmc.health.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2012
• First Posted: December 20, 2012
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 3, 2013

Record last verified: 2013-01

Locations

IL (1)