Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT01753960
Eligibility Criteria:
1. Anesthesiologists Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
2. 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).
* 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.
Exclusion criteria:
* 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)
* Patients younger than 18 years old
* Patients who are pregnant
* Any patients expected to receive transfusion preoperatively
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01753960
Study Brief:
Protocol Section:
NCT01753960