Comparison of Pulse Hemoglobin and Pleth Variability Index

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

299 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2018-02-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to investigate whether a validated sensor that is able to measure how much oxygen-carrying molecules called hemoglobin using pulse hemoglobin and Pleth Variability Index (PVI)\] are in your blood during surgery can help your doctors manage how much fluid and possibly blood you need to get during your surgery. The hope of the study is that the device may provide an early indication you are having bleeding and this may mean you need to be treated with a transfusion. Our current method of checking this is by getting a blood sample for analysis. The investigators hope is that this device may be able to alert the clinician of the need for blood or fluids without a blood draw being needed.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Validation of Noninvasive Hemoglobin, Comparison of PVI to Standard Methods, and Validation of Clinical Efficacy of ORI

NCT02841397

Surgery

COMPLETED

Continuous Non-Invasive SpHb and PVI Monitoring on Intra-Operative and Post-Surgical Clinical Outcomes

NCT02986789

Surgery

TERMINATED

Evaluation of the Accuracy and Precision of the Masimo Labs Pulse-Hemoglobin-Meter Monitor in Surgical Patients

NCT00762398

Adult Patient Undergoing Major Surgery

TERMINATED

Plethysmography Variability Index Monitoring for Parturients With Antepartum Hemorrhage

NCT02614053

Antepartum Hemorrhage

UNKNOWN

Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor

NCT03124901

Surgery Healthy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anemia Fluid Management

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects must be \>18 years old;
* must be having a major surgical procedure;
* The pre-operative estimation of blood loss must be at least 15% of the total blood volume

Exclusion Criteria

* Does subject have hemoglobinopathy;
* cardiac arrhythmias producing irregular rhythms;
* severe pulmonary disease;
* procedures where loss of more that 10 to 15% of total blood volume is unlikely;
* subject refusal

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No