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New finger sensor aims to reduce blood transfusions in surgery

NCT ID NCT02986789

Knowledge-focused Sponsor: Masimo Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a special finger sensor that measures hemoglobin and fluid levels without needles during surgery. The goal was to see if this real-time information helps doctors decide when to give blood transfusions, potentially reducing the amount of donor blood needed. The study included 43 adults undergoing major surgeries with expected blood loss, but it was terminated early, so the findings are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pulse oximeter finger sensor (noninvasive hemoglobin and pleth variability index monitoring)
What this could lead to
If successful, this could help doctors make better decisions about blood transfusions during surgery, potentially reducing the need for donor blood.
What could go wrong
The study was terminated early with only 43 participants, so results are limited. The device may not improve outcomes for all surgical patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

43 people

The number who actually took part.

Started

Dec 2016

Finished

Aug 2018

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) under general anesthesia. * At least one finger available and accessible for performing non-invasive hemoglobin monitoring. Exclusion Criteria: * Patient has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent the proper fit and application of the sensors * Procedures performed using robotics surgery * 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 being treated by any artificial oxygen carriers within 30 days of hospital stay * Patients being managed outside of an operating room in the participating centers, 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 * Patients with cardiac arrhythmia * Patients with tidal volume setting \< 6ml/kg * Patients with PEEP \>= 10cm H2O * Patients undergoing cardiac and/or any open chest procedures * Emergency patients due to the foreseeable difficulty in consenting * Patients deemed not suitable for study at the discretion of the Principal Investigator

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Surgery

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