Non Invasive Oxygen Reserve Index (ORI) Measurement via Pulse Co-Oximetry in Pediatric Patients

Study ID
STU 092013-025

Cancer Related

Healthy Volunteers

Study Sites

  • Children’s Medical Center (Dallas, Plano, Southlake)

Allison Griffin

Principal Investigator
Peter Szmuk, M.D.


Patient demographics (age and weight) will be collected for 200 consecutive patients presenting for surgical procedures which would require intubation or LMa placement.

For each patient enrolled in this study, up to 6 pulse co-oximeter sensors, either FDa cleared pulse co-oximeter sensors or investigational pulse co-oximeter sensors (Masimo, irvine Ca), will be placed on the subject's fingers, toes, and/or nose prior to induction of anesthesia and connected to the Masimo Radical-7 (Masimo, irvine Ca). The monitor will then be connected to a laptop. oxygen saturation and the oxygen Reserve index (oRi) will be recorded continuously on automated data collection (aDC) software from the time that sensors placed on the patient are connected to the Radical-7 monitor to study completion as defined in the following sections of this protocol. oxygen will be administered according to the general anesthesia airway management sequence detailed below.

airway Management
The laryngoscopy and intubations will be performed as standard of care by the study investigators who are faculty anesthesiologists or by the mid-level/mid-level trainee or fellow/resident working with them. When SPo2% reaches 96%, the patient will be reconnected to the anesthesia circuit and ventilated with 100% o2 through either the eTT or LMa.

General anesthesia x airway management sequence:
* Mask induction with spontaneous ventilation
oBaseline Spo2 recording on room air for approximately one minute
o3-4 minutes recording at 100% oxygen and sevofluorane via face mask
* intravenous cannula placement
* The rest of the anesthetic management will be at the discretion of the investigator and dependent on the depth of anesthesia
* intubation (insertion of the eTT through the vocal cords) or LMa placement as standard of care
* Connection of the eTT or LMa to the anesthesia circuit
* Bag ventilation and correct eTT placement or LMa placement by observing the eTCo2 waveform and by auscultation.
-The eTT or LMa will be disconnected and the SPo2 will be allowed to drift to 96% and at that point the eTT or LMa will be reconnected to the circuit and patient ventilated with 100% o2 for 5 minutes.

The study may be stopped when either of the following conditions is met:
* Data recording has reached the minimum 5 minute mark after patient has been reconnected to the circuit following the controlled desaturation; the data collection is considered complete at this point.
* or if the patient shows signs of cardiac instability (ectopic beats, arrhythmia or hypotension) at any point during the study; the data collection is considered incomplete and the subject will be withdrawn from the study.

Morphometric and demographic characteristics (including surgical procedure diagnoses), airway assessment and anesthetic information will be recorded.
* Hemodynamic measurements (blood pressure, heart rate) before and at one-minute intervals for ten minutes started with laryngoscopy will be recorded from the automatic anesthetic record (ePiC).
* Time to intubation: from the start of mask ventilation until the endotracheal tube is advanced past the vocal cords and a Co2 trace is obtained on the capnograph
-time to 99% saturation: time from the beginning of mask ventilation until 99% saturation is measured
-time to 96% saturation: from the confirmation of the eTT until 96% is measured.
* non-invasive oxygen saturation (Spo2%) will be measured continuously using Masimo Radical 7 (Masimo Corporation,) and recorded at 1sec intervals using a laptop computer with data collection software.

Data will be collected from subjects and sent to the sponsor; our site will not be involved in any data analysis. as Masimo is preparing to develop a proprietary algorithm to assess the oxygen Reserve index, neither the data nor the analysis will be disclosed to our study team.

Participant Eligibility

* Children scheduled for surgical procedures under general anesthesia, where the airway will be controlled with either an endotracheal tube (ETT) or laryngeal mask airway (LMA).

* Patient age 1-17 years

* American Society of Anesthesiology physical status I, II, or III.