Assessment of Respiration Rate Monitoring During Transitions From Spontaneous to Controlled Ventilation

Medtronic - MITG1 site in 1 country27 target enrollmentJune 2013

ConditionsFocus of the Study is Measuring Respiratory Rate

Overview

Phase: N/A
Intervention: Not specified
Conditions: Focus of the Study is Measuring Respiratory Rate
Sponsor: Medtronic - MITG
Enrollment: 27
Locations: 1
Primary Endpoint: Time to report a Respiration Rate value after initiation of controlled ventilation
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the performance of the software that calculates respiration rate for the study pulse oximetry monitoring system during transitions of ventilation type from spontaneous breathing to controlled ventilation.

Registry

clinicaltrials.gov

Start Date

June 2013

End Date

September 2013

Last Updated

12 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Medtronic - MITG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Be undergoing a procedure with planned general anesthesia involving placement of an endotracheal tube or laryngeal mask airway following induction of anesthesia.
•American Society of Anesthesiologists physical status classification (ASA) Status 1, 2 or
•Body mass index (BMI) ≤30 kg/m
•Subject is willing and able to provide written consent.

Exclusion Criteria

•Female subjects of child-bearing potential with a positive pregnancy test or an absence of documented non-childbearing status in the medical history records.
•Female subjects who are currently lactating and breastfeeding.
•Subjects with any evidence of potential difficulty in mask ventilation and/or tracheal intubation.
•Subject has an abnormality that may prevent proper application of the device/sensors.
•Subject is in atrial fibrillation.
•Subject has a documented history of frequent premature ventricular contractions (PVCs), defined as greater than 3 in 30 seconds or greater than 6 in 60 seconds.
•Subject has an implanted pacemaker.
•Subjects with non-sinus rhythm, frequent premature ventricular complexes (\> 5 min), or abnormal PR, QRS, or QT intervals on screening ECG.
•Subjects with artificial finger nails.

Outcomes

Primary Outcomes

Time to report a Respiration Rate value after initiation of controlled ventilation

Time Frame: 1 - 3 minutes after the initiation of controlled ventilation

Time (in seconds) for the software to report a Respiration Rate value within one breath per minute of the controlled ventilation rate after placement of the airway device (endotracheal tube or laryngeal mask airway)