Status:
COMPLETED
Respiration Rate Monitoring During Transitions
Lead Sponsor:
Medtronic - MITG
Conditions:
Focus of the Study is Measuring Respiratory Rate
Eligibility:
All Genders
18-65 years
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 spo...
Eligibility Criteria
Inclusion
- 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 3.
- Body mass index (BMI) ≤30 kg/m2.
- Subject is willing and able to provide written consent.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01881269
Start Date
June 1 2013
End Date
September 1 2013
Last Update
November 6 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210