Respiration Rate Monitoring During Transitions
Completed
Conditions studied: Focus of the Study is Measuring Respiratory Rate
In brief
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.
Key facts
- Study ID
- NCT01881269
- Run by
- Medtronic - MITG
- People needed
- 27
- Starts
- 2013-06-01
- Expected to finish
- 2013-09-01
- Last updated by the study team
- 2013-11-06
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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