Respiration Rate Monitoring During Transitions

Completed

• Conditions: Focus of the Study is Measuring Respiratory Rate

• Registration Number: NCT01881269
• Lead Sponsor: Medtronic - MITG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-06-17
• Study First Posted: 2013-06-19
• Primary Completion: 2013-07
• Study Completion: 2013-09
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-04
• Last Update Posted: 2013-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 3.
• Body mass index (BMI) ≤30 kg/m2.
• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States