Respiration Rate Monitoring During Transitions

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

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.

Study Overview

• Status: Completed
• Conditions: Focus of the Study is Measuring Respiratory Rate

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Volunteer subjects from a hospital population, who are scheduled to undergo surgery requiring general anesthesia

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
No treatment; No treatment, prospective observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to report a Respiration Rate value after 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)	1 - 3 minutes after the initiation of controlled ventilation

Collaborators and Investigators

• Sponsor: Medtronic - MITG

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): September 1, 2013

Study Registration Dates

• First Submitted: June 17, 2013
• First Submitted That Met QC Criteria: June 17, 2013
• First Posted (ESTIMATE): June 19, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): November 6, 2013
• Last Update Submitted That Met QC Criteria: November 4, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: COVMOPR0409