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Respiration Rate Monitoring During Transitions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01881269
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : November 6, 2013
Information provided by (Responsible Party):
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.

Condition or disease
Focus of the Study is Measuring Respiratory Rate

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Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Respiration Rate Monitoring During Transitions From Spontaneous to Controlled Ventilation
Study Start Date : June 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : September 2013

No treatment
No treatment, prospective observational

Primary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Volunteer subjects from a hospital population, who are scheduled to undergo surgery requiring general anesthesia

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01881269

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United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Medtronic - MITG
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Principal Investigator: Joshua Lumbley, MD The Ohio State University Wexner Medical Center

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Responsible Party: Medtronic - MITG Identifier: NCT01881269     History of Changes
Other Study ID Numbers: COVMOPR0409
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: November 2013