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Completed

NCT Number: NCT01881269

Respiration Rate Monitoring During Transitions

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.

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Key information

Conditions

Focus of the Study is Measuring Respiratory Rate

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 19, 2013
Registry last updated
Nov 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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