Respiration Rate Monitoring During Transitions

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01881269

Enrollment

Registered

2013-06-19

Start date

2013-06-30

Completion date

2013-09-30

Last updated

2013-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focus of the Study is Measuring Respiratory Rate

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

United States

Outcome results