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Evaluation of Non-Invasive Respiratory Volume Monitor

NCT03039881 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2019-01-09

No results posted yet for this study

Summary

This observational study investigates the validity and utility of a new, non-significant risk, FDA approved respiratory monitor, ExSpiron, in the perioperative course of patients undergoing elective surgery under general anesthesia. The study patients will be monitored before, during and after surgery, in post-anaesthesia care unit (PACU) and recovery room for the first post-operative night. The physiologic data will not be used or influence the standard of care for subjects. It is anticipated that this monitor may be able to improve perioperative care in the future.

Conditions

  • Monitoring for Low Minute Ventilation Post Surgery

Interventions

DEVICE

Non-Invasive Respiratory Volume Monitor

The device requires the application of a monitoring PadSets to the patient's skin similar to EKG electrodes and, as such, poses minimal risk.

Sponsors & Collaborators

  • Respiratory Motion, Inc.

    collaborator INDUSTRY

  • Tufts Medical Center

    lead OTHER

Principal Investigators

  • Iwona Bonney, PhD · Tufts Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-09
Primary Completion
2019-01-08
Completion
2019-01-08
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03039881 on ClinicalTrials.gov