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The Evaluation of a Noninvasive Respiratory Monitor in Pediatric Patients Undergoing General Anesthesia

NCT02336022 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2016-07-27

No results posted yet for this study

Summary

Pediatric postoperative patients are at increased risk for post-operative respiratory complications such as hypoventilation. There is no objective measure of early respiratory parameters that would predict respiratory compromise after surgery efficiently in pediatric patients. Current respiratory assessment in non-intubated patients relies on oximetry data, impendence respiratory rate monitor and subjective clinical assessment. Pulse oximetry has been extremely helpful in recognizing oxygen desaturations but it is a late indicator of respiratory decline. New advances in technology and digital signal processing have led to the development of an improved impedance based Respiratory Volume Monitor (RVM). The RVM (ExSpiron™, Respiratory Motion, Inc.; Waltham, MA) has been shown to provide accurate real-time, continuous, non-invasive measurements of tidal volume (TV), minute ventilation (MV) and respiratory rate (RR) mostly in adult patients. The investigators' primary hypothesis is that the non-invasive, impedance-based RVM monitor will accurately reflect TV, RR and MV in pediatric patients.

Conditions

  • Respiratory Complications

Interventions

DEVICE

Respiratory Motion Inc

Sponsors & Collaborators

Principal Investigators

  • Viviane Nasr · Boston Children's Hospital

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT02336022 on ClinicalTrials.gov