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Clinical Trials/NCT02336022
NCT02336022
Completed
Not Applicable

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

Boston Children's Hospital1 site in 1 country90 target enrollmentMarch 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Complications
Sponsor
Boston Children's Hospital
Enrollment
90
Locations
1
Primary Endpoint
Minute ventilation accurately measured by the ExSpiron monitor during controlled ventilation.
Status
Completed
Last Updated
9 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
May 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Viviane Nasr

Anesthesiology

Boston Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • pediatric patients between the ages of 1 year and 17 years
  • ASA status of 1-3
  • scheduled to undergo a procedure with general anesthesia at Boston Children's Hospital

Exclusion Criteria

  • Patients undergoing an emergency procedure or a
  • patients undergoing a procedure where the study monitor will interfere with the surgical procedure site or standard of care
  • preexisting respiratory disease
  • muscular disease affecting the respiratory system

Outcomes

Primary Outcomes

Minute ventilation accurately measured by the ExSpiron monitor during controlled ventilation.

Time Frame: intraoperative

Respiratory rate accurately measured by the ExSpiron monitor during controlled ventilation.

Time Frame: intraoperative

Tidal Volume accurately measured by the ExSpiron monitor during controlled ventilation.

Time Frame: intraoperative

Study Sites (1)

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