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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Complications
• Intervention / Treatment: Device: Respiratory Motion Inc

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02116
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing general anesthesia for surgical procedures at Boston Children's Hospital.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Respiratory rate accurately measured by the ExSpiron monitor during controlled ventilation.	intraoperative
Tidal Volume accurately measured by the ExSpiron monitor during controlled ventilation.	intraoperative
Minute ventilation accurately measured by the ExSpiron monitor during controlled ventilation.	intraoperative

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Viviane Nasr, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: December 15, 2014
• First Submitted That Met QC Criteria: January 9, 2015
• First Posted (Estimate): January 12, 2015

Study Record Updates

• Last Update Posted (Estimate): July 27, 2016
• Last Update Submitted That Met QC Criteria: July 26, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: general anesthesia
• Other Study ID Numbers: IRB-P00015003