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

Respiratory Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02336022
• Other study ID #: IRB-P00015003
• Status: Completed
• Phase: N/A
• First received: December 15, 2014
• Last updated: July 26, 2016
• Start date: March 2015
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 17 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Respiratory Complications

Intervention

Device:
• Respiratory Motion Inc

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Boston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory rate accurately measured by the ExSpiron monitor during controlled ventilation.		intraoperative	No
Primary	Tidal Volume accurately measured by the ExSpiron monitor during controlled ventilation.		intraoperative	No
Primary	Minute ventilation accurately measured by the ExSpiron monitor during controlled ventilation.		intraoperative	No