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

NCT02336022 | Completed

• 1 other identifier: IRB-P00015003
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Complications

Keywords

general anesthesia

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

Respiratory Motion Inc DEVICE

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02116, United States

Location

Study Officials

• Viviane Nasr

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: January 12, 2015
• Study Start: March 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 27, 2016

Record last verified: 2016-07

Locations

US (1)