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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Respiratory Complications

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02116, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Respiratory Motion Inc

Device

Primary outcomes

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

Time frame: intraoperative

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Jan 12, 2015
Registry last updated: Jul 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed