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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02336022

Enrollment

Registered

2015-01-12

Start date

2015-03-31

Completion date

2016-05-31

Last updated

2016-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Complications

Keywords

general anesthesia

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.

Interventions

DEVICERespiratory Motion Inc

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026