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



Status:Completed
Healthy:No
Age Range:1 - 17
Updated:7/28/2016
Start Date:March 2015
End Date:May 2016

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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.


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
We found this trial at
1
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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