Evaluating the Accuracy of the ExSpiron Respiratory Device in Surgical Patients

Study ID
STU 062012-037

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Parkland Health & Hospital System

Contact
Humair Rana
214-590-8221
humair.rana@utsouthwestern.edu

Principal Investigator
Humair Rana

Summary

1. Study Design: This is a non-randomized, observational study that will evaluate the efficacy of a novel device. The ExSpiron respiratory monitor is a device that measures impedance pneumography via electrodes placed on the thorax and uses proprietary algorithms to convert this into real time minute ventilation data, including tidal volume and respiratory rate/pattern. We intend to apply this device to 100 surgical patients in order to compare calculated respiratory values from the device to collected values from the mechanical ventilator during surgery and from spirometer values obtained in the PACU.
All patients who consent to study and fit inclusion/exclusion criteria will have electrodes applied to thorax (the system uses two disposable multi-electrode strips, one attached to midsternum and one to right mid-axillary line) prior to surgery to allow for baseline data collection. Patients will also be instructed on the use of spirometry and baseline measurements of tidal volume and vital capacity will be obtained with the spirometer prior to surgery. The ExSpiron device will continue to collect respiratory data through surgery. Data regarding ventilator values (tidal volume, respiratory rate) will be collected from the electronic medical record for analysis. In addition, patients will continue to be monitored with the ExSpiron monitor for up to one hour after surgery in the PACU (patients will be transferred to hospital floor or day surgery area per normal PACU criteria). During this time, patients will be asked to use the same spirometer to measure tidal volume and vital capacity twice during this time period (at 30min and 60min after PACU entrance). If the patient is still intubated in the PACU, data will be collected at the same time intervals after extubation if within two hours of PACU entrance. Values will be recorded on a collection sheet and will be used to correlate with device values after the study is completed.
The patient[Right Quote]s clinical care will not be affected by device use and device measurements will not be used for any clinical decisions. Patient information will be collected retrospectively regarding the patient[Right Quote]s demographics, height, weight, any relevant pulmonary medical or surgical history and complications (e.g. reintubation) from the electronic medical record

Participant Eligibility

1. Any patient having surgery at Parkland Hospital between the age of 18 and 99 years old requiring general anesthesia.