NCT02860143

Assessment of Ventilation Using Respiratory Volume Monitor Compared to Capnography During Intravenous Sedation

Assessment of Ventilation Using Respiratory Volume Monitor During Sedation With Intravenous Propofol as Compared to Capnography in Patients Receiving Intravenous Sedation.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 95 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

A. Determine if Respiratory Volume Monitor (RVM) can be used during procedural sedation to adequately monitor patient's respiratory status as compared to capnograph Aims B. Compare the time of capture of respiratory events (depression, arrest, etc…) on both the RVM and the capnograph C. Compare the incidence of missing or poor quality readings between the RVM and the capnograph D. Compare RR readings between the RVM and the capnograph (during periods with adequate data quality on both devices) E. If RMV can identify respiratory obstruction. Capnography

Detailed description

Rationale for Proposed Research: Continuous respiratory monitoring using the ExSpiron System will be particularly beneficial to patients receiving intravenous propofol breathing spontaneously with natural airway. Assessment and management of respiratory function and early intervention when indicated is a multifaceted, complex task often complicated by the unavailability of a cohesive and continuous monitoring system to guide clinical decisions. The ExSpiron system is designed for these patients and is intended to address some of the limitations of the current generation of hospital monitors and to provide healthcare providers with continuous real-time data regarding the patient's respiratory status. Recent RVM data has shown that stratification of patients based on the MV % of predicted, prior to opioid dosing has made it possible to identify patients who are at risk for further decrease in MV and opioid-induced respiratory depression (OIRD). 1. In the spontaneously breathing, non-ventilated patient, current monitoring devices do not provide continuous, objective non-invasive, continuous real time information of important respiratory parameters such as TV, MV and RR. 2. Current monitoring of non-intubated patients mostly relies on oximetry data, subjective clinical assessment and occasionally EtCO2 measurements. In appropriate clinical settings, the ExSpiron system can provide direct quantitative measure of ventilation parameters for use in clinical assessment and trend prediction as well as response to medications and other interventions.

Conditions

• Colonoscopy

Timeline

• Start date: 2015-03-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2016-08-09
• Last updated: 2018-01-18

Locations

1 site across 1 country: United States