Assessment of Ventilation Using Respiratory Volume Monitor Compared to Capnography During Intravenous Sedation
Status: | Completed |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 20 - Any |
Updated: | 1/20/2018 |
Start Date: | March 2015 |
End Date: | June 2017 |
Assessment of Ventilation Using Respiratory Volume Monitor During Sedation With Intravenous Propofol as Compared to Capnography in Patients Receiving Intravenous Sedation.
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
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
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.
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.
Inclusion Criteria:
Inclusion Criteria: patient's ≥ 20 years of age receiving intravenous sedation, or
intravenous general anesthesia with propofol.
Exclusion Criteria:
Criteria: patients not able to give informed consent, Inability to place the PadSets on the
thorax. Existence of an active implanted neurostimulator.
We found this trial at
1
site
75 Francis street
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Bhavani Kodali, MD
Phone: 617-525-8449
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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