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.

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

Study Overview

• Status: Completed
• Conditions: Colonoscopy

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.

• Study Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02090
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

50 patients receiving intravenous propofol for sedation, or general anesthesia with natural airway and breathing spontaneously will be recruited and will give written informed consent. The RVM data collection will end when the patient is discharged from the operating room.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
studying ventilation during sedation; Comparing ventilation during sedation with capnography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in minute ventilation, tidal volume, and end-tidal carbon dioxide following propofol	Minute ventilation (MV) and tidal volume (TV) measured by the Respiratory Volume Monitor will be reported as percent of baseline established during normal breathing prior to sedation. The percent decrease in MV and TV following propofol will be compared to changes in end-tidal CO2 measured by capnography. The amount of time between propofol doses and changes in MV and TV and EtCO2 will be quantified and compared.	Starting approximately 10 min prior to colonoscopy and continuing until end of colonoscopy (average time: 45-60 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Respiratory Rate measurement by Respiratory Volume Monitor and Capnography	Respiratory rate measurements from the respiratory volume monitor and capnography will be compared. The percent time that a respiratory rate reading is available will be quantified and compared.	Starting approximately 10 min prior to colonoscopy and continuing until end of colonoscopy (average time: 45-60 minutes)

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (ACTUAL): June 1, 2017
• Study Completion (ACTUAL): June 1, 2017

Study Registration Dates

• First Submitted: July 28, 2015
• First Submitted That Met QC Criteria: August 5, 2016
• First Posted (ESTIMATE): August 9, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2018
• Last Update Submitted That Met QC Criteria: January 16, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2014P001522

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO