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

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02860143
• Other study ID #: 2014P001522
• Status: Completed
• Phase: N/A
• First received: July 28, 2015
• Last updated: January 16, 2018
• Start date: March 2015
• Est. completion date: June 2017

Study information

• Verified date: January 2018
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colonoscopy

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)