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

NCT ID: NCT02860143

Last Updated: 2018-01-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 95 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-06-30

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

studying ventilation during sedation

Comparing ventilation during sedation with capnography

No interventions assigned to this group

Eligibility Criteria

Exclusion Criteria

Criteria: patients not able to give informed consent, Inability to place the PadSets on the thorax. Existence of an active implanted neurostimulator.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bhavani Shankar Kodali

Staff Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bhavani Kodali, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2014P001522

Identifier Type: -

Identifier Source: org_study_id