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

NCT02860143 | Completed DMC

• 1 other identifier: 2014P001522
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

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

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparison of Respiratory Rate measurement by Respiratory Volume Monitor and Capnography

  Starting approximately 10 min prior to colonoscopy and continuing until end of colonoscopy (average time: 45-60 minutes)

Study Arms (1)

studying ventilation during sedation

Comparing ventilation during sedation with capnography

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02090, United States

Location

Study Officials

• Bhavani Kodali, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: August 9, 2016
• Study Start: March 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: January 18, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)