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Monitoring of Overdose Patients With and Without Supplemental Oxygen in the Emergency Department

Sponsor
Hennepin Healthcare Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02101424
Collaborator
(none)
300
Enrollment
1
Location
43
Duration (Months)
7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will compare the data from pulse oximeters to capnographers as they are used to monitor patients who are being observed in the Emergency Department for a suspected overdose of alcohol or other drugs. The investigators will compare monitor data from patients who are and are not on supplemental oxygen, the ability of the monitors to predict the occurrence of airway interventions, and to detect ventilator changes noted on the opposing monitor. There will not be any interventions during this study other than the collection of data from the monitors and observation of the care of patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Monitoring of Overdose Patients With and Without Supplemental Oxygen in the Emergency Department
    Study Start Date :
    May 1, 2010
    Actual Primary Completion Date :
    Dec 1, 2013
    Actual Study Completion Date :
    Dec 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Overdose

    Outcome Measures

    Primary Outcome Measures

    1. Airway Interventions Performed by ED Staff [4 hours]

      Addition or increase in supplemental oxygen, stimulation to induce respiration, airway repositioning, bag-valve-mask application, positive pressure ventilation, intubation, airway suctioning, vomiting, medication administration, transfer to a higher level of care.

    2. Pulse oximetry [4 hours]

      recorded every 5 minutes and at the time of clinical interventions

    3. End tidal CO2 [4 hours]

      recorded every 5 minutes and at the time of any clinical intervention

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Airway is being monitored as a result of overdose
    Exclusion Criteria:

    • Under 18 years old

    • Unable to give informed consent at baseline

    • Prisoners

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hennepin County Medical Center Minneapolis Minnesota United States 55415

    Sponsors and Collaborators

    • Hennepin Healthcare Research Institute

    Investigators

    • Principal Investigator: James R Miner, MD, Hennepin Healthcare Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hennepin Healthcare Research Institute
    ClinicalTrials.gov Identifier:
    NCT02101424
    Other Study ID Numbers:
    • 10-3179
    First Posted:
    Apr 2, 2014
    Last Update Posted:
    Oct 24, 2014
    Last Verified:
    Oct 1, 2014
    Keywords provided by Hennepin Healthcare Research Institute
    Overdose
    Emergency Department
    Supplemental Oxygen
    Pulse Oximeter
    Capnography
    Additional relevant MeSH terms:
    Emergencies
    Drug Overdose

    Study Results

    No Results Posted as of Oct 24, 2014