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

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.

Study Overview

• Status: Completed
• Conditions: Overdose

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the emergency department at an urban county hospital.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Overdose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Airway Interventions Performed by ED Staff	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.	4 hours
Pulse oximetry	recorded every 5 minutes and at the time of clinical interventions	4 hours
End tidal CO2	recorded every 5 minutes and at the time of any clinical intervention	4 hours

Collaborators and Investigators

• Sponsor: Hennepin Healthcare Research Institute

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: October 24, 2013
• First Submitted That Met QC Criteria: April 1, 2014
• First Posted (ESTIMATE): April 2, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): October 24, 2014
• Last Update Submitted That Met QC Criteria: October 23, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Emergency Department; Capnography; Pulse Oximeter; Overdose; Supplemental Oxygen
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Disease Attributes; Emergencies; Drug Overdose
• Other Study ID Numbers: 10-3179