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

NCT02101424 | Completed

• 1 other identifier: 10-3179
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Overdose

Keywords

Overdose; Emergency Department; Supplemental Oxygen; Pulse Oximeter; Capnography

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Overdose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Airway is being monitored as a result of overdose

You may not qualify if:

• Under 18 years old
• Unable to give informed consent at baseline
• Prisoners

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

MeSH Terms

Conditions

Drug Overdose; Emergencies

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• James R Miner, MD

  Hennepin Healthcare Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: April 2, 2014
• Study Start: May 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 24, 2014

Record last verified: 2014-10

Locations

US (1)