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

Overdose Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101424
• Other study ID #: 10-3179
• Status: Completed
• Phase: N/A
• First received: October 24, 2013
• Last updated: October 23, 2014
• Start date: May 2010
• Est. completion date: December 2013

Study information

• Verified date: October 2014
• Source: Minneapolis Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Drug Overdose
• Emergencies
• Overdose

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Medical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Pulse oximetry	recorded every 5 minutes and at the time of clinical interventions	4 hours	No
Primary	End tidal CO2	recorded every 5 minutes and at the time of any clinical intervention	4 hours	No