OverdoseNCT02101424
Monitoring of Overdose Patients With and Without Supplemental Oxygen in the Emergency Department
An observational study of Overdose, run by Hennepin Healthcare Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overdose
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the emergency department at an urban county hospital.
Who may be able to join
- Airway is being monitored as a result of overdose
Who cannot join
- Under 18 years old
- Unable to give informed consent at baseline
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
About this study
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
- Medical subject headings
- Drug Overdose, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Overdose | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 hours
Pulse oximetry
recorded every 5 minutes and at the time of clinical interventions
Measured: 4 hours
End tidal CO2
recorded every 5 minutes and at the time of any clinical intervention
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startMay 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverdoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James R Miner, MD, Principal investigator, Hennepin Healthcare Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101424
- Sponsor's protocol ID
- 10-3179
- Status last verified
- Oct 2014
- First submitted
- 24 Oct 2013
- Last updated
- 24 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Overdose Patients With and Without Supplemental Oxygen in the Emergency Department
- ClinicalTrials.gov ID
- NCT02101424
- Acronym / sponsor ID
- 10-3179
- Conditions
- Overdose
- Keywords
- Overdose, Emergency Department, Supplemental Oxygen, Pulse Oximeter, Capnography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overdose | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the emergency department at an urban county hospital.
Key inclusion criteria (1 listed)
- Airway is being monitored as a result of overdose
Key exclusion criteria (3 listed)
- Under 18 years old
- Unable to give informed consent at baseline
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Airway Interventions Performed by ED Staff
Time frame: 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.
Pulse oximetry
Time frame: 4 hours
recorded every 5 minutes and at the time of clinical interventions
End tidal CO2
Time frame: 4 hours
recorded every 5 minutes and at the time of any clinical intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James R Miner, MD principal investigator
Hennepin Healthcare Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overdose, run by Hennepin Healthcare Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Airway Interventions Performed by ED Staff (time frame: 4 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2014.