StO2 Performance Measured on Admission to the Emergency Department in the Assessment of Drug Poisoning (IMACS)

July 12, 2019 updated by: University Hospital, Toulouse

Percentage of Oxygen Saturation of Haemoglobin in Tissues (StO2) Performance Measured on Admission to the Emergency Department in the Assessment of Drug Poisoning

The primary purpose of the protocol is to evaluate the StO2 performance measured at the admission to the emergency department to identify hemodynamic failure at the admission or within the first three hours of monitoring patients with drug poisoning.

The study hypotheses are:

  • The early detection of hypoperfusion by StO2, essential to prevent the development of collapse.
  • To limit hemodynamic failure effects, reduce morbidity and mortality of drug poisoning, hospital stay and cost.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The procedure is a measurement and non-invasive monitoring system of percentage of oxygen saturation of haemoglobin in tissues using infrared technology. The system used in the study is the tissue oxygenation monitor InSpectraTM StO2 Spot Check, Model 300 consisting of a clamp applied to the base of the thumb of the patient.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Midi-Pyrenees
      • Toulouse, Midi-Pyrenees, France, 31059
        • University Hospital of Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • admitted to the emergency department,
  • whose pattern of hospitalization is drug poisoning, defined on data from the patient's interrogation or his family if the patient is not able to answer,
  • Written informed consent signed by the patient or, if he's unable to sign, by a companion,
  • Affiliated to medical insurance

Exclusion Criteria:

  • Patients without thenar eminence or having a disease of the thenar,
  • Refusal to participate in the study,
  • Participation in another biomedical research,
  • Patient under guardianship, trusteeship or judicial protection,
  • Pregnant women or nursing mothers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Measurement of StO2
The procedure is a measurement and non-invasive monitoring system of percentage of oxygen saturation of haemoglobin in tissues using infrared technology. The system used in the study is the tissue oxygenation monitor InSpectraTM StO2 Spot Check, Model 300 consisting of a clamp applied to the base of the thumb of the patient.
Device: Measurement of StO2
The procedure is a measurement and non-invasive monitoring system of percentage of oxygen saturation of haemoglobin in tissues using infrared technology. The system used in the study is the tissue oxygenation monitor InSpectraTM StO2 Spot Check, Model 300 consisting of a clamp applied to the base of the thumb of the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
StO2 performance measured to identify hemodynamic failure.
Time Frame: Outcome measure is assessed during three hours after the admission to the emergency department.
Outcome measure is assessed during three hours after the admission to the emergency department.

Secondary Outcome Measures

Outcome Measure
Time Frame
StO2 distribution
Time Frame: Outcome measure is assessed during three hours after the admission to the emergency department.
Outcome measure is assessed during three hours after the admission to the emergency department.
StO2 threshold value to predict the onset of hemodynamic failure
Time Frame: Outcome measure is assessed during three hours after the admission to the emergency department.
Outcome measure is assessed during three hours after the admission to the emergency department.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Emilie DEHOURS, MD, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

May 21, 2013

First Submitted That Met QC Criteria

May 21, 2013

First Posted (Estimate)

May 23, 2013

Study Record Updates

Last Update Posted (Actual)

July 16, 2019

Last Update Submitted That Met QC Criteria

July 12, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12 506 03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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