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Completed

NCT Number: NCT01861262

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.

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Key information

Conditions

Drug Poisoning Chemically-Induced Disorders Disease Attributes Drug-Related Side Effects and Adverse Reactions Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Toulouse

Toulouse, Midi-Pyrenees, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measurement of StO2

Device

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.

Primary outcomes

  1. StO2 performance measured to identify hemodynamic failure.

    Time frame: Outcome measure is assessed during three hours after the admission to the emergency department.

Secondary outcomes

  1. StO2 distribution

    Time frame: Outcome measure is assessed during three hours after the admission to the emergency department.

  2. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: IMACS

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
May 23, 2013
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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