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

Not Applicable

Completed

• Conditions: Drug Poisoning
• Interventions: Device: Measurement of StO2

• Registration Number: NCT01861262
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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.

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 Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-21
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-23
• Primary Completion: 2013-08
• Study Completion: 2014-02
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-12
• Last Update Posted: 2019-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Measurement of StO2	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital of Toulouse; 🇫🇷 Toulouse, Midi-Pyrenees, France