Clinical trial NCT01861262: StO2 Performance Measured on Admission to the Emergency Department in the Assessment of Drug Poisoning
Official title: Percentage of Oxygen Saturation of Haemoglobin in Tissues (StO2) Performance Measured on Admission to the Emergency Department in the Assessment of Drug Poisoning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Poisoning
Keywords: emergency
drug poisoning
StO2 measurement
blood pressure
hemodynamic failure
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2013-05-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: StO2 performance measured to identify hemodynamic failure.
timeFrame: Outcome measure is assessed during three hours after the admission to the emergency department.
Secondary outcomes:
measure: StO2 distribution
timeFrame: Outcome measure is assessed during three hours after the admission to the emergency department.
measure: StO2 threshold value to predict the onset of hemodynamic failure
timeFrame: Outcome measure is assessed during three hours after the admission to the emergency department.
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
state: Midi-Pyrenees
Study officials:
affiliation: University Hospital, Toulouse
name: Emilie DEHOURS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lambert H, Manel J, Bellou A, el Kouch S. [Morbidity and mortality from acute drug poisoning in France]. Rev Prat. 1997 Apr 1;47(7):716-20. French.
citation: F.Adnet, S.Atout, M. Galinski. Evolution des intoxications médicamenteuses volontaires en France, 2005, Société de réanimation de langue française
citation: Cohn SM, Nathens AB, Moore FA, Rhee P, Puyana JC, Moore EE, Beilman GJ; StO2 in Trauma Patients Trial Investigators. Tissue oxygen saturation predicts the development of organ dysfunction during traumatic shock resuscitation. J Trauma. 2007 Jan;62(1):44-54; discussion 54-5. doi: 10.1097/TA.0b013e31802eb817.
citation: Reducing the severity of road injuries through post impact care. European Transport Safety Council. Eur J Emerg Med. 1999 Sep;6(3):271-4. doi: 10.1097/00063110-199909000-00020. No abstract available.
citation: Cohn SM, Crookes BA, Proctor KG. Near-infrared spectroscopy in resuscitation. J Trauma. 2003 May;54(5 Suppl):S199-202. doi: 10.1097/01.TA.0000047225.53051.7C. No abstract available.
citation: Crookes BA, Cohn SM, Bloch S, Amortegui J, Manning R, Li P, Proctor MS, Hallal A, Blackbourne LH, Benjamin R, Soffer D, Habib F, Schulman CI, Duncan R, Proctor KG. Can near-infrared spectroscopy identify the severity of shock in trauma patients? J Trauma. 2005 Apr;58(4):806-13; discussion 813-6. doi: 10.1097/01.ta.0000158269.68409.1c.
citation: Creteur J, Carollo T, Soldati G, Buchele G, De Backer D, Vincent JL. The prognostic value of muscle StO2 in septic patients. Intensive Care Med. 2007 Sep;33(9):1549-56. doi: 10.1007/s00134-007-0739-3. Epub 2007 Jun 16.