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

Drug Poisoning Clinical Trial

— IMACS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01861262
• Other study ID #: 12 506 03
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: February 2014

Study information

• Verified date: July 2019
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Poisoning
• Drug-Related Side Effects and Adverse Reactions
• Emergencies
• Poisoning

Intervention

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.

Locations

Country	Name	City	State
France	University Hospital of Toulouse	Toulouse	Midi-Pyrenees

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (7)

Cohn SM, Crookes BA, Proctor KG. Near-infrared spectroscopy in resuscitation. J Trauma. 2003 May;54(5 Suppl):S199-202. Review. — View 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. — View 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. Epub 2007 Jun 16. — View 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. — View Citation

F.Adnet, S.Atout, M. Galinski. Evolution des intoxications médicamenteuses volontaires en France, 2005, Société de réanimation de langue française

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	StO2 performance measured to identify hemodynamic failure.		Outcome measure is assessed during three hours after the admission to the emergency department.
Secondary	StO2 distribution		Outcome measure is assessed during three hours after the admission to the emergency department.
Secondary	StO2 threshold value to predict the onset of hemodynamic failure		Outcome measure is assessed during three hours after the admission to the emergency department.