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

• ClinicalTrials.gov Identifier: NCT01861262
• Recruitment Status: Completed
• First Posted: May 23, 2013
• Last Update Posted: July 16, 2019
• Sponsor: University Hospital, Toulouse
• Information provided by (Responsible Party): University Hospital, Toulouse

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Drug Poisoning	Device: Measurement of StO2	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 300 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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 Start Date: April 2013
• Actual Primary Completion Date: August 2013
• Actual Study Completion Date: February 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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. ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

France

University Hospital of Toulouse

Toulouse, Midi-Pyrenees, France, 31059

Sponsors and Collaborators

University Hospital, Toulouse

Investigators

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

More Information

Publications:

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.

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

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.

Reducing the severity of road injuries through post impact care. European Transport Safety Council. Eur J Emerg Med. 1999 Sep;6(3):271-4.

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

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.

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.

• Responsible Party: University Hospital, Toulouse
• ClinicalTrials.gov Identifier: NCT01861262 History of Changes
• Other Study ID Numbers: 12 506 03
• First Posted: May 23, 2013
• Last Update Posted: July 16, 2019
• Last Verified: July 2019

Keywords provided by University Hospital, Toulouse:

emergency; drug poisoning; StO2 measurement; blood pressure; hemodynamic failure

Additional relevant MeSH terms:

Emergencies; Poisoning; Drug-Related Side Effects and Adverse Reactions; Disease Attributes; Pathologic Processes; Chemically-Induced Disorders