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

Primary Purpose

Drug Poisoning

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Measurement of StO2

About this trial

This is an interventional diagnostic trial for Drug Poisoning focused on measuring emergency, drug poisoning, StO2 measurement, blood pressure, hemodynamic failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital of Toulouse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Measurement of StO2

Arm 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.

Outcomes

Primary Outcome Measures

StO2 performance measured to identify hemodynamic failure.

Secondary Outcome Measures

StO2 distribution

StO2 threshold value to predict the onset of hemodynamic failure

Full Information

NCT ID

NCT01861262

First Posted

May 21, 2013

Last Updated

July 12, 2019

Sponsor

University Hospital, Toulouse

1. Study Identification

Unique Protocol Identification Number

NCT01861262

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Toulouse

4. Oversight

Data Monitoring Committee

5. 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.

Detailed Description

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Drug Poisoning

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Measurement of StO2

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Measurement of StO2

Intervention Description

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

StO2 distribution

Time Frame

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

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emilie DEHOURS, MD

Organizational Affiliation

University Hospital, Toulouse

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of Toulouse

City

Toulouse

State/Province

Midi-Pyrenees

ZIP/Postal Code

31059

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

9183946

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.

Results Reference

background

Citation

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

Results Reference

background

PubMed Identifier

17215732

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.

Results Reference

background

PubMed Identifier

10622398

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.

Results Reference

background

PubMed Identifier

12768125

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.

Results Reference

background

PubMed Identifier

15824660

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.

Results Reference

background

PubMed Identifier

17572876

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.

Results Reference

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

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