Trial record 5 of 281 for:    Open Studies | "Poisoning"

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

This study is currently recruiting participants.
Verified May 2013 by University Hospital, Toulouse
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01861262
First received: May 21, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted
  Purpose

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 Intervention
Drug Poisoning
Device: Measurement of StO2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • StO2 performance measured to identify hemodynamic failure. [ Time Frame: Outcome measure is assessed during three hours after the admission to the emergency department. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • StO2 distribution [ Time Frame: Outcome measure is assessed during three hours after the admission to the emergency department. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 263
Study Start Date: April 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women over 18,
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01861262

Contacts
Contact: Emilie DEHOURS, MD 05 67 69 16 75 ext 33 dehours.e@chu-toulouse.fr
Contact: Vanessa HOUZE-CERFON, CRA 05 67 69 16 02 ext 33 houze-cerfon.v@chu-toulouse.fr

Locations
France
University Hospital of Toulouse Recruiting
Toulouse, Midi-Pyrenees, France, 31059
Contact: Emilie DEHOURS, MD    05 67 69 16 75 ext 33    dehours.e@chu-toulouse.fr   
Contact: Vanessa HOUZE-CERFON, CRA    05 67 69 16 02 ext 33    houze-cerfon.v@chu-toulouse.fr   
Principal Investigator: Emilie DEHOURS, MD         
Sub-Investigator: Dominique LAUQUE, MD         
Sub-Investigator: Sandrine CHARPENTIER, MD         
Sub-Investigator: Cédric BELLARD, MD         
Sub-Investigator: Nathalie LECOULES, MD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Emilie DEHOURS, MD University Hospital, Toulouse
  More Information

Publications:
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01861262     History of Changes
Other Study ID Numbers: 12 506 03, HAO 2012
Study First Received: May 21, 2013
Last Updated: May 21, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Toulouse:
emergency
drug poisoning
StO2 measurement
blood pressure
hemodynamic failure

Additional relevant MeSH terms:
Drug Toxicity
Emergencies
Poisoning
Substance-Related Disorders
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 22, 2014