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

NCT ID: NCT01861262

Last Updated: 2019-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-02-28

Brief Summary

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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

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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.

Conditions

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Drug Poisoning

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Measurement of StO2

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emilie DEHOURS, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hospital of Toulouse

Toulouse, Midi-Pyrenees, France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 9183946 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 17215732 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10622398 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12768125 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15824660 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17572876 (View on PubMed)

Other Identifiers

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12 506 03

Identifier Type: -

Identifier Source: org_study_id

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