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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02931448
Other study ID # MAS-CO
Secondary ID
Status Withdrawn
Phase
First received
Last updated

Study information

Verified date April 2020
Source Poitiers University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In France, the carbon monoxide is one of the first causes of the accidental poisonings with approximately 8000 cases a year, among which 500 deaths.

The severe forms are translated by neurological disorders even a coma or the death straight away. The more insidious forms with a little carboxyhémoglobine level give rise to frustrate clinical pictures, mimicking flu or intestinal syndromes. The syndrome post--intervallaire corresponds to the appearance of remote neuropsychiatric disorders of the poisoning. Its appearance and its gravity are not correlated in the gravity of the initial poisoning, however the precocity of the treatment tends to decrease its frequency.

Carbon monoxide elimination is made under unchanged form in the expired air. In a spontaneous way, the half-life in ambient air is of the order of 4 hours. In ventilation in isobaric pure oxygen, the half-life is shortened at 80 minutes and in hyperbaric oxygen at 23 minutes.

This imposes a fast diagnosis for two reasons:

- For poisonings with low level, the more the investigators wait to measure the carboxyhémoglobine (HBCO), the more they risk not to detect it.

- The oxygen therapy decreases the duration of the poisoning and thus the tissular suffering.

Actually the risk is important to pass next to the diagnosis and to let leave a patient without adapted care and without technical intervention to eliminate the source of the poisoning.

Presently, to make the diagnosis, the investigators possess the analysis of the blood HbCO by realization of gas of the venous blood, which are taken in emergencies, but very often a few hours after the end of the exposure at the source of poisoning, what is translated by a disappearance of the symptoms and an underestimate of the initial blood HbCO. Since 2005, MASIMO laboratory commercialize a pulse carboxymètre, the RAD 57, which allows to estimate the carboxyhémoglobinémie in a not invasive way.

Lot of studies showed the interest of its use in the early screening of carbon monoxide poisonings, allowing a faster dosage of the blood HbCO, and thus an also faster adapted care.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

Patients over 18 years old consult in ED for :

- cephalalgia

- syncope

- weakness

- nausea

- vomiting

- asthenia

Exclusion Criteria:

- temperature over 38.5 °C

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Dosage of the blood HbCO thanks to the carboxymeter MASIMO RAD 57


Locations

Country Name City State
France Poitiers Universitary Hospital Poitiers

Sponsors (1)

Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of poisoning carbon monoxide confirmed up to 24 hours
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