Prognosis of Patients Who Presented With a State of Extreme Agitation.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Emergence Delirium. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assess the 6-month Prognosis of Patients Who Presented With a State of Extreme Agitation: "Excited Delirium Syndrome" AGICOHORT
Overview
The main objective is to assess the 6-month prognosis of patients who presented with extreme agitation in the emergency room. The primary endpoint is the 6-month mortality of agitated patients.
Detailed description
Emergency services are confronted with emergency situations characterized by patients who are victims of significant agitation, in particular states of extreme agitation "excited delirium syndrome", which is constantly increasing and which seems to be associated with morbidity and mortality not negligible.
Patients meeting the inclusion and non-inclusion criteria are included on admission to the emergency room.
An evaluation at H1 and at the end of hospitalization is carried out. The patient is contacted by telephone at M1, M3 and M6.
The inclusion period is 24 months The duration of participation (treatment + follow-up) is 6 months The total duration is 30 months.
The research is multicentric and national with the participation of 8 centres.
Primary outcome measures
- Number of deceased patients [Time frame: 6 months]
Secondary outcome measures (12)
- Assess the characteristics of agitated patients regarding the age [Time frame: 6 months]
- Assess the characteristics of agitated patients regarding the gender [Time frame: 6 months]
- Assess the characteristics of agitated patients regarding the mode of arrival in the emergency room [Time frame: 6 months]
- Assess the characteristics of agitated patients regarding medical history [Time frame: 6 months]
- Assess the characteristics of agitated patients regarding vital signs (blood pressure) [Time frame: 6 months]
- Assess the characteristics of agitated patients regarding vital signs (oxygen saturation) [Time frame: 6 months]
- Assess the characteristics of agitated patients regarding vital signs (heart rate) [Time frame: 6 months]
- Assess the characteristics of agitated patients regarding vital signs (respiratory rate) [Time frame: 6 months]
- Assess the characteristics of agitated patients regarding vital signs (temperature) [Time frame: 6 months]
- Assess the characteristics of agitated patients regarding vital signs (Glasgow coma scale) [Time frame: 6 months]
- Assess the characteristics of agitated patients regarding vital signs (Corrected QT interval on electrocardiogram) [Time frame: 6 months]
- Assess the characteristics of agitated patients regarding patient biology (blood ionogram) [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Agitated patient with the presence of three major criteria, namely,
- restlessness
- insensitivity to pain
- tachypnea (fr>20)
and the presence of a minor criterion among
- sweating
- skin hyperthermia
- non-compliance with law enforcement
- tirelessness
- unusual strength
- inappropriate clothing, nudity
Exclusion criteria
- patient age < 18 years
- head trauma
- pregnancy
- detained
- other obvious causes of pain leading to restlessness (renal colic, migraines, etc.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Avicenne Hospital - Aphp — Bobigny
Identifiers
NCT: NCT05632419 · P220382