Prognosis of Patients Who Presented With a State of Extreme Agitation.
- Conditions
- Emergence Delirium
- Registration Number
- NCT05632419
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 608
- 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
- patient age < 18 years
- head trauma
- pregnancy
- detained
- other obvious causes of pain leading to restlessness (renal colic, migraines, etc.)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of deceased patients 6 months The 6-month prognosis of patients who presented with extreme agitation in the emergency room.
- Secondary Outcome Measures
Name Time Method Characterize the management of patients in extreme agitation according to initial pharmacological treatments administered 6 months Initial pharmacological treatments administered
Assess the characteristics of agitated patients regarding the age 6 months Age
Assess the characteristics of agitated patients regarding medical history 6 months Medical history
Assess the characteristics of agitated patients regarding vital signs (oxygen saturation) 6 months Oxygen saturation
Assess the characteristics of agitated patients regarding vital signs (heart rate) 6 months Heart rate
Assess the characteristics of agitated patients regarding vital signs (Corrected QT interval on electrocardiogram) 6 months Corrected QT interval (QTc)
Assess the characteristics of agitated patients regarding patient biology (blood ionogram) 6 months Blood ionogram
Assess the characteristics of agitated patients regarding patient biology (urine and blood toxins) 6 months Urine and blood toxins
Assess the characteristics of agitated patients regarding patient biology 6 months Arterial blood gas
Assess the characteristics of agitated patients regarding patient biology (Complete blood count) 6 months Complete blood count (CBC)
Assess the characteristics of agitated patients regarding agitation (BARS) 6 months Agitation assessment scale (Behavioural Activity Rating Scale, BARS) (1 = worse outcome to 7 = worse outcome , 4 is the better outcome)
Assess the characteristics of agitated patients regarding agitation (CGI S) 6 months Agitation assessment scale (Clinical Global Impression Severity or CGI S, 0 = Not evaluated to 7 = worse outcome)
Assess the characteristics of agitated patients regarding the gender 6 months Gender
Assess the characteristics of agitated patients regarding the mode of arrival in the emergency room 6 months Mode of arrival in the emergency room
Assess the characteristics of agitated patients regarding vital signs (temperature) 6 months Temperature
Assess the characteristics of agitated patients regarding vital signs (Glasgow coma scale) 6 months Glasgow coma scale (The GCS is scored between 3 and 15, 3 being the worst and 15 the best).
Assess the characteristics of agitated patients regarding vital signs (blood pressure) 6 months Blood pressure
Assess the characteristics of agitated patients regarding vital signs (respiratory rate) 6 months Respiratory rate
Assess the characteristics of agitated patients regarding agitation (RASS) 6 months Agitation assessment scale (Richmond Agitation Sedation Scale, RASS) (-5 = worse outcome to +4 = worse outcome, 0 is the better outcome)
Characterize the etiologies of this syndrome (organic, psychiatric or iatrogenic) 6 months Organic
* medical background,
* somatic etiology research with intrinsic imputability criteria (chronological and semiological) and extrinsic (literature)
* capillary blood glucose, temperature, Glasgow, electrocardiogram
* blood ionogram, arterial blood gas, blood count Iatrogenic
* analytical by means of a urinary and blood toxin screening for recent consumptions of psychoactive substances
* search the treatment of the patient psychiatric
* clinical observations obtained during consultationCharacterize the management of patients in extreme agitation according to the need for physical restraints 6 months Need for physical restraints
Characterize the management of patients in extreme agitation according to the eed for upper airway protection with intubation 6 months Need for upper airway protection with intubation
Assess the efficacy of the pharmacological treatments administered (GCI S) 6 months According to agitation scale at H1, H2 (Clinical Global Impression Severity or CGI S, 0 = Not evaluated to 7 = worse outcome) and need for other pharmacological treatments
Assess the efficacy of the non-pharmacological treatments administered (RASS) 6 months According to agitation scale at H1, H2 (Richmond Agitation Sedation Scale, RASS) (-5 = worse outcome to +4 = worse outcome, 0 is the better outcome) and need for other non-pharmacological treatments
Assess the efficacy of the non-pharmacological treatments administered (BARS) 6 months According to agitation scale at H1, H2 (Behavioural Activity Rating Scale, BARS) (1 = worse outcome to 7 = worse outcome , 4 is the better outcome) and need for other non-pharmacological treatments
Trial Locations
- Locations (1)
Avicenne Hospital - Aphp
🇫🇷Bobigny, Ile De France, France