Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04653597 |
Other study ID # |
APHP200013 |
Secondary ID |
2020-A02036-33 |
Status |
Completed |
Phase |
Phase 3
|
First received |
|
Last updated |
|
Start date |
May 16, 2021 |
Est. completion date |
April 12, 2023 |
Study information
Verified date |
July 2023 |
Source |
Assistance Publique - Hôpitaux de Paris |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
A decreased level of consciousness is a common reason for presentation to the emergency
department (ED) and is often the result of intoxication (up to 1% of all ED visits and 3% of
ICU admission). In France, approximately 165 000 poisoned patients are managed each year.
Originally developed in head injured patients, the Glasgow Coma Scale (GCS) is a validated
reproducible score evaluating the level of consciousness: a GCS ≤ 8 is strongly associated
with reduced gag reflex and increased incidence of aspiration pneumonia. Although recommended
for patients with traumatic brain injury and coma, it remains unknown whether the benefit of
an invasive management of airways with sedation, intubation and mechanical ventilation should
be applied to other causes of coma in particular for acute poisoned patients. The
investigator hypothesize that a conservative management with close monitoring without
immediate endotracheal intubation of these patients is effective and associated with less
in-hospital complications (truncated at 28 days) compared to routine practice management (in
which the decision of immediate intubation is left to the discretion of the emergency
physician).
Description:
A decreased level of consciousness is a common reason for presentation to the emergency
department (ED) and is often the result of intoxication (up to 1% of all ED visits and 3% of
intensive care unit (ICU) admission). In France, approximately 165 000 poisoned patients are
managed each year.1 Originally developed in head injured patients, the Glasgow Coma Scale
(GCS) is a validated reproducible score evaluating the level of consciousness - a GCS ≤ 8 is
associated with reduced gag reflex and increased incidence of aspiration pneumonia (with an
adjusted odds ratio of 2.32, 95%CI =1.60 to 3.33). However, whether this risk of aspiration
pneumonia (AP) may be decreased by early intubation is unknown, and no difference in the risk
of AP was reported between patients that were intubated early and patients who were not.
Although it is well established that in trauma patients, a GCS ≤ 8 mandates airway management
by endotracheal intubation, it remains unknown whether this strategy should be applied to
other etiologies of coma, in particular for acute poisoned patients. Tracheal intubation and
mechanical ventilation allow to prevent aspiration pneumonia, to optimize oxygenation and gas
exchange.
Investigators will include patients with a decreased level of consciousness (defined by a GCS
of 8 or less) caused by acute intoxication (alcohol, recreative drugs, or other prescription
drugs (with the exception intoxication with cardiotropic drugs, e.g. beta blockers, calcium
channel inhibitor, angiotensin conversion enzyme)). These patients will be included at the
initial stage of their management: in the ED, or out of hospital with a pre-hospital
emergency physician. Patients with clear proven benefit of intubation will be excluded :
patients in shock, patients with suspicion of brain lesion, seizure related with poisoning,
visualization of regurgitation of gastric content or sign of respiratory distress.
Conservative airway management. Patients will be conservatively managed, i.e. close
monitoring and no intubation and mechanical ventilation unless the patient presents a
clinical event that needs intubation (shock, sign of respiratory distress, visualization of
regurgitation or seizure).
Acute poisoning is a common reason for presentation to the ED or MICU intervention (up to 1%
of all ED visits and 3% of intensive care unit (ICU) admission). These patients are often
intubated (reported rate ranging from 20 to 50% in different cohort studies), when their GCS
is below 8, in order to protect their airways. However there is currently no clear
demonstration of its efficacy in this specific target population, while it is known that
intubation is associated with morbidity and mortality.
Intubated patients need subsequent intensive care unit admission and invasive monitoring, and
this can be associated with increased risk of pulmonary complications, length of
hospital-stay, nosocomial infections and cost. In a context of expenditures control in health
care, appropriate intensive care resource utilization is an important issue. When considering
the increasing demand for intensive care among emergency patients, the importance of health
care resource allocation and expenditure control, and the possible absence benefit of
intubation and intensive care, an endotracheal airway management of poisoned coma patients
might be detrimental.
Thus, if our hypothesis is demonstrated, the results of NICO study will change practice and
guidelines for management of acute coma poisoned patients, with less exposure to the
morbidity of endotracheal intubation and associated with decrease of ICU stay, and reduction
of their health costs.