Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05821491 |
| Other study ID # |
APHP221326 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 12, 2022 |
| Est. completion date |
January 13, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Retrospective, multicenter, French cohort study. Data from patients over 75 years of age who
visited the emergency department on 12 and 13 December 2022 could be collected until their
discharge from hospital and for a maximum of 30 days. Data from patients who spent the night
on a stretcher (stretcher group) as well as from a group of patients who spent the night in a
bed (hospital bed group) after a visit to the emergency department will be collected.
The characteristics of the patients and their stay in the emergency room will be collected,
and their hospital stay (truncated at 30 days) will be analyzed in terms of morbidity and
mortality.
Main objective:
To study the truncated 30-day in-hospital mortality of patients who spent a night on a
stretcher in the emergency department.
Secondary objectives:
To describe the characteristics and hospital stay of patients who spent a night on a
stretcher To compare the morbidity and mortality of patients who spent the night on a
stretcher with patients who spent the night in an inpatient bed after an emergency visit;
Description:
The activity and number of admissions to emergency departments are constantly increasing,
resulting in the overloading of emergency departments, a problem shared by most Western
countries, for a variety of reasons. The ageing of the population and the increasing scarcity
of outpatient medical services have led to an increase in the number of consultations in
emergency departments by patients aged over 75. These demographic changes and the reduction
in the number of hospital beds in France have led to overcrowding in emergency departments
(EDs), with long waiting times for patients to be admitted to hospital. Emergency department
overcrowding is directly associated with an increase in mortality at 24 hours (adjusted OR
1.42; 95%CI 1.08-1.88) and at 72 hours (adjusted OR 1.27; 95%CI 1.02-1.58) after a visit to
the emergency department. Similarly, several retrospective studies report an association
between in-hospital mortality and the time spent in the emergency department, and the time
spent waiting for a hospital bed in particular.
The No Bed Challenge, organised by Samu Urgences de France (SUDF) in 2018, identified
patients who spent the night on a stretcher waiting for a hospital bed. Beyond the long
waiting time and its association with excess mortality, spending the night on a stretcher can
be associated with a worsening prognosis: the conditions of care and comfort are degraded,
and the risks inherent in such a nightly wait on a stretcher are multiple. It has been
described that beyond 5 hours, waiting is linked with a linear increase in 30-day mortality.
In addition, several retrospective studies report a longer waiting time for a downstream
hospitalization bed for the geriatric patient population. This longer waiting time is also
associated with the occurrence of adverse events, increasing by 3% for each hour spent in the
emergency department. However, the characteristics of patients spending the night in the
emergency department while waiting for a hospital bed, and their prognosis, are not known -
particularly in France.
The objective of the NoBedNight study is to study the in-hospital mortality of patients over
75 years old who spent the night on a stretcher. It will also allow us to describe the
typology of these patients, and to compare them to a similar population who had access to an
outpatient bed after a visit to the emergency room.
The study aim to evaluate the in-hospital mortality of patients over 75 years old spending
the night on a stretcher in the emergency room while waiting for an inpatient bed by
collecting data collected in the course of care.
This national retrospective multicentre cohort study will provide information on the clinical
characteristics of this population, their frailty index (assessed by Charlson's Comorbidity
Index) and their level of dependence (GIR scale) which will be calculated a posteriori on the
data collected during care, as well as their clinical presentation, their reason for referral
and the occurrence of complications during hospitalisation.
It will make it possible to evaluate the number of geriatric patients waiting for a hospital
bed over a short-predefined period in our French emergency services.
The increase in the overload of emergency departments leads to regular national crises in
France and in Western countries. It is important to assess the consequences on the health of
patients, particularly geriatric patients.
According to the literature, the hypothesis is that mortality is increased in geriatric
patients who spend a night on a stretcher in an emergency department because they do not have
an inpatient bed.
In recent years, many ideas have been put forward to alleviate the overloading of emergency
departments, the cause of which is multifactorial. However, obtaining precise and updated
data will make it possible to evaluate the magnitude of the risks inherent in waiting for an
outpatient hospital bed for elderly patients and to conclude on the mortality of patients at
30 days.
