Clinical trial NCT04376879: Predicting the Need for Intubation in Hospitalised COVID-19 Patients (PRED ICU COVID19)
Official title: Predicting the Need for Intubation in Hospitalised COVID-19 Patients (PRED ICU COVID19)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Proven or expected COVID-19 patients hospitalised in a non-intensive care unit for less than 24 hours

Brief summary: One of the main challenges of the health crisis caused by the COVID-19 epidemic is the availability of beds in intensive care units (ICUs) and, more importantly, the need for invasive mechanical ventilation (IVM) because the ICUs are currently reserved for intubated patients.

The experiences of both China and Italy indicate that a certain number of COVID-19 patients will require mechanical ventilation. However, the limited number of resuscitation beds and ventilators requires strict use of these scarce resources. As a significant proportion about 5% to 10%, of patients initially admitted to hospital with COVID-19 will require ventilation, it is essential to anticipate their need for resuscitation to improve the rare resource of beds and ventilator shortages in intensive care units.

The hypothesis of the study is that, in proven or suspected hospitalised and oxygen-requiring COVID-19 patients, an early predictive clinical score, calculated over the three first days of admission may allow for an earlier identification of patients who will require intubation and transfer to an intensive care unit for orotracheal intubation


Eligibility criteria: Inclusion Criteria:

* Proven or expected COVID-19 patients hospitalised in a non-intensive care unit for less than 24 hours,
* Patients requiring oxygen therapy,
* Age ≥ 18 years old.

Exclusion Criteria:

* Patients who are opposed to taking part in the study and who are opposed to the collection and use of the data that the study aims to collect.,
* Patients who can not be intubated for medical reasons,
* Pregnant women, parturient women or nursing mothers ,
* Adult person subject to a legal protection measure (guardianship, curatorship, judicial safeguard),
* Adults person who is unable to give consent and who is not subject to a legal protection measure,
* Persons deprived of their liberty by a judicial or administrative decision,
* Persons subject to psychiatric care under duress.

Primary outcomes:
measure: the number of intubations in COVID-19 patients initially hospitalised in wards
timeFrame: up to 1 month
Secondary outcomes:
measure: the number of intubations in COVID-19 patients initially hospitalised in wards.
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Colombes
country: France
facility: Louis Mourier hospital (AP-HP)
city: Vandœuvre-lès-Nancy
country: France
facility: Brabois Hospital (CHRU de Nancy)
Study officials:
affiliation: CHRU de NANCY
name: Antoine KIMMOUN, MD-PhD
role: STUDY_CHAIR
affiliation: AP-HP, Louis Mourier Hospital
name: Jean Damien RICARD, MD-PhD
role: STUDY_CHAIR
affiliation: Institut National de Recherche en Informatique et en Automatique
name: Julie JOSSE, PhD
role: STUDY_CHAIR
affiliation: CHRU de NANCY
name: Patrick ROSSIGNOL, MD-PhD
role: STUDY_CHAIR
References: