Predicting the Need for Intubation in Hospitalised COVID-19 Patients (PRED ICU COVID19)

Central Hospital, Nancy, France

Status: Completed

Conditions: COVID-19

Treatments: Other: Data monitoring for 48h within the first 24 hours of admission for COVID-19

Study type: Observational

Funder types: Other

Identifiers

NCT04376879

2020-A01076-33

Details and patient eligibility

About

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

Enrollment: 301 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

301 participants in 2 patient groups

Step 1: creation of the score

Description:

Cohort for the creation of clinical-biological score to predict the risk of intubation in COVID-19

Treatment:

Other: Data monitoring for 48h within the first 24 hours of admission for COVID-19

Step 2: validation of the score

Description:

Cohort for the validation of clinical-biological score to predict the risk of intubation in COVID-19

Treatment:

Other: Data monitoring for 48h within the first 24 hours of admission for COVID-19