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

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

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Louis Mourier hospital (AP-HP), Colombes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

The admission variables and those constituting the predictive score (blood pressure, temperature, oxygenotherapy, biological analysis...) will be collected for 48 hours after enrolment (i.e within the first 24 hours of admission )

Primary outcomes

the number of intubations in COVID-19 patients initially hospitalised in wards

Time frame: up to 1 month

Primary outcome measure for the creation of the predictive score

Secondary outcomes

the number of intubations in COVID-19 patients initially hospitalised in wards.

Time frame: up to 1 month

Secondary endpoints for validation of the predictive score

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: May 6, 2020
Registry last updated: Sep 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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