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

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Other: Data monitoring for 48h within the first 24 hours of admission for COVID-19

• Study Type: Observational
• Enrollment (Actual): 301

Contacts and Locations

Study Locations

• France
  • Colombes, France, 92700
    • Louis Mourier hospital (AP-HP)
  • Vandœuvre-lès-Nancy, France, 54500
    • Brabois Hospital (CHRU de Nancy)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Step 1: creation of the score; Cohort for the creation of clinical-biological score to predict the risk of intubation in COVID-19	Other: Data monitoring for 48h within the first 24 hours of admission for COVID-19; 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 )
Step 2: validation of the score; Cohort for the validation of clinical-biological score to predict the risk of intubation in COVID-19	Other: Data monitoring for 48h within the first 24 hours of admission for COVID-19; 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 )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the number of intubations in COVID-19 patients initially hospitalised in wards	Primary outcome measure for the creation of the predictive score	up to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the number of intubations in COVID-19 patients initially hospitalised in wards.	Secondary endpoints for validation of the predictive score	up to 1 month

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Study Chair: Antoine KIMMOUN, MD-PhD, CHRU de Nancy; Study Chair: Jean Damien RICARD, MD-PhD, AP-HP, Louis Mourier Hospital; Study Chair: Julie JOSSE, PhD, Institut National de Recherche en Informatique et en Automatique

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2020
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): September 10, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020-A01076-33

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No