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

Completed

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

• Registration Number: NCT04376879
• Lead Sponsor: Central Hospital, Nancy, France

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-05
• Study First Posted: 2020-05-06
• Study Start: 2020-05-16
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Brabois Hospital (CHRU de Nancy); 🇫🇷 Vandœuvre-lès-Nancy, France

Louis Mourier hospital (AP-HP); 🇫🇷 Colombes, France