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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04376879
• Other study ID #: 2020-A01076-33
• Status: Completed
• Start date: May 16, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: August 2021
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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 )

Locations

Country	Name	City	State
France	Louis Mourier hospital (AP-HP)	Colombes
France	Brabois Hospital (CHRU de Nancy)	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the number of intubations in COVID-19 patients initially hospitalised in wards.	Secondary endpoints for validation of the predictive score	up to 1 month