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

NCT04376879 | Completed

• 1 other identifier: 2020-A01076-33
• Study Type: observational
• Target: 301
• Locations: 1 country
• Sites: 2

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  up to 1 month

Study Arms (2)

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

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

Interventions

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 )

Step 1: creation of the score; Step 2: validation of the score

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (2)

Louis Mourier hospital (AP-HP)

Colombes, 92700, France

Location

Brabois Hospital (CHRU de Nancy)

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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 CHAIR

• Patrick ROSSIGNOL, MD-PhD

  CHRU de NANCY

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 6, 2020
• Study Start: May 16, 2020
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: September 10, 2021

Record last verified: 2021-08

Locations

FR (2)