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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04376879
Enrollment
301
Registered
2020-05-06
Start date
2020-05-16
Completion date
2021-05-31
Last updated
2021-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

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

Interventions

OTHERData 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 )

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
the number of intubations in COVID-19 patients initially hospitalised in wardsup to 1 monthPrimary outcome measure for the creation of the predictive score

Secondary

MeasureTime frameDescription
the number of intubations in COVID-19 patients initially hospitalised in wards.up to 1 monthSecondary endpoints for validation of the predictive score

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026