NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

CORONA (COvid pRONe hypoxemiA): Prone Positioning for Hypoxemic COVID-19 Patients With Do-not-intubate Goals

CompletedNA

Sponsor: University of Calgary

Conditions: Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19, Acute Respiratory Distress Syndrome, ARDS, Hypoxemic Respiratory Failure

Interventions: Prone Positioning (PP)

Countries: Canada

The purpose of this trial is to determine whether Prone Positioning (PP) improves outcomes for non-intubated hospitalized patients with hypoxemic respiratory failure due to COVID-19, who are not candidates for mechanical ventilation in the ICU. The investigators hypothesize that PP will reduce in-hospital mortality or discharge to hospice, compared with usual care for non-intubated patients with do-not-intubate goals of care with hypoxemic respiratory failure due to probable COVID-19.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Hospitalized patients with probable COVID-19. Probable is defined as Influenza like illness (ILI) symptoms OR confirmed COVID-19 exposure AND COVID-19 testing performed. ILI is defined as any one of the following symptoms including: fever, new or worsening cough, coryza, new or worsening dyspnea, or sore throat.
* Goals of care are do-not-intubate (R3 or M1/M2 in Alberta).
* Need for oxygen ≥2 L to maintain SpO2 ≥92%. If the patient is on long-term oxygen, the O2 requirements must be ≥2 L above their baseline.
* Patient can be positioned to and from prone to supine with minimal assistance (maximum one person assistance).

Exclusion Criteria:

* Decreased level of consciousness (Glasgow Coma Scale \< 10) or precluding ability to self-reposition.
* Hemodynamic instability (Systolic Blood Pressure \< 90 mmHg and or Lactate \>5 mmol/L or HR \>120, not responsive to fluid resuscitation).
* Complete bowel obstruction.
* Active upper gastrointestinal bleeding.
* Poor neck mobility or patient inability to lie prone comfortably.
* Unstable spine, femur, or pelvic fractures.
* Pregnancy - third trimester.
* Full resuscitation status including ICU and willingness to accept invasive mechanical ventilation (i.e. R1/R2 goals of care).
* Imminent palliation or end of life expected on admission (i.e. C1/C2 goals of care).

Locations (4)

Calgary, Alberta, Canada
Calgary, Alberta, Canada
Calgary, Alberta, Canada
Calgary, Alberta, Canada