Use of Combined Prone Positioning and High-Flow Nasal Cannula, and Non-invasive Positive Pressure Ventilation to Prevent Intubation in COVID-19 Infection

Recruitment & Eligibility

Inclusion Criteria

Patients with confirmed COVID19 infection or suspected COVID19 infection.
Patients requiring HFNC or NIPPV
Patients who are clinically stable and able to tolerate the changes in position that are routinely conducted as part of the standard of care in the medical ICU.
Patient should be able to provide informed consent to the study. Any participant speaking any language will be offered participation.
Able to actively participate in Assisted Manual Pronation Therapy per nursing assessment.

Exclusion Criteria

Contraindication for prone positioning:

Intracranial pressure >30 mm Hg or cerebral perfusion pressure <60 mmHg
Massive hemoptysis requiring an immediate surgical or interventional radiology procedure
Tracheal surgery or sternotomy during the previous 15 days
Serious facial trauma or facial surgery during the previous 15 days
Deep venous thrombosis treated for less than 2 days
Cardiac pacemaker inserted in the last 2 days
Unstable spine, femur, or pelvic fractures
Hemodynamic instability or severe cardiac arrhythmia (chronic AFib is not a contraindication). Mean arterial pressure lower than 60 mm Hg, >1 vasopressor agent or Norepinephrine equivalent dose >0.06 mcg/kg/min
Pregnant women
Single anterior chest tube with air leaks
Burns on more than 20 % of the body surface
Delirium or altered mental status increasing fall risk while in prone position.
End-of-life decision before inclusion
Subject deprived of freedom, minor, subject under a legal protective measure
Unable to actively participate in Assisted Manual Pronation Therapy per nursing assessment
Lacking capacity to provide informed consent.
Individuals with mechanical or vascular disease precluding safe displacement of the head, for example: cervical spinal fusion, limited range of motion, or severe vascular occlusive disease of the head and neck.
Body mass index (BMI) greater than 70 kg/m2, or unable to actively participate in Assisted Manual Pronation Therapy per nursing assessment at any BMI value.

Study & Design

Arm && Interventions

Group	Intervention	Description
HFNC and NIPPV	Body position change	Combined use of prone positioning and non-invasive positive pressure ventilation (NIPPV) and high-flow nasal cannula (HFNC)

Primary Outcome Measures

Name	Time	Method
Rate of intubation	1 year	Number of critically ill patients with acute hypoxemic and/or hypercapnic respiratory failure, secondary to COVID-19 infection to require intubation and mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
Incidence of hypotension and cardiac arrhythmias and other nursing-related risks of combining prone positioning with high-flow nasal cannula and non-invasive positive pressure ventilation	1 year	To evaluate the the incidence of hypotension and cardiac arrhythmias and other nursing-related risks of combining prone positioning with high-flow nasal cannula and non-invasive positive pressure ventilation.

Recruitment & Eligibility