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

Study Overview
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Brief Summary
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This research aims to understand if prone positioning combined with high-flow nasal cannula (HFNC) or non-invasive positive pressure ventilation (NIPPV) safely reduce the rate of intubation in acute hypoxemic and/or hypercapnic respiratory failure secondary to COVID-19 infection.

Official Title
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The Use of Combined Prone Positioning and High-Flow Nasal Cannula, and Non-invasive Positive Pressure Ventilation to Prevent Intubation in Acute Hypoxemic and/or Hypercapnic Respiratory Failure Secondary to COVID-19 Infection: A Feasibility, Safety Phase One, Open Label Study

Conditions
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Prone Positioning, Covid19, Hypoxemic Respiratory Failure, ARDS, Non Invasive Ventilation, High Flow Nasal Cannulla

Intervention / Treatment
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* Other: Body position change


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFNC and NIPPV<br>Combined use of prone positioning and non-invasive positive pressure ventilation (NIPPV) and high-flow nasal cannula (HFNC) | Other: Body position change<br>* combined use of prone positioning and high-flow nasal cannula (HFNC) and non-invasive positive pressure ventilation (NIPPV) can reduce the rate of intubation in acute hypoxemic and/or hypercapnic respiratory failure secondary to COVID-19 infection.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 1 year |