ARDS, Covid19, High Flow Nasal Cannulla, Hypoxemic Respiratory Failure, Non Invasive Ventilation, Prone Positioning
Conditions
Brief summary
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.
Interventions
OTHERBody position change
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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed