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

Purpose

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.

Conditions

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

Eligibility

Eligible Ages
Between 18 Years and 110 Years
Eligible Genders
All
Accepts 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Feasibility study
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
HFNC and NIPPV
Combined use of prone positioning and non-invasive positive pressure ventilation (NIPPV) and high-flow nasal cannula (HFNC)
  • Other: Body 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.

Recruiting Locations

More Details

NCT ID
NCT04694638
Status
Completed
Sponsor
Mayo Clinic