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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Key Inclusion Criteria:

  1. Patients with confirmed COVID19 infection or suspected COVID19 infection
  2. Patients requiring high-flow nasal cannula (HFNC) or non-invasive positive pressure ventilation (NIPPV)
  3. 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
  4. Patient/responsible family member signing the informed consent must speak English
  5. Able to actively participate in Assisted Manual Pronation Therapy per nursing assessment
     
    Exclusion Criteria: 
     
    Contraindication for prone positioning:
  1. Intracranial pressure >30 mm Hg or cerebral perfusion pressure <60 mmHg
  2. Massive hemoptysis requiring an immediate surgical or interventional radiology procedure
  3. Tracheal surgery or sternotomy during the previous 15 days
  4. Serious facial trauma or facial surgery during the previous 15 days
  5. Deep venous thrombosis treated for less than 2 days
  6. Cardiac pacemaker inserted in the last 2 days
  7. Unstable spine, femur, or pelvic fractures
  8. 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
  9. Pregnant women
  10. Single anterior chest tube with air leaks
  11. Burns on more than 20 % of the body surface
  12. Delirium or altered mental status increasing fall risk while in prone position.
  13. End-of-life decision before inclusion
  14. Subject deprived of freedom, minor, subject under a legal protective measure
  15. Opposition from next of kin
  16. Unable to actively participate in Assisted Manual Pronation Therapy per nursing assessment

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Gustavo Cortes Puentes, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Gustavo Cortes Puentes M.D.

CortesPuentes.Gustavo@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20487855

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