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

Mayo Clinic

Status

Completed

Conditions

Non Invasive Ventilation

High Flow Nasal Cannulla

Hypoxemic Respiratory Failure

Covid19

ARDS

Prone Positioning

Treatments

Other: Body position change

Study type

Interventional

Funder types

Other

Identifiers

NCT04694638

20-003191

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18 to 110 years old

Volunteers

No Healthy Volunteers

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.