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
Arm | Description | Assigned Intervention |
---|---|---|
Experimental HFNC and NIPPV |
Combined use of prone positioning and non-invasive positive pressure ventilation (NIPPV) and high-flow nasal cannula (HFNC) |
|
Recruiting Locations
More Details
- NCT ID
- NCT04694638
- Status
- Completed
- Sponsor
- Mayo Clinic