Status:
COMPLETED
Use of Combined Prone Positioning and High-Flow Nasal Cannula, and Non-invasive Positive Pressure Ventilation to Prevent Intubation in COVID-19 Infection
Lead Sponsor:
Mayo Clinic
Conditions:
Prone Positioning
Covid19
Eligibility:
All Genders
18-110 years
Phase:
NA
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 h...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04694638
Start Date
May 21 2020
End Date
May 10 2023
Last Update
October 5 2023
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905