Clinical trial NCT04694638: Use of Combined Prone Positioning and High-Flow Nasal Cannula, and Non-invasive Positive Pressure Ventilation to Prevent Intubation in COVID-19 Infection
Official title: The Use of Combined Prone Positioning and High-Flow Nasal Cannula, and Non-invasive Positive Pressure Ventilation to Prevent Intubation in Acute Hypoxemic and/or Hypercapnic Respiratory Failure Secondary to COVID-19 Infection: A Feasibility, Safety Phase One, Open Label Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prone Positioning
Covid19
Hypoxemic Respiratory Failure
ARDS
Non Invasive Ventilation
High Flow Nasal Cannulla
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility study
Primary purpose: SUPPORTIVE_CARE

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 hypoxemic and/or hypercapnic respiratory failure secondary to COVID-19 infection.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of intubation
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of hypotension and cardiac arrhythmias and other nursing-related risks of combining prone positioning with high-flow nasal cannula and non-invasive positive pressure ventilation
timeFrame: 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Gustavo Cortes Puentes, MD
role: PRINCIPAL_INVESTIGATOR
References: