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

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19; ARDS; Hypoxemic Respiratory Failure; Non Invasive Ventilation; Prone Positioning; High Flow Nasal Cannulla
• Intervention / Treatment: Other: Body position change

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HFNC and NIPPV; Combined use of prone positioning and non-invasive positive pressure ventilation (NIPPV) and high-flow nasal cannula (HFNC)	Other: Body position change; combined use of prone positioning and high-flow nasal cannula (HFNC) and non-invasive positive pressure ventilation (NIPPV) can reduce the rate of intubation in acute hypoxemic and/or hypercapnic respiratory failure secondary to COVID-19 infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of intubation	Number of critically ill patients with acute hypoxemic and/or hypercapnic respiratory failure, secondary to COVID-19 infection to require intubation and mechanical ventilation	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	To evaluate the the 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.	1 year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Gustavo Cortes Puentes, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2020
• Primary Completion (Actual): May 10, 2023
• Study Completion (Actual): May 10, 2023

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: January 3, 2021
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiratory Insufficiency
• Other Study ID Numbers: 20-003191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No