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

NCT04694638 | Completed

• 1 other identifier: 20-003191
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Prone Positioning; Covid19; Hypoxemic Respiratory Failure; ARDS; Non Invasive Ventilation; High Flow Nasal Cannulla

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

HFNC and NIPPV

EXPERIMENTAL

Combined use of prone positioning and non-invasive positive pressure ventilation (NIPPV) and high-flow nasal cannula (HFNC)

Other: Body position change

Interventions

Body position change OTHER

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.

HFNC and NIPPV

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subject deprived of freedom, minor, subject under a legal protective measure
• Unable to actively participate in Assisted Manual Pronation Therapy per nursing assessment

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

COVID-19; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Gustavo Cortes Puentes, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Feasibility study

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: January 5, 2021
• Study Start: May 21, 2020
• Primary Completion: May 10, 2023
• Study Completion: May 10, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)