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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04694638
• Other study ID #: 20-003191
• Status: Completed
• Phase: N/A
• Start date: May 21, 2020
• Est. completion date: May 10, 2023

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 10, 2023
• Est. primary completion date: May 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• ARDS
• COVID-19
• Covid19
• High Flow Nasal Cannulla
• Hypoxemic Respiratory Failure
• Non Invasive Ventilation
• Prone Positioning
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Mayo Clinic Clinical Trials