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

Not Applicable

Completed

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

• Registration Number: NCT04694638
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-21
• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2021-01-03
• Study First Posted: 2021-01-05
• Primary Completion: 2023-05-10
• Study Completion: 2023-05-10
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States