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OpenTrials
Completed

NCT Number: NCT04694638

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Rate of intubation

    Time frame: 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 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 5, 2021
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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