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

Primary Purpose

Prone Positioning, Covid19, Hypoxemic Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Body position change
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prone Positioning

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HFNC and NIPPV

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
July 14, 2020
Last Updated
October 3, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04694638
Brief Title
Use of Combined Prone Positioning and High-Flow Nasal Cannula, and Non-invasive Positive Pressure Ventilation to Prevent Intubation in COVID-19 Infection
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 21, 2020 (Actual)
Primary Completion Date
May 10, 2023 (Actual)
Study Completion Date
May 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prone Positioning, Covid19, Hypoxemic Respiratory Failure, ARDS, Non Invasive Ventilation, High Flow Nasal Cannulla

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Feasibility study
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HFNC and NIPPV
Arm Type
Experimental
Arm Description
Combined use of prone positioning and non-invasive positive pressure ventilation (NIPPV) and high-flow nasal cannula (HFNC)
Intervention Type
Other
Intervention Name(s)
Body position change
Intervention Description
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 Outcome Measure Information:
Title
Rate of intubation
Description
Number of critically ill patients with acute hypoxemic and/or hypercapnic respiratory failure, secondary to COVID-19 infection to require intubation and mechanical ventilation
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustavo Cortes Puentes, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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