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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

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04694638
Collaborator
(none)
24
Enrollment
1
Location
1
Arm
25.3
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Body position change
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Feasibility studyFeasibility study
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
May 21, 2020
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: HFNC and NIPPV

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

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  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]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 110 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Gustavo Cortes Puentes, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Gustavo A. Cortes Puentes, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT04694638
Other Study ID Numbers:
  • 20-003191
First Posted:
Jan 5, 2021
Last Update Posted:
Aug 13, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19
Respiratory Insufficiency

Study Results

No Results Posted as of Aug 13, 2021