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

NCT ID: NCT04694638

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-21
• Study Completion Date: 2023-05-10

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

HFNC and NIPPV

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

Group Type: EXPERIMENTAL

Body position change

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Gustavo A. Cortes Puentes

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gustavo Cortes Puentes, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

20-003191

Identifier Type: -

Identifier Source: org_study_id