Tracheal Positive Pressure During High Flow Nasal Oxygen Administration in Critically Ill Patients: a Physiologic Study.

Overview

High flow nasal cannula administration in critically ill patients is frequently used to improve acute respiratory failure or to prevent respiratory failure after extubation. It acts generating a mild positive pressure in the airways and by reducing respiratory effort of patients. However to the best of our knowledge, no study to date has directly measured the amount of positive pressure generated in the trachea of patients. The primary aim, therefore, of this study measures this positive pressure after extubation in critically ill patients.

Full Title of Study: “Invasive Measurement of Positive Tracheal Pressure Generated by High Flow Nasal Oxygen Administration in Critically Ill Patients After Extubation: a Physiologic Study.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 2023

Interventions

  • Device: HIGH FLOW NASAL OXYGEN
    • BEFORE EXTUBATION, AN AIRWAY EXCHANGE CATHETER (AEC) WILL BE PUT INTO THE PATIENTS’ TRACHEA AND IT WILL REMAIN IN SITE AFTER EXTUBATION. THROUGH AN AEC CONNECTED TO A PRESSURE MONITOR, IT WILL BE RECORDED TRACHEAL PRESSURE DURING SPONTANEOUSLY BREATHING PATIENT AT DIFFERENT FLOW RATES OF HFNC THAT WILL BE APPLIED JUST AFTER EXTUBATION. MEANWHILE, VITAL PARAMETERS RECORDED WITH A MULTIPARAMETRIC MONITOR WILL BE RECORDED. FINALLY, MONITORING OF ELECTRICAL ACTIVITY OF DIAPHRAGM WILL BE RECORDED THROUGH A DEDICATED NASOGASTRIC TUBE TO EVALUATE IT AT DIFFERENT FLOW RATES.

Arms, Groups and Cohorts

  • CRITICALLY ILL PATIENTS
    • CRITICALLY ILL PATIENTS AFTER INVASIVE MECHANICAL VENTILATION READY TO BE EXTUBATED.

Clinical Trial Outcome Measures

Primary Measures

  • HFNC-PEEP
    • Time Frame: 3 HOURS
    • THE LEVEL OF POSITIVE AIRWAY PRESSURE GENERATED BY DIFFERENT FLOW RATES OX OXYGEN WILL BE RECORDED. FLOW RATE STARTS AT 10 L/MIN AND IT WILL BE INCREASED A 10 L/MIN STEP EVERY 30 MINUTES UNTIL 60 L/MIN.

Secondary Measures

  • HFNC-EADI
    • Time Frame: 3 HOURS
    • ELECTRICAL ACTIVITY OF THE DIAPHRAGM WILL BE RECORDED THROUGH A DEDICATED NASOGASTRIC TUBE DURING ALL THE PROCESS. FLOW RATE STARTS AT 10 L/MIN AND IT WILL BE INCREASED A 10 L/MIN STEP EVERY 30 MINUTES UNTIL 60 L/MIN.

Participating in This Clinical Trial

Inclusion Criteria

CRITICALLY ILL PATIENTS AFTER MECHANICAL VENTILATION LASTED AT LEAST 72 HOURS

  • age 18-80 years Exclusion Criteria:

  • COPD stage >1 according to GOLD classification – end stage organ disease (liver, kidney, heart, lung) – neuromuscular disease – neoplasm – previous tracheostomy – obesity with BMI > 35 Kg/m2 – non collaborative patient

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Azienda Sanitaria-Universitaria Integrata di Udine
  • Provider of Information About this Clinical Study
    • Principal Investigator: Cristian Deana, Medical Doctor, Anesthesiologist and Critical Care Physician – Azienda Sanitaria-Universitaria Integrata di Udine
  • Overall Official(s)
    • Cristian Deana, MD, Principal Investigator, Health Integrated Agency of Friuli Centrale, via Pozzuolo 330, 33100 Udine, Italy
  • Overall Contact(s)
    • Cristian Deana, MD, +390432552410, cristian.deana@asufc.sanita.fvg.it

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