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

Sponsor
Azienda Sanitaria-Universitaria Integrata di Udine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05467332
Collaborator
(none)
20
1
12
1.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: HIGH FLOW NASAL OXYGEN

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Invasive Measurement of Positive Tracheal Pressure Generated by High Flow Nasal Oxygen Administration in Critically Ill Patients After Extubation: a Physiologic Study.
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
CRITICALLY ILL PATIENTS

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

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.
Other Names:
  • AIRVO2, FISHER&PAYKEL
  • Outcome Measures

    Primary Outcome Measures

    1. HFNC-PEEP [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 Outcome Measures

    1. HFNC-EADI [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cristian Deana Udine Italy 33100

    Sponsors and Collaborators

    • Azienda Sanitaria-Universitaria Integrata di Udine

    Investigators

    • Principal Investigator: Cristian Deana, MD, Health Integrated Agency of Friuli Centrale, via Pozzuolo 330, 33100 Udine, Italy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cristian Deana, Medical Doctor, Anesthesiologist and Critical Care Physician, Azienda Sanitaria-Universitaria Integrata di Udine
    ClinicalTrials.gov Identifier:
    NCT05467332
    Other Study ID Numbers:
    • HPEEP
    First Posted:
    Jul 20, 2022
    Last Update Posted:
    Jul 26, 2022
    Last Verified:
    Jul 1, 2022
    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
    Keywords provided by Cristian Deana, Medical Doctor, Anesthesiologist and Critical Care Physician, Azienda Sanitaria-Universitaria Integrata di Udine
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 26, 2022