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Diaphragm Ultrasound as a Powerful Tool in Managing Acute Hypoxemic Respiratory Failure in Hematological Patients

Sponsor
Azienda Sanitaria-Universitaria Integrata di Udine (Other)
Overall Status
Recruiting
CT.gov ID
NCT04026217
Collaborator
(none)
30
Enrollment
1
Location
36
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Acute hypoxemic respiratory failure due to parenchymal disfunction is one of the main complications of immunocompromised hematological patients. Mechanical ventilation is frequently needed and diaphragm activity has to be assessed not to worsen ventilator-induced lung injury.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Acute hypoxemic respiratory failure due to parenchymal disfunction is one of the main complications of immunocompromised hematological patients. In these cohort of patients mechanical ventilation is frequently needed in order to restore oxygenation and normocapnia. Since every positive-pressure ventilation regimen may potentially determine pulmonary complications, due to alteration in pressure and volume lung homeostasis and diaphragm activity, also diaphragm function has to be assessed not to worsen ventilator-induced lung injury (VILI). Main targets of VILI are pulmonary interstitium and diaphragm.

    Pulmonary interstitium is frequently involved in different mechanism of injury, that derive both from induced tidal volume and positive end expiratory pressure (PEEP). Indeed, large tidal volumes generated during assisted spontaneous breathing may configure non-protective ventilation regimens and the so called "pendelluft phenomenon", that is the intrinsic flow of air within the lung from nondependent to dependent regions without changes in tidal volume, may affect inadequate PEEP values.

    Positive-pressure ventilation may also alter diaphragm activity. Recent data show that diaphragm disfunction, considered as an enhanced or reduced thickening fraction, occurs in about 65% of patients undergoing mechanical ventilation.

    Since the potential harm of positive-pressure ventilation, the optimization of mechanical ventilation is pivotal to ensure an adequate time-to-recovery without concurring to the onset of further lung and diaphragmatic injury. Neurally Adjusted Ventilatory Assist (NAVA) is a recent modality of mechanical ventilation that delivers ventilatory assistance according to the respiratory effort of the patient, measured by electrical activity of the diaphragm (EAdi). NAVA works proportionally with EAdi values, ensuring a better neuroventilatory efficiency compared to other mechanical ventilation modes and also reducing patient-ventilator asynchrony. According to these features NAVA protocol may be useful in preserving gas exchanges and diaphragm function both in invasive and non-invasive ventilation.

    Therefore the evaluation of basal diaphragm activity, the choice of the device for oxygen support administration and the setting of ventilatory parameters may influence hospital stay and outcome of patients affected by acute hypoxemic respiratory failure.

    The aim of this study is to evaluate the basal diaphragm activity of acute hypoxemic respiratory failure patients admitted in Intensive Care Unit (ICU) and to record diaphragm activity modifications during the ICU stay in relation to the optimization of medical therapy and, if necessary, according to the need of ventilatory support (invasive or non-invasive ventilation delivered with NAVA protocol).

    This study intends to register also daily diaphragm thickening fraction, daily arterial blood gas analysis, failure frequency of non-invasive ventilation, frequency of tracheal intubation, length of mechanical ventilation, length of hospital stay and hospital mortality.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Diaphragmatic Function in Hematological Patients With Acute Hypoxemic Respiratory Failure
    Actual Study Start Date :
    May 27, 2019
    Anticipated Primary Completion Date :
    May 27, 2022
    Anticipated Study Completion Date :
    May 27, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Diaphragm thickening fraction [At ICU admission]

      Diaphragm thickening fraction measured with echography

    Secondary Outcome Measures

    1. Diaphragm thickening fraction [From date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 months]

      Diaphragm thickening fraction measured with echography

    2. Arterial blood gas analysis [From date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 months]

      Arterial blood gas analysis

    3. Failure of non-invasive ventilation [From date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 months]

      Failure of non-invasive ventilation according to hospital NIV protocol

    4. Rate of tracheal intubation [From date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 months]

      Tracheal intubation

    5. Duration of positive-pressure ventilation [From date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 months]

      Duration of positive-pressure ventilation (NIV or mechanical ventilation)

    6. Hospital length of stay [From date of in-hospital admission until the date of hospital discharge, assessed up to 36 months]

      Hospital length of stay

    7. In-hospital mortality [From date of in-hospital admission until the date of death from any cause or hospital discharge, assessed up to 36 months]

      In-hospital mortality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Hypoxemic respiratory failure in hematological patients (PaO2 < 70 mmHg or P/F < 150)
    Exclusion Criteria:

    • Patients with positive-pressure ventilation regimen of high flow nasal cannula prior to ICU admission

    • Unstable clinical condition (use of vasopressors, acute coronary syndrome...)

    • Refusal of treatment or informed consent

    • Agitation (RASS ≥+2) or lack of collaboration (Kelly Matthay ≥ 5)

    • Multiple organ failure

    • Enrollment in other study protocols

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD Udine Italy 33100

    Sponsors and Collaborators

    • Azienda Sanitaria-Universitaria Integrata di Udine

    Investigators

    • Principal Investigator: Luigi Vetrugno, Doctor, Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Luigi Vetrugno, Luigi Vetrugno, M.D., Anesthesiology and Intensive Care Clinic, Department of Medicine, University of Udine, Azienda Sanitaria-Universitaria Integrata di Udine
    ClinicalTrials.gov Identifier:
    NCT04026217
    Other Study ID Numbers:
    • 2745
    First Posted:
    Jul 19, 2019
    Last Update Posted:
    Oct 8, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Respiratory Insufficiency

    Study Results

    No Results Posted as of Oct 8, 2020