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

January 29, 2024 updated by: Luigi Vetrugno, Azienda Sanitaria-Universitaria Integrata di Udine

Evaluation of Diaphragmatic Function in Hematological Patients With Acute Hypoxemic Respiratory Failure

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.

Study Overview

Status

Suspended

Conditions

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 Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Udine, Italy, 33100
        • Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Hematologic patients with hypoxemic respiratory failure

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diaphragm thickening fraction
Time Frame: At ICU admission
Diaphragm thickening fraction measured with echography
At ICU admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diaphragm thickening fraction
Time Frame: 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
From date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 months
Arterial blood gas analysis
Time Frame: From date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 months
Arterial blood gas analysis
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
Time Frame: 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
From date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 months
Rate of tracheal intubation
Time Frame: From date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 months
Tracheal intubation
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
Time Frame: 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)
From date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 months
Hospital length of stay
Time Frame: From date of in-hospital admission until the date of hospital discharge, assessed up to 36 months
Hospital length of stay
From date of in-hospital admission until the date of hospital discharge, assessed up to 36 months
In-hospital mortality
Time Frame: 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
From date of in-hospital admission until the date of death from any cause or hospital discharge, assessed up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Sanitaria-Universitaria Integrata di Udine

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2019

Primary Completion (Actual)

December 27, 2021

Study Completion (Estimated)

January 31, 2024

Study Registration Dates

First Submitted

June 15, 2019

First Submitted That Met QC Criteria

July 17, 2019

First Posted (Actual)

July 19, 2019

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2745

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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