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

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

Status
Suspended
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04026217
Enrollment
30
Registered
2019-07-19
Start date
2019-05-27
Completion date
2024-01-31
Last updated
2024-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaphragm Injury, Mechanical Ventilation Complication, Respiratory Failure, Ultrasound

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.

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.

Interventions

None listed

Sponsors

Azienda Sanitaria-Universitaria Integrata di Udine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Diaphragm thickening fractionAt ICU admissionDiaphragm thickening fraction measured with echography

Secondary

MeasureTime frameDescription
Arterial blood gas analysisFrom date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 monthsArterial blood gas analysis
Failure of non-invasive ventilationFrom date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 monthsFailure of non-invasive ventilation according to hospital NIV protocol
Rate of tracheal intubationFrom date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 monthsTracheal intubation
Diaphragm thickening fractionFrom date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 monthsDiaphragm thickening fraction measured with echography
Hospital length of stayFrom date of in-hospital admission until the date of hospital discharge, assessed up to 36 monthsHospital length of stay
In-hospital mortalityFrom date of in-hospital admission until the date of death from any cause or hospital discharge, assessed up to 36 monthsIn-hospital mortality
Duration of positive-pressure ventilationFrom date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 monthsDuration of positive-pressure ventilation (NIV or mechanical ventilation)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026