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

NCT04026217 | Suspended

• 1 other identifier: 2745
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure; Diaphragm Injury; Ultrasound; Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (1)

• Diaphragm thickening fraction

  Diaphragm thickening fraction measured with echography

  At ICU admission

Secondary Outcomes (7)

• Diaphragm thickening fraction

  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

  From date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 months

• Rate of 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

  From date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hematologic patients with hypoxemic respiratory failure

You may qualify if:

• Hypoxemic respiratory failure in hematological patients (PaO2 \< 70 mmHg or P/F \< 150)

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Sanitaria-Universitaria Integrata di Udine: lead

Study Sites (1)

Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD

Udine, 33100, Italy

Location

Related Publications (32)

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MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Luigi Vetrugno, Doctor

  Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Luigi Vetrugno, M.D., Anesthesiology and Intensive Care Clinic, Department of Medicine, University of Udine

Study Record Dates

• First Submitted: June 15, 2019
• First Posted: July 19, 2019
• Study Start: May 27, 2019
• Primary Completion: December 27, 2021
• Study Completion: January 31, 2024
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

IT (1)