Use of Simplified Lung Ultrasound Score for Predicting ICU Outcomes in Patients with Acute Respiratory Failure

NCT06678035 | Not Yet Recruiting

• 1 other identifier: Chest US in ICU
• Study Type: observational
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to Primary Aims: Verify the predictability of the PLIS at admission in predicting major clinical outcomes including:

• ICU mortality (or discharge) and time to death (or discharge)
• Escalation of ventilatory support antibiotic therapy or supportive medications (inotropes, steroids, sedation, neuromuscular blockers). Secondary Aims:
• Determine the correlation between initial PLIS and the degree of disease severity (as evaluated per SOFA and APACHE II scores)
• Determine the correlation between initial PLIS and partial pressure of oxygen in arterial blood (PaO2) to Fraction of inspired oxygen (FiO2): PaO2/FiO2
• Explore the potential association between the type of ventilatory support, ventilatory settings and PLIS at different time points.
• Verify whether the site of consolidation (anterior vs. posterior lung zones) can reliably predict mortality in in ALI patients.
• Determine the correlation between the PLIS score and the degree of ALI as quantified by CT of the chest (whenever a CT study is available) at the time of admission.

Conditions

Pneumnia; Chest Infection; Critically-ill Patients Admitted to the ICU for Acute Respitatory Failure, Regardless the Aetilogy

Keywords

LUS; Acute respiratory failure; Critically-ill patients

Outcome Measures

Primary Outcomes (2)

• ICU Mortality

  Percentage of patients who will die during their ICU admission

  60 days

• Time to death/discharge

  Number of days until the patient dies inside the ICU or becomes discharged from ICU

  60 days

Secondary Outcomes (3)

• Need for Therapy escalation: Ventilatory Support

  60 days

• Need for Therapy Escalation: Ventilatory seetings

  60 days

• Need for Therapy Escalation: Medications

  60 days

Eligibility Criteria

• Age: 18 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are more than 18 years in repiratory failure in ICU and use of chest us in supine or semisupine position

You may qualify if:

• Age is or more than 18 years old.
• Admission to ICU in the first24 hours at time of recruitment to the study.
• Patients in respiratory failure \[PaO2 is less then 60 % mmHg\]

You may not qualify if:

• Co- existing chronic lung disease, pathology of which is known display abnormalities on US examination (interstitial lung diseases, bronchiectasis).
• Large pneumothorax or massive pleural effusion causing significant collapse and precluding proper visualization of underlying lung.
• Conditions that may interfere with lung ultrasound quality or probe contact such as marked obesity, severe chest wall deformities, burns or wounds.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Marchioni A, Castaniere I, Tonelli R, Fantini R, Fontana M, Tabbi L, Viani A, Giaroni F, Ruggieri V, Cerri S, Clini E. Ultrasound-assessed diaphragmatic impairment is a predictor of outcomes in patients with acute exacerbation of chronic obstructive pulmonary disease undergoing noninvasive ventilation. Crit Care. 2018 Apr 27;22(1):109. doi: 10.1186/s13054-018-2033-x.

  PMID: 29703214 BACKGROUND

• Biasucci DG, Buonsenso D, Piano A, Bonadia N, Vargas J, Settanni D, Bocci MG, Grieco DL, Carnicelli A, Scoppettuolo G, Eleuteri D, DE Pascale G, Pennisi MA, Franceschi F, Antonelli M; Gemelli Against COVID-19 Group. Lung ultrasound predicts non-invasive ventilation outcome in COVID-19 acute respiratory failure: a pilot study. Minerva Anestesiol. 2021 Sep;87(9):1006-1016. doi: 10.23736/S0375-9393.21.15188-0. Epub 2021 Jul 14.

  PMID: 34263580 BACKGROUND

Related Links

• Related Info
• Related Info

Central Study Contacts

Mona Zakria Hassab Elnabi, resident doctor

CONTACT

+201145682833; mony.zak05@gmail.com

Hend Mohamed Sayed, lecturer

CONTACT

01098988712; hend.m.saleh@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor Principal investigator

Study Record Dates

• First Submitted: October 5, 2024
• First Posted: November 7, 2024
• Study Start: November 20, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 7, 2024

Record last verified: 2024-10