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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chest Infection; Pneumnia; Critically-ill Patients Admitted to the ICU for Acute Respitatory Failure, Regardless the Aetilogy

Detailed Description

Respiratory failure and acute lung injury (ALI) in patients admitted to ICU are major causes of morbidity And mortality As high as 60 % of ICU population dii during their ICU admission due to ALI Accurate assessment of the severity of ALI is Crucial for guiding treatment decisions and predicting patient outcome Reliance on chest X-ray and Computed tomography has its limitations including subjectivity and potential delays in obtaining and interpreting results high cost radiation exposure and lack of continuous monitoring particularly for critically ill patients Ultrasound -being non-invasive low cost radiation free- has been increasingly used as a bedside tool for evaluation and monitoring of ALI However most lung ultrasound protocols published to date are cumbersome and time consuming They typically involve screening at least 12 different lung areas each graded from 0 to 3 point thus generating scores ranging from 0 to 36 .While these scores are informative for research purposes they are less practical in a busy or ICU environment Also disregarding the site of B-lines or consolidation and the size of consolidation potentially under-estimates the severity of ALI Recently a novel -yet comprehensive- point of care ultrasound lung injury score has been developed to aid informative and quick assessment of ALI in ICU PLIS involves screening of only 3 areas but it uniquely considers the level of ventilatory support and gives credit to the number of B lines size of consolidation location of consultation The score reliably predicted to the need of ICU admission in a group off of COVID 19 patients directly correlation with their SOFA scores also predicted ICU mortality in this patient However Wider adoption of PLIS by intensivists dictates evaluation of its performance in a wider ICU population with a variety of underlying diagnoses This study is to verify whether PLIS remains valid for predicting ICU outcomes in patients with acute respiratory failure regardless the etiology type of respiratory failure oxygen requirement level of ventilatory support

• Study Type: Observational
• Enrollment (Estimated): 72

Contacts and Locations

• Study Contact: Name: Mona Zakria Hassab Elnabi, resident doctor; Phone Number: +201145682833; Email: mony.zak05@gmail.com
• Study Contact Backup: Name: Hend Mohamed Sayed, lecturer; Phone Number: 01098988712; Email: hend.m.saleh@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

• 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]

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for Therapy escalation: Ventilatory Support	Binary response (yes or no), to whether the type of ventilatory support (COT-HVNI-NIV-IMV) was escalated or not	60 days
Need for Therapy Escalation: Ventilatory seetings	Binary response (yes or no) to whether change in ventilatory settings (FiO2, IPAP, EPAP, Ti,TVe) was needed	60 days
Need for Therapy Escalation: Medications	Binary response (yes/no) to whether medications like antibiotics, inotropes, sedation, or NMBs, which were not initiated needed to be added or not	60 days

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): November 20, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: October 5, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Estimated): November 7, 2024

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 5, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Acute respiratory failure; LUS; Critically-ill patients
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Critical Illness
• Other Study ID Numbers: Chest US in ICU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No