Evaluation of a Combined Model in Predicting Weaning Outcome in Critically Ill Patients.

NCT05431036 | Unknown

• 1 other identifier: lung US in ICU patient
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of our study is to assess lung aeration and diaphragmatic indices by transthoracic ultrasonography in patients ready to be weaned from mechanical ventilation as predictors of weaning success

Conditions

Weaning Failure

Keywords

LUS; DUS; RSBI

Outcome Measures

Primary Outcomes (3)

• Assessment of lung aeration by lung ultrasound score using MEDESION SONOACE R3 portable ultrasound apparatus in patients ready to be weaned from mechanical ventilation (MV) as a predictor of weaning success.

  The lung ultrasound score (LUS) will be calculated according to the observed worst ultrasound pattern using the convex probe (MEDESION SONOACE R3 portable ultrasound, Korea 2010). (normal aeration, LUS = 0);( moderate loss of lung aeration (multiple, well-defined B lines), LUS = 1);( severe loss of lung aeration (multiple coalescent B lines), LUS = 2); (lung consolidation, LUS = 3).Finally, the LUSs of all the parts will added to obtain the total LUS for each patient (maximum36 points).

  baseline

• Assessment of diaphragmatic thickness by diaphragmatic ultrasonography M-mode in patients ready to be weaned from MV as a predictor of weaning success.

  The diaphragmatic ultrasound will performed for assessment of diaphragmatic thickness by M-Mode Using the high frequency linear probe of 7.5 MHz.This will done in serial manner beginning 24 hours after RICU admission,then during spontaneous breathing trial till the patient is liberated from mechanical ventilation. DT difference (DTD) will be calculated by subtracting The Diaphragm thickening fraction (DTF) will calculated as: DTD/(DT at end-expiration) × 100%

  baseline

• Assessment of diaphragmatic motion by diaphragmatic ultrasonography M-mode in patients ready to be weaned from MV as a predictor of weaning success.

  The diaphragmatic ultrasound will performed for assessment of diaphragmatic motion by M-mode using the curvilinear low frequency probe (5 MHz).This will done in serial manner beginning 24 hours after RICU admission,then during spontaneous breathing trial till the patient is liberated from mechanical ventilation. Diaphragmatic excursion (DE) will identified and measured. DE amplitude will measured on the vertical axis by tracing from the baseline to the point of maximum height of inspiration on the graph.

  baseline

Secondary Outcomes (1)

• Compare between sonographic lung aeration assessment, diaphragmatic indices and rapid shallow breathing index(RSBI) as predictors for results of weaning from mechanical ventilation(MV)

  baseline

Interventions

transthoracic ultrasonography DEVICE

1. The lung ultrasound score (LUS) will be calculated according to the observed worst ultrasound pattern and Finally, the LUSs of all the parts will added to obtain the total LUS for each patient (maximum36 points) 2. The diaphragmatic ultrasound will performed for assessment of diaphragmatic thickness and motion.

Eligibility Criteria

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

Study Population

The study group will be mechanically ventilated for at least 48 hours. Patients will be assessed daily for fulfillment of criteria of readiness to wean according to European Respiratory Society guidelines and assessment of the three parameters which is Rapid shallow breathing index ( RSBI), lung ultrasound score( LUS) and Diaphragmatic ultrasound (DUS) will be done for predicting weaning success.

You may qualify if:

• Patients more than18 years old.
• All patients intubated and requiring mechanical ventilation for 48 hours or more at respiratory intensive care unit (RICU)
• Patients fullfiled the criteria of readiness to wean according to European Respiratory Society guidelines (ERS)

You may not qualify if:

• Patients with neuromuscular disease or diaphragmatic paralysis.
• Patients with tracheostomy.
• Patients who undergone surgical operations especially abdominal and thoracic operation.
• Patients with diseases that may affect the diaphragm (including pneumothorax, pneumomediastinum, patients with inserted intercostal tube (ICT), third trimester of pregnancy).

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24.

  PMID: 23344830 BACKGROUND

• Soummer A, Perbet S, Brisson H, Arbelot C, Constantin JM, Lu Q, Rouby JJ; Lung Ultrasound Study Group. Ultrasound assessment of lung aeration loss during a successful weaning trial predicts postextubation distress*. Crit Care Med. 2012 Jul;40(7):2064-72. doi: 10.1097/CCM.0b013e31824e68ae.

  PMID: 22584759 BACKGROUND

• Li S, Chen Z, Yan W. Application of bedside ultrasound in predicting the outcome of weaning from mechanical ventilation in elderly patients. BMC Pulm Med. 2021 Jul 9;21(1):217. doi: 10.1186/s12890-021-01605-4.

  PMID: 34243739 BACKGROUND

Study Officials

• Alaa M Taghyan, Ass.Lecturer

  Chest department at Assuit university hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaa M Taghyan, master

CONTACT

01093093050; alaataghyan@gmail.com

Gamal M Rabee Agamy, Professor

CONTACT

01155213224; Gamalagmy135@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer, chest department,Principal Investigator,Clinical Professor

Study Record Dates

• First Submitted: June 12, 2022
• First Posted: June 24, 2022
• Study Start: November 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share