Clinical trial NCT05431036: Evaluation of a Combined Model in Predicting Weaning Outcome in Critically Ill Patients.
Official title: Evaluation of a Combined Model of Lung Aeration Score and Diaphragmatic Indices by Transthoracic Ultrasonography in Predicting Weaning Success in Critically Ill Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Weaning Failure
Keywords: LUS
DUS
RSBI
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Detailed description: Assessment of lung aeration and diaphragmatic indices by transthoracic ultrasonography in patients ready to be weaned from mechanical ventilation as predictors of weaning success in critically ill patients .

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria

* 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).

Primary outcomes:
measure: 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.
timeFrame: baseline
measure: Assessment of diaphragmatic thickness by diaphragmatic ultrasonography M-mode in patients ready to be weaned from MV as a predictor of weaning success.
timeFrame: baseline
measure: Assessment of diaphragmatic motion by diaphragmatic ultrasonography M-mode in patients ready to be weaned from MV as a predictor of weaning success.
timeFrame: baseline
Secondary outcomes:
measure: Compare between sonographic lung aeration assessment, diaphragmatic indices and rapid shallow breathing index(RSBI) as predictors for results of weaning from mechanical ventilation(MV)
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: Chest department at Assuit university hospital
name: Alaa M Taghyan, Ass.Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.