Diaphragmatic Ultrasound as a Guide Tool During Weaning From Mechanical Ventilation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03608332|
Recruitment Status : Completed
First Posted : July 31, 2018
Last Update Posted : October 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diaphragmatic Ultrasound in Weaning||Device: diaphragmatic ultrasound||Not Applicable|
Difficult weaning from mechanical ventilation (MV) is a common problem in critically ill patients. Many parameters have been developed to aid weaning from MV such as P/F ratio (PO2/FiO2) and rapid shallow breathing index (respiratory rate/tidal volume), however, sensitivity and specificity for most variables are still variable in literature.
Multiple studies have found that patients tolerantof SBTs were found to have successful discontinuationsat least 77% of the time.
Causes of weaning failure include: airway and lung dysfunction, brain dysfunction, cardiac dysfunction, diaphragm dysfunction, and endocrine dysfunction .
Diaphragmatic dysfunction is a common cause of weaning failure , however most of the traditional methods used for evaluation of diaphragmatic function (fluoroscopy, trans-diaphragmatic pressure measurement) are invasive and not available.
Ultrasound assessment of diaphragmatic function has been developed recently providing an easy and safe method for evaluation of diaphragmatic excursion and thickening.
It was found that weaning failure (Re-intubation within 48 hours) was associated with diaphragmatic excursion <1 cm and thickening fraction <28% several studies reported the value of diaphragmatic ultrasound to predict weaning failure ,however no one of them used diaphragmatic ultrasound to guide weaning.
previous studies showed that failure rate of weaning from mechanical ventilation was 27% ,however failure rate in our department was 43% adding ultrasound derived values aims for improving success rate of weaning from mechanical ventilation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Diaphragmatic Ultrasound as a Guide Tool During Weaning From Mechanical Ventilation (Randomized Controlled Trial)|
|Actual Study Start Date :||April 30, 2018|
|Actual Primary Completion Date :||September 29, 2019|
|Actual Study Completion Date :||September 29, 2019|
No Intervention: Group S
weaning readiness will be evaluated with the standard criteria :- A) Clinical assessment:-
B) Objective criteria:-
Experimental: Group SD
weaning readiness will be evaluated with the following criteria:- A) Clinical assessment:-
B) Objective criteria:-
C) Ultrasound criteria:-
• Diaphragmatic excursion >11 mm
Device: diaphragmatic ultrasound
Diaphragmatic excursion; Diaphragmatic movement will be measured with a 3.5-MHz US probe (Mindray machine, DC-N6).
- Success rate of weaning from mechanical ventilation in both groups [ Time Frame: 48 Hours after weaning ](The trial will be considered a successful weaning trial if the patient passed 48 hours without the need for neither invasive nor non-invasive ventilation)
- • Rapid shallow breathing index (RSBI) and its correlation with ultrasound derived variables [ Time Frame: baseline ]
- • Days of ventilation (before weaning trial) in correlation to diaphragmatic dysfunction [ Time Frame: baseline ]
- • Number of weaning trials prior to inclusion in the study [ Time Frame: baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03608332
|Principal Investigator:||ahmed mohamed moukhtar, MD||professor of anesthesiology cairo university|
|Principal Investigator:||waleed ibrahim Hamimmy, MD||professor of anesthesiology cairo university|
|Principal Investigator:||akram shahat Eladawy, MD||assistant professor of anesthesiology cairo university|
|Principal Investigator:||ahmed muhamed lotfy, MD||lecturer of anesthesiology cairo university|
|Principal Investigator:||mina adolf helmy, MSc||assistant lecturer of anesthesiology cairo university|