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Diaphragmatic Ultrasound as a Guide Tool During Weaning From Mechanical Ventilation

Diaphragmatic Ultrasound as a Guide Tool During Weaning From Mechanical Ventilation (Randomized Controlled Trial)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03608332
Enrollment
160
Registered
2018-07-31
Start date
2018-04-30
Completion date
2019-09-29
Last updated
2019-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaphragmatic Ultrasound in Weaning

Brief summary

To assess value of adding ultrasound derived variables to the usual parameters on success rate of weaning from mechanical ventilation in critically ill patients and to validate sensitivity and specificity of ultrasound derived variables (thickening fraction /diaphragmatic excursion)

Detailed description

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.

Interventions

Diaphragmatic excursion; Diaphragmatic movement will be measured with a 3.5-MHz US probe (Mindray machine, DC-N6).

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Critically ill patients intubated for more than 48 hours who are ready for weaning

Exclusion criteria

* • Age \< 18 years * surgical dressings over the right lower rib cage which would preclude ultrasound examination * patients with chest trauma, thoracotomy, diaphragmatic paralysis, diaphragmatic injury and diaphragmatic surgery * patients with neuromuscular diseases ( myasthenia gravis ,Muscular dystrophies ,Multiple sclerosis and Amyotrophic lateral sclerosis)

Design outcomes

Primary

MeasureTime frameDescription
Success rate of weaning from mechanical ventilation in both groups48 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)

Secondary

MeasureTime frame
• Days of ventilation (before weaning trial) in correlation to diaphragmatic dysfunctionbaseline
• Number of weaning trials prior to inclusion in the studybaseline
• Rapid shallow breathing index (RSBI) and its correlation with ultrasound derived variablesbaseline

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026