Clinical trial NCT03608332: Diaphragmatic Ultrasound as a Guide Tool During Weaning From Mechanical Ventilation
Official title: Diaphragmatic Ultrasound as a Guide Tool During Weaning From Mechanical Ventilation (Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diaphragmatic Ultrasound in Weaning
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Success rate of weaning from mechanical ventilation in both groups
timeFrame: 48 Hours after weaning
Secondary outcomes:
measure: • Rapid shallow breathing index (RSBI) and its correlation with ultrasound derived variables
timeFrame: baseline
measure: • Days of ventilation (before weaning trial) in correlation to diaphragmatic dysfunction
timeFrame: baseline
measure: • Number of weaning trials prior to inclusion in the study
timeFrame: baseline
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University-Manial
Study officials:
affiliation: professor of anesthesiology cairo university
name: ahmed mohamed moukhtar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: professor of anesthesiology cairo university
name: waleed ibrahim Hamimmy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: assistant professor of anesthesiology cairo university
name: akram shahat Eladawy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: lecturer of anesthesiology cairo university
name: ahmed muhamed lotfy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: assistant lecturer of anesthesiology cairo university
name: mina adolf helmy, MSc
role: PRINCIPAL_INVESTIGATOR
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