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OpenTrials
Completed

NCT Number: NCT03608332

Diaphragmatic Ultrasound as a Guide Tool During Weaning From Mechanical Ventilation

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)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University-Manial

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

diaphragmatic ultrasound

Device

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. • Rapid shallow breathing index (RSBI) and its correlation with ultrasound derived variables

    Time frame: baseline

  2. • Days of ventilation (before weaning trial) in correlation to diaphragmatic dysfunction

    Time frame: baseline

  3. • Number of weaning trials prior to inclusion in the study

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 31, 2018
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.