Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Mina Adolf Helmy, Cairo University

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)

Condition or disease Intervention/treatment Phase
Diaphragmatic Ultrasound in Weaning Device: diaphragmatic ultrasound Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
No Intervention: Group S

weaning readiness will be evaluated with the standard criteria :- A) Clinical assessment:-

  • Resolution of acute phase of disease for which patient was intubated
  • Adequate cough
  • Absence of excessive tracheobronchial secretions

B) Objective criteria:-

  • Adequate oxygenation:PaO2>60mmHg with PEEP<8,SaO2>90%,FIO2 <0.5,PaO2/FIO2>200
  • Respiratory rate <30
  • PH and PaCO2 appropriate for patients' baseline respiratory status
  • Hemodynamically stable :minimal or no vasopressor/inotropes,no evidence of myocardial ischemia
  • HR<140 beats/minute
  • Patient is arousable or Glasgow coma scale (GCS)>13
Experimental: Group SD

weaning readiness will be evaluated with the following criteria:- A) Clinical assessment:-

  • Resolution of acute phase of disease for which patient was intubated
  • Adequate cough
  • Absence of excessive tracheobronchial secretions

B) Objective criteria:-

  • Adequate oxygenation:PaO2>60mmHg with PEEP<8,SaO2>90%,FIO2 <0.5,PaO2/FIO2>200
  • Respiratory rate <30
  • PH and PaCO2 appropriate for patients' baseline respiratory status
  • Hemodynamically stable :minimal or no vasopressor/inotropes,no evidence of myocardial ischemia
  • HR<140 beats/minute
  • Patient is arousable or Glasgow coma scale (GCS)>13

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).




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Locations
Layout table for location information
Egypt
Cairo University-Manial
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
Layout table for investigator information
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
Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Mina Adolf Helmy, Doctor, Cairo University
ClinicalTrials.gov Identifier: NCT03608332    
Other Study ID Numbers: DUS in weaning
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No