Diaphragmatic Ultrasound as a Guide Tool During Weaning From Mechanical Ventilation

September 29, 2019 updated by: Mina Adolf Helmy, Cairo University

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

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University-Manial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
48 Hours after weaning

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
• Rapid shallow breathing index (RSBI) and its correlation with ultrasound derived variables
Time Frame: baseline
baseline
• Days of ventilation (before weaning trial) in correlation to diaphragmatic dysfunction
Time Frame: baseline
baseline
• Number of weaning trials prior to inclusion in the study
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 29, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 29, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DUS in weaning

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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