The Role of Diaphragmatic Ultrasound as a Predictor of Extubation From Mechanical Ventilation

October 1, 2021 updated by: Ahmed Aelgharib Ahmed, Beni-Suef University

The Role of Diaphragmatic Ultrasound as a Predictor of Successful Extubation From Mechanical Ventilation in Respiratory Intensive Care Unit

Aim: To evaluate real-time ultrasound in the evaluation of diaphragmatic thickening, thickening fraction and or excursion to predict extubation outcomes. The investigators aimed to compare these parameters with other traditional weaning measures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The diaphragm is an important respiratory muscle and dysfunction is very common in patients receiving mechanical ventilation. Diaphragm fatigue occurs even in patients who successfully pass the Spontaneous Breathing Test (SBT). Interrupting ventilation too early can lead to increased cardiovascular and respiratory pressure (CO2).retention and hypoxemia with up to 25% of patients requiring reinstitution of ventilator support. Unnecessary delays in liberation from mechanical ventilation also can be deleterious. Complications such as ventilator-associated pneumonia and ventilator-induced diaphragm atrophy can be seen with short periods of mechanical ventilation thereby prolonging mechanical ventilation. As SBT monitoring is insensitive to detect early signs of load-capacity imbalance. The evaluation of the diaphragmatic thickening fraction (DTF) may be also helpful to assess diaphragmatic function and its contribution to respiratory workload. Ultrasound can be used to detect the deflection of the diaphragm, which helps to identify patients with diaphragm dysfunction

Study Type

Observational

Enrollment (Actual)

120

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
    • Mequbal
      • Banī Suwayf, Mequbal, Egypt
        • Beni-suef

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

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This prospective study was carried out on 40 patients who are mechanically ventilated due to pulmonary disease, 40 patients on mechanical ventilation due to non-pulmonary disease at respiratory ICU and 40Chronic obstructive pulmonary disease (COPD) patients from Outpatient Clinic serving as controls at Embaba Chest Hospital. Cairo, Egypt during a period from January 2018 to November 2019. Written informed consent was obtained from all patients prior to enrollment according to approval at the local committee of Beni-suef University Hospital.

Description

Inclusion Criteria:

  • Critically ill patients intubated for more than 48 hours who are ready for weaning with the following criteria.

    1. positive end-expiratory pressure (PEEP) ≤ 5 cm H2O.
    2. Fraction of inspired oxygen (FiO2) < 0.5.
    3. respiratory rate (RR) < 30 breaths/min.
    4. rapid shallow breathing index < 105, PaO2/FiO2 > 200.
  • Age< 65 years.

Exclusion Criteria:

  • Age<18 years.
  • Patient with history of plural effusion, trauma to chest and history of mechanical ventilation for < 6 months.
  • patient with neuromuscular diseases affect diaphragm .

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group B

40 patients who are mechanically ventilated due to pulmonary disease at respiratory ICU had their diagnosis as follows: 21 (53%) had COPD, 8 (20%) had asthma, 5 (13%) had bronchiectasis, 5 (13%) had pneumonia and

1 (3%) had viral influenza H1N1. Out of group B patients, 11 patients (13.75%) had failed weaning, of which 6 patients needed reintubation and 5 patients needed non-invasive positive ventilation of which 3 patients were re-intubated and 2 patients died.
Device: ultrasound
ultrasound on diaphragm
Group A
40 patients on mechanical ventilation due to non-pulmonary disease at respiratory ICU had their diagnosis as follows: 24 (60%) had congestive heart failure, 4 (10%) had diabetes mellitus, 4 (10%) had sepsis other than pneumonia, 2 (5%) had epilepsy, 2 (5%) had embolic hemiplegia, and 4 (10%) had chronic renal failure. Out of group A patient, 9 patients (11.25%) had failed weaning of which 4 patients needed reintubation and 5 patients needed non-invasive positive ventilation of which 2 patients were reintubated and 3 patients died.
Device: ultrasound
ultrasound on diaphragm
control group.
40 patients Chronic obstructive pulmonary disease (COPD) from Outpatient Clinic
Device: ultrasound
ultrasound on diaphragm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diaphragmatic ultrasound thickening
Time Frame: during weaning from mechanical ventilation 0n T- tube, through study completion, an average of 1 year
Right diaphragmatic ultrasound measurement thickening in millimeter was made during tidal and deep breathing . patient is in the supine position and measurement of right diaphragm by M-mode and B-mode images
during weaning from mechanical ventilation 0n T- tube, through study completion, an average of 1 year
diaphragmatic ultrasound thickening fraction
Time Frame: during weaning from mechanical ventilation 0n T- tube, through study completion, an average of 1 year
Right diaphragmatic ultrasound measurement thickening fraction(percentage% ) was made during tidal and deep breathing . patient is in the supine position and measurement of right diaphragm by M-mode and B-mode images
during weaning from mechanical ventilation 0n T- tube, through study completion, an average of 1 year
diaphragmatic ultrasound excursion
Time Frame: during weaning from mechanical ventilation 0n T- tube, through study completion, an average of 1 year
Right diaphragmatic ultrasound measurement excursion( centimeter) was made during tidal and deep breathing . patient is in the supine position and measurement of right diaphragm by M-mode and B-mode images
during weaning from mechanical ventilation 0n T- tube, through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diaphragmatic ultrasound thickening fraction
Time Frame: Up to 48 hours on T-tube, through study completion, an average of 1 year
Differences in thickening fraction ( millimeter )between patients who are successfully and failed weaning .
Up to 48 hours on T-tube, through study completion, an average of 1 year
diaphragmatic ultrasound thickening
Time Frame: Up to 48 hours on T-tube, through study completion, an average of 1 year
Differences in diaphragm thickening(percentage% )between patients who are successfully and failed weaning .
Up to 48 hours on T-tube, through study completion, an average of 1 year
diaphragmatic ultrasound excursion
Time Frame: Up to 48 hours on T-tube, through study completion, an average of 1 year
Differences in diaphragm excursion ( centimeter) between patients who are successfully and failed weaning
Up to 48 hours on T-tube, through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Beni-Suef University

Investigators

  • Study Director: Randa S Mohamed, professor, Benisuef unviresity

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)

January 1, 2018

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

September 3, 2021

First Submitted That Met QC Criteria

September 21, 2021

First Posted (Actual)

October 1, 2021

Study Record Updates

Last Update Posted (Actual)

October 8, 2021

Last Update Submitted That Met QC Criteria

October 1, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • FMBSUREC/05012020/Ahmed

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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