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Completed

NCT Number: NCT05063526

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

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.

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Key information

Conditions

Diaphragm Ultrasound

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beni-suef

Banī Suwayf, Mequbal, Egypt

About this study

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

Who can participate

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 with the following criteria.
  • positive end-expiratory pressure (PEEP) ≤ 5 cm H2O.
  • Fraction of inspired oxygen (FiO2) < 0.5.
  • respiratory rate (RR) < 30 breaths/min.
  • 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 .

Treatment and study plan

Ultrasound

Device

ultrasound on diaphragm

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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 .

  2. 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 .

  3. 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

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Oct 1, 2021
Registry last updated
Oct 8, 2021

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.

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