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Completed

NCT Number: NCT03281785

Ultrasound of Diaphragmatic Musculature in Mechanically Ventilated Patients.

Muscle weakness and dysfunction are common problems in patients hospitalized in the intensive care unit. Respiratory muscle weakness during mechanical ventilation was recognized a state of muscular fatigue. The terminology 'ventilator-induced diaphragmatic dysfunction' (VIDD) originally was introduced to describe these effects of mechanical ventilation and respiratory muscle unloading on the diaphragm.

Ultrasonography is becoming increasingly popular management of ICU patients. It is a simple, non-invasive and safe imaging technique that can be used for the assessment of distinctive diaphragmatic characteristics.

Parameters such as amplitude and velocity of contraction, which can be assessed using M-mode ultrasound. In addition, static and dynamic (thickening fraction during inspiration) diaphragmatic thickness can also be measured by ultrasonography.

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Key information

Conditions

Mechanical Ventilation

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University, Faculty of Medicine

Al Mansurah, DK, 050, Egypt

About this study

The aim of this study is to evaluate the effect of different modes of mechanical ventilation on diaphragmatic thickness using ultrasonography and the relation between time of mechanical ventilation and the percentage of change of diaphragmatic thickness in head trauma patients subjected for mechanical ventilation (>2 days) intensive care unit.

Modes of ventilation will be used in the study are:

  • Pressure controlled mandatory ventilation mode (P-CMV).
  • Pressure synchronized intermittent mandatory ventilation mode (P-SIMV).
  • Pressure support (PS) mode.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologists (ASA) physical status grades I and II.
  • Glasgow coma scale < 8.
  • Selections of patients need mechanical ventilation (>2 days).
  • Head trauma patients.

Exclusion criteria

  • History of diaphragmatic disease
  • Neuromuscular disease
  • Anatomical malformation of the diaphragm.
  • Patients with chest disease
  • Diabetic patients.
  • Chest trauma
  • Chest malignancy.
  • Use of non-invasive ventilation before the start of invasive ventilation.
  • Selection of patients of short period of mechanical ventilation (< 2 days).
  • Hemodynamic instability.
  • Morbid obesity (body mass index > 40 kg/m2).

Treatment and study plan

Pressure controlled mandatory ventilation mode (P-CMV)

Other

Pressure controlled mandatory ventilation mode (P-CMV)

Pressure synchronized intermittent mandatory ventilation

Other

Pressure synchronized intermittent mandatory ventilation

Pressure support mode (PS)

Other

Pressure support mode (PS)

Primary outcomes

  1. Diaphragmatic thickness

    Time frame: for 3 weeks after initiation of mechanical ventilation

    changes in diaphragmatic thickness from baseline to nadir

Secondary outcomes

  1. The relation between time of mechanical ventilation and the percentage of change of diaphragmatic thickness

    Time frame: for 3 weeks after initiation of mechanical ventilation

    measurement of the diaphragmatic thickness as usual and calculate the percentage of change of the diaphragmatic thickness over the time of mechanical ventilation

  2. Glasgow coma scale (GCS)

    Time frame: for 2 weeks after initiation of mechanical ventilation.

  3. Sequential organ failure assessment (SOFA) score

    Time frame: for 3 weeks after admission to the ICU

  4. Complete blood picture

    Time frame: for 3 weeks after admission to the ICU

  5. Coagulation profile

    Time frame: for 3 weeks after admission to the ICU

  6. Liver function

    Time frame: for 3 weeks after admission to the ICU

  7. Renal function tests

    Time frame: for 3 weeks after admission to the ICU

  8. Mean blood pressure

    Time frame: for 3 weeks after admission to the ICU

  9. Heart rate

    Time frame: for 3 weeks after admission to the ICU

  10. Arterial Oxygen Saturation

    Time frame: for 3 weeks after admission to the ICU

  11. Central Venous Pressure

    Time frame: for 3 weeks after admission to the ICU

  12. temperature

    Time frame: for 3 weeks after admission to the ICU

  13. mode of ventilation

    Time frame: for 3 weeks after initiation of mechanical ventilation

  14. tidal volume

    Time frame: for 3 weeks after initiation of mechanical ventilation

  15. respiratory rate

    Time frame: for 3 weeks after initiation of mechanical ventilation

  16. airway pressure

    Time frame: for 3 weeks after initiation of mechanical ventilation

    peak and mean airway pressure

  17. ICU stay

    Time frame: for 3 weeks after initiation of mechanical ventilation

    Time from admission to the ICU untill discharge or death

  18. Duration of mechanical ventilation

    Time frame: for 3 weeks after initiation of mechanical ventilation

    time from initiation of mechanical ventilation till extubation or death

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Ultrasound Evaluation of the Diaphragmatic Musculature in Mechanically Ventilated Patients in Intensive Care Unit

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Sep 13, 2017
Registry last updated
Mar 28, 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.

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