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Clinical Trials/NCT03281785
NCT03281785
Completed
Not Applicable

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

Mansoura University1 site in 1 country93 target enrollmentSeptember 20, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mechanical Ventilation
Sponsor
Mansoura University
Enrollment
93
Locations
1
Primary Endpoint
Diaphragmatic thickness
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 20, 2017
End Date
March 1, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiologists (ASA) physical status grades I and II.
  • Glasgow coma scale \<
  • 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.

Outcomes

Primary Outcomes

Diaphragmatic thickness

Time Frame: for 3 weeks after initiation of mechanical ventilation

changes in diaphragmatic thickness from baseline to nadir

Secondary Outcomes

  • Complete blood picture(for 3 weeks after admission to the ICU)
  • Arterial Oxygen Saturation(for 3 weeks after admission to the ICU)
  • mode of ventilation(for 3 weeks after initiation of mechanical ventilation)
  • tidal volume(for 3 weeks after initiation of mechanical ventilation)
  • Liver function(for 3 weeks after admission to the ICU)
  • Glasgow coma scale (GCS)(for 2 weeks after initiation of mechanical ventilation.)
  • Mean blood pressure(for 3 weeks after admission to the ICU)
  • Heart rate(for 3 weeks after admission to the ICU)
  • Central Venous Pressure(for 3 weeks after admission to the ICU)
  • The relation between time of mechanical ventilation and the percentage of change of diaphragmatic thickness(for 3 weeks after initiation of mechanical ventilation)
  • Sequential organ failure assessment (SOFA) score(for 3 weeks after admission to the ICU)
  • Renal function tests(for 3 weeks after admission to the ICU)
  • Coagulation profile(for 3 weeks after admission to the ICU)
  • temperature(for 3 weeks after admission to the ICU)
  • respiratory rate(for 3 weeks after initiation of mechanical ventilation)
  • airway pressure(for 3 weeks after initiation of mechanical ventilation)
  • ICU stay(for 3 weeks after initiation of mechanical ventilation)
  • Duration of mechanical ventilation(for 3 weeks after initiation of mechanical ventilation)

Study Sites (1)

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