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Ultrasound of Diaphragmatic Musculature in Mechanically Ventilated Patients.

Not Applicable
Completed
Conditions
Mechanical Ventilation
Interventions
Other: Pressure support mode (PS)
Other: Pressure controlled mandatory ventilation mode (P-CMV)
Other: Pressure synchronized intermittent mandatory ventilation
Registration Number
NCT03281785
Lead Sponsor
Mansoura University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
93
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).

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Pressure support mode (PS)Pressure support mode (PS)Patents will be ventilated with pressure support mode (PS)
Pressure controlled mandatory ventilation mode (P-CMV)Pressure controlled mandatory ventilation mode (P-CMV)Patients will be ventilated using pressure controlled mandatory ventilation mode
Pressure synchronized intermittent mandatory ventilationPressure synchronized intermittent mandatory ventilationPatients will be ventilated using pressure synchronized intermittent mandatory ventilation mode (P-SIMV)
Primary Outcome Measures
NameTimeMethod
Diaphragmatic thicknessfor 3 weeks after initiation of mechanical ventilation

changes in diaphragmatic thickness from baseline to nadir

Secondary Outcome Measures
NameTimeMethod
Liver functionfor 3 weeks after admission to the ICU
Glasgow coma scale (GCS)for 2 weeks after initiation of mechanical ventilation.
Mean blood pressurefor 3 weeks after admission to the ICU
Heart ratefor 3 weeks after admission to the ICU
Central Venous Pressurefor 3 weeks after admission to the ICU
mode of ventilationfor 3 weeks after initiation of mechanical ventilation
tidal volumefor 3 weeks after initiation of mechanical ventilation
The relation between time of mechanical ventilation and the percentage of change of diaphragmatic thicknessfor 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

Sequential organ failure assessment (SOFA) scorefor 3 weeks after admission to the ICU
Renal function testsfor 3 weeks after admission to the ICU
Coagulation profilefor 3 weeks after admission to the ICU
temperaturefor 3 weeks after admission to the ICU
respiratory ratefor 3 weeks after initiation of mechanical ventilation
airway pressurefor 3 weeks after initiation of mechanical ventilation

peak and mean airway pressure

ICU stayfor 3 weeks after initiation of mechanical ventilation

Time from admission to the ICU untill discharge or death

Duration of mechanical ventilationfor 3 weeks after initiation of mechanical ventilation

time from initiation of mechanical ventilation till extubation or death

Complete blood picturefor 3 weeks after admission to the ICU
Arterial Oxygen Saturationfor 3 weeks after admission to the ICU

Trial Locations

Locations (1)

Mansoura University, Faculty of Medicine

🇪🇬

Mansourah, DK, Egypt

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