Ultrasound of Diaphragmatic Musculature in Mechanically Ventilated Patients.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mechanical Ventilation

Intervention / Treatment
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* Other: Pressure controlled mandatory ventilation mode (P-CMV)
* Other: Pressure synchronized intermittent mandatory ventilation
* Other: Pressure support mode (PS)


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pressure controlled mandatory ventilation mode (P-CMV)<br>Patients will be ventilated using pressure controlled mandatory ventilation mode | Other: Pressure controlled mandatory ventilation mode (P-CMV)<br>* Pressure controlled mandatory ventilation mode (P-CMV)<br>|
| Active Comparator: Pressure synchronized intermittent mandatory ventilation<br>Patients will be ventilated using pressure synchronized intermittent mandatory ventilation mode (P-SIMV) | Other: Pressure synchronized intermittent mandatory ventilation<br>* Pressure synchronized intermittent mandatory ventilation<br>|
| Active Comparator: Pressure support mode (PS)<br>Patents will be ventilated with pressure support mode (PS) | Other: Pressure support mode (PS)<br>* Pressure support mode (PS)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragmatic thickness | changes in diaphragmatic thickness from baseline to nadir | for 3 weeks after initiation of mechanical ventilation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relation between time of mechanical ventilation and the percentage of change of diaphragmatic thickness | measurement of the diaphragmatic thickness as usual and calculate the percentage of change of the diaphragmatic thickness over the time of mechanical ventilation | for 3 weeks after initiation of mechanical ventilation | 
| Glasgow coma scale (GCS) |  | for 2 weeks after initiation of mechanical ventilation. | 
| Sequential organ failure assessment (SOFA) score |  | for 3 weeks after admission to the ICU | 
| Complete blood picture |  | for 3 weeks after admission to the ICU | 
| Coagulation profile |  | for 3 weeks after admission to the ICU | 
| Liver function |  | for 3 weeks after admission to the ICU | 
| Renal function tests |  | for 3 weeks after admission to the ICU | 
| Mean blood pressure |  | for 3 weeks after admission to the ICU | 
| Heart rate |  | for 3 weeks after admission to the ICU | 
| Arterial Oxygen Saturation |  | for 3 weeks after admission to the ICU | 
| Central Venous Pressure |  | for 3 weeks after admission to the ICU | 
| temperature |  | 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 | 
| respiratory rate |  | for 3 weeks after initiation of mechanical ventilation | 
| airway pressure | peak and mean airway pressure | for 3 weeks after initiation of mechanical ventilation | 
| ICU stay | Time from admission to the ICU untill discharge or death | for 3 weeks after initiation of mechanical ventilation | 
| Duration of mechanical ventilation | time from initiation of mechanical ventilation till extubation or death | for 3 weeks after initiation of mechanical ventilation |