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Ultrasound of Diaphragmatic Musculature in Mechanically Ventilated Patients.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03281785
Enrollment
93
Registered
2017-09-13
Start date
2017-09-20
Completion date
2019-03-01
Last updated
2019-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation

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.

Interventions

OTHERPressure controlled mandatory ventilation mode (P-CMV)

Pressure controlled mandatory ventilation mode (P-CMV)

OTHERPressure synchronized intermittent mandatory ventilation

Pressure synchronized intermittent mandatory ventilation

OTHERPressure support mode (PS)

Pressure support mode (PS)

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
20 Years to 40 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Diaphragmatic thicknessfor 3 weeks after initiation of mechanical ventilationchanges in diaphragmatic thickness from baseline to nadir

Secondary

MeasureTime frameDescription
respiratory ratefor 3 weeks after initiation of mechanical ventilation
airway pressurefor 3 weeks after initiation of mechanical ventilationpeak and mean airway pressure
Arterial Oxygen Saturationfor 3 weeks after admission to the ICU
Central Venous Pressurefor 3 weeks after admission to the ICU
temperaturefor 3 weeks after admission to the ICU
mode of ventilationfor 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 ventilationmeasurement of the diaphragmatic thickness as usual and calculate the percentage of change of the diaphragmatic thickness over the time of mechanical ventilation
Glasgow coma scale (GCS)for 2 weeks after initiation of mechanical ventilation.
tidal volumefor 3 weeks after initiation of mechanical ventilation
Complete blood picturefor 3 weeks after admission to the ICU
Coagulation profilefor 3 weeks after admission to the ICU
Liver functionfor 3 weeks after admission to the ICU
Renal function testsfor 3 weeks after admission to the ICU
Mean blood pressurefor 3 weeks after admission to the ICU
Heart ratefor 3 weeks after admission to the ICU
ICU stayfor 3 weeks after initiation of mechanical ventilationTime from admission to the ICU untill discharge or death
Duration of mechanical ventilationfor 3 weeks after initiation of mechanical ventilationtime from initiation of mechanical ventilation till extubation or death
Sequential organ failure assessment (SOFA) scorefor 3 weeks after admission to the ICU

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026