- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03281785
Ultrasound of Diaphragmatic Musculature in Mechanically Ventilated Patients.
Ultrasound Evaluation of the Diaphragmatic Musculature in Mechanically Ventilated Patients in Intensive Care Unit
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
DK
-
Mansourah, DK, Egypt, 050
- mansoura university, faculty of medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Pressure controlled mandatory ventilation mode (P-CMV)
Patients will be ventilated using pressure controlled mandatory ventilation mode
|
Pressure controlled mandatory ventilation mode (P-CMV)
|
Active Comparator: Pressure synchronized intermittent mandatory ventilation
Patients will be ventilated using pressure synchronized intermittent mandatory ventilation mode (P-SIMV)
|
Pressure synchronized intermittent mandatory ventilation
|
Active Comparator: Pressure support mode (PS)
Patents will be ventilated with pressure support mode (PS)
|
Pressure support mode (PS)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diaphragmatic thickness
Time Frame: for 3 weeks after initiation of mechanical ventilation
|
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
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
|
for 3 weeks after initiation of mechanical ventilation
|
Glasgow coma scale (GCS)
Time Frame: for 2 weeks after initiation of mechanical ventilation.
|
for 2 weeks after initiation of mechanical ventilation.
|
|
Sequential organ failure assessment (SOFA) score
Time Frame: for 3 weeks after admission to the ICU
|
for 3 weeks after admission to the ICU
|
|
Complete blood picture
Time Frame: for 3 weeks after admission to the ICU
|
for 3 weeks after admission to the ICU
|
|
Coagulation profile
Time Frame: for 3 weeks after admission to the ICU
|
for 3 weeks after admission to the ICU
|
|
Liver function
Time Frame: for 3 weeks after admission to the ICU
|
for 3 weeks after admission to the ICU
|
|
Renal function tests
Time Frame: for 3 weeks after admission to the ICU
|
for 3 weeks after admission to the ICU
|
|
Mean blood pressure
Time Frame: for 3 weeks after admission to the ICU
|
for 3 weeks after admission to the ICU
|
|
Heart rate
Time Frame: for 3 weeks after admission to the ICU
|
for 3 weeks after admission to the ICU
|
|
Arterial Oxygen Saturation
Time Frame: for 3 weeks after admission to the ICU
|
for 3 weeks after admission to the ICU
|
|
Central Venous Pressure
Time Frame: for 3 weeks after admission to the ICU
|
for 3 weeks after admission to the ICU
|
|
temperature
Time Frame: for 3 weeks after admission to the ICU
|
for 3 weeks after admission to the ICU
|
|
mode of ventilation
Time Frame: for 3 weeks after initiation of mechanical ventilation
|
for 3 weeks after initiation of mechanical ventilation
|
|
tidal volume
Time Frame: for 3 weeks after initiation of mechanical ventilation
|
for 3 weeks after initiation of mechanical ventilation
|
|
respiratory rate
Time Frame: for 3 weeks after initiation of mechanical ventilation
|
for 3 weeks after initiation of mechanical ventilation
|
|
airway pressure
Time Frame: for 3 weeks after initiation of mechanical ventilation
|
peak and mean airway pressure
|
for 3 weeks after initiation of mechanical ventilation
|
ICU stay
Time Frame: for 3 weeks after initiation of mechanical ventilation
|
Time from admission to the ICU untill discharge or death
|
for 3 weeks after initiation of mechanical ventilation
|
Duration of mechanical ventilation
Time Frame: for 3 weeks after initiation of mechanical ventilation
|
time from initiation of mechanical ventilation till extubation or death
|
for 3 weeks after initiation of mechanical ventilation
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Amal R Ali, MD, Professor of Anesthesia and Surgical Intensive Care
- Study Director: Hanaa M Elbendary, MD, Professor of Anesthesia and Surgical Intensive Care
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MD%2f16.12.52
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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