Clinical trial NCT03281785: Ultrasound of Diaphragmatic Musculature in Mechanically Ventilated Patients.
Official title: Ultrasound Evaluation of the Diaphragmatic Musculature in Mechanically Ventilated Patients in Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 93
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Diaphragmatic thickness
timeFrame: for 3 weeks after initiation of mechanical ventilation
Secondary outcomes:
measure: The relation between time of mechanical ventilation and the percentage of change of diaphragmatic thickness
timeFrame: for 3 weeks after initiation of mechanical ventilation
measure: Glasgow coma scale (GCS)
timeFrame: for 2 weeks after initiation of mechanical ventilation.
measure: Sequential organ failure assessment (SOFA) score
timeFrame: for 3 weeks after admission to the ICU
measure: Complete blood picture
timeFrame: for 3 weeks after admission to the ICU
measure: Coagulation profile
timeFrame: for 3 weeks after admission to the ICU
measure: Liver function
timeFrame: for 3 weeks after admission to the ICU
measure: Renal function tests
timeFrame: for 3 weeks after admission to the ICU
measure: Mean blood pressure
timeFrame: for 3 weeks after admission to the ICU
measure: Heart rate
timeFrame: for 3 weeks after admission to the ICU
measure: Arterial Oxygen Saturation
timeFrame: for 3 weeks after admission to the ICU
measure: Central Venous Pressure
timeFrame: for 3 weeks after admission to the ICU
measure: temperature
timeFrame: for 3 weeks after admission to the ICU
measure: mode of ventilation
timeFrame: for 3 weeks after initiation of mechanical ventilation
measure: tidal volume
timeFrame: for 3 weeks after initiation of mechanical ventilation
measure: respiratory rate
timeFrame: for 3 weeks after initiation of mechanical ventilation
measure: airway pressure
timeFrame: for 3 weeks after initiation of mechanical ventilation
measure: ICU stay
timeFrame: for 3 weeks after initiation of mechanical ventilation
measure: Duration of mechanical ventilation
timeFrame: for 3 weeks after initiation of mechanical ventilation
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University, Faculty of Medicine
state: DK
Study officials:
affiliation: Professor of Anesthesia and Surgical Intensive Care
name: Amal R Ali, MD
role: STUDY_CHAIR
affiliation: Professor of Anesthesia and Surgical Intensive Care
name: Hanaa M Elbendary, MD
role: STUDY_DIRECTOR
References: