Ultrasound of Diaphragmatic Musculature in Mechanically Ventilated Patients.

Mechanical Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03281785
• Other study ID #: MD%2f16.12.52
• Status: Completed
• Phase: N/A
• Start date: September 20, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: March 2019
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: March 1, 2019
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Mechanical Ventilation

Intervention

Other:
• Pressure controlled mandatory ventilation mode (P-CMV)
Pressure controlled mandatory ventilation mode (P-CMV)
• Pressure synchronized intermittent mandatory ventilation
Pressure synchronized intermittent mandatory ventilation
• Pressure support mode (PS)
Pressure support mode (PS)

Locations

Country	Name	City	State
Egypt	Mansoura University, Faculty of Medicine	Mansourah	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaphragmatic thickness	changes in diaphragmatic thickness from baseline to nadir	for 3 weeks after initiation of mechanical ventilation
Secondary	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
Secondary	Glasgow coma scale (GCS)		for 2 weeks after initiation of mechanical ventilation.
Secondary	Sequential organ failure assessment (SOFA) score		for 3 weeks after admission to the ICU
Secondary	Complete blood picture		for 3 weeks after admission to the ICU
Secondary	Coagulation profile		for 3 weeks after admission to the ICU
Secondary	Liver function		for 3 weeks after admission to the ICU
Secondary	Renal function tests		for 3 weeks after admission to the ICU
Secondary	Mean blood pressure		for 3 weeks after admission to the ICU
Secondary	Heart rate		for 3 weeks after admission to the ICU
Secondary	Arterial Oxygen Saturation		for 3 weeks after admission to the ICU
Secondary	Central Venous Pressure		for 3 weeks after admission to the ICU
Secondary	temperature		for 3 weeks after admission to the ICU
Secondary	mode of ventilation		for 3 weeks after initiation of mechanical ventilation
Secondary	tidal volume		for 3 weeks after initiation of mechanical ventilation
Secondary	respiratory rate		for 3 weeks after initiation of mechanical ventilation
Secondary	airway pressure	peak and mean airway pressure	for 3 weeks after initiation of mechanical ventilation
Secondary	ICU stay	Time from admission to the ICU untill discharge or death	for 3 weeks after initiation of mechanical ventilation
Secondary	Duration of mechanical ventilation	time from initiation of mechanical ventilation till extubation or death	for 3 weeks after initiation of mechanical ventilation