Ultrasound of Diaphragmatic Musculature in Mechanically Ventilated Patients.

March 26, 2019 updated by: Mansoura University

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

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

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • DK
      • Mansourah, DK, Egypt, 050
        • mansoura university, faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2017

Primary Completion (Actual)

September 30, 2018

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

September 11, 2017

First Submitted That Met QC Criteria

September 11, 2017

First Posted (Actual)

September 13, 2017

Study Record Updates

Last Update Posted (Actual)

March 28, 2019

Last Update Submitted That Met QC Criteria

March 26, 2019

Last Verified

March 1, 2019

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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