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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
93

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Egypt
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Pressure controlled mandatory ventilation mode (P-CMV)
Patients will be ventilated using pressure controlled mandatory ventilation mode
Other: Pressure controlled mandatory ventilation mode (P-CMV)
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)
Other: Pressure synchronized intermittent mandatory ventilation
Pressure synchronized intermittent mandatory ventilation
Active Comparator: Pressure support mode (PS)
Patents will be ventilated with pressure support mode (PS)
Other: Pressure support mode (PS)
Pressure support mode (PS)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mansoura University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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