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Ultrasound of Diaphragmatic Musculature in Mechanically Ventilated Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03281785
Recruitment Status : Completed
First Posted : September 13, 2017
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Mansoura University

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.


Condition or disease Intervention/treatment Phase
Mechanical Ventilation Other: Pressure controlled mandatory ventilation mode (P-CMV) Other: Pressure synchronized intermittent mandatory ventilation Other: Pressure support mode (PS) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Ultrasound Evaluation of the Diaphragmatic Musculature in Mechanically Ventilated Patients in Intensive Care Unit
Actual Study Start Date : September 20, 2017
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. Diaphragmatic thickness [ Time Frame: for 3 weeks after initiation of mechanical ventilation ]
    changes in diaphragmatic thickness from baseline to nadir


Secondary Outcome Measures :
  1. 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

  2. Glasgow coma scale (GCS) [ Time Frame: for 2 weeks after initiation of mechanical ventilation. ]
  3. Sequential organ failure assessment (SOFA) score [ Time Frame: for 3 weeks after admission to the ICU ]
  4. Complete blood picture [ Time Frame: for 3 weeks after admission to the ICU ]
  5. Coagulation profile [ Time Frame: for 3 weeks after admission to the ICU ]
  6. Liver function [ Time Frame: for 3 weeks after admission to the ICU ]
  7. Renal function tests [ Time Frame: for 3 weeks after admission to the ICU ]
  8. Mean blood pressure [ Time Frame: for 3 weeks after admission to the ICU ]
  9. Heart rate [ Time Frame: for 3 weeks after admission to the ICU ]
  10. Arterial Oxygen Saturation [ Time Frame: for 3 weeks after admission to the ICU ]
  11. Central Venous Pressure [ Time Frame: for 3 weeks after admission to the ICU ]
  12. temperature [ Time Frame: for 3 weeks after admission to the ICU ]
  13. mode of ventilation [ Time Frame: for 3 weeks after initiation of mechanical ventilation ]
  14. tidal volume [ Time Frame: for 3 weeks after initiation of mechanical ventilation ]
  15. respiratory rate [ Time Frame: for 3 weeks after initiation of mechanical ventilation ]
  16. airway pressure [ Time Frame: for 3 weeks after initiation of mechanical ventilation ]
    peak and mean airway pressure

  17. ICU stay [ Time Frame: for 3 weeks after initiation of mechanical ventilation ]
    Time from admission to the ICU untill discharge or death

  18. Duration of mechanical ventilation [ Time Frame: for 3 weeks after initiation of mechanical ventilation ]
    time from initiation of mechanical ventilation till extubation or death



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281785


Locations
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Egypt
Mansoura University, Faculty of Medicine
Mansourah, DK, Egypt, 050
Sponsors and Collaborators
Mansoura University
Investigators
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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
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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT03281785    
Other Study ID Numbers: MD%2f16.12.52
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No