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CompletedNCT03281785Updated Mar 28, 2019

Ultrasound of Diaphragmatic Musculature in Mechanically Ventilated Patients.

An interventional study of Pressure controlled mandatory ventilation mode (P-CMV) and Pressure synchronized intermittent mandatory ventilation in Mechanical Ventilation, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to male participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-03-28.

Sponsored by Mansoura University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
93
Allocation
Non-randomized
Ages
20 Years to 40 Years
Sex
Male
01

Study 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.

Read the 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.
02

Conditions studied

  • Mechanical Ventilation
03

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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).
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
93 participants (actual)

Study arms

  • 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)

  • 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

  • Active comparator
    Pressure support mode (PS)

    Patents will be ventilated with pressure support mode (PS)

    Other: Pressure support mode (PS)

Interventions

  • OtherPressure controlled mandatory ventilation mode (P-CMV)

    Pressure controlled mandatory ventilation mode (P-CMV)

  • OtherPressure synchronized intermittent mandatory ventilation

    Pressure synchronized intermittent mandatory ventilation

  • OtherPressure support mode (PS)

    Pressure support mode (PS)

05

What researchers measure

Primary outcomes

  1. Diaphragmatic thickness

    changes in diaphragmatic thickness from baseline to nadir

    Time frame: for 3 weeks after initiation of mechanical ventilation

Secondary outcomes

  1. 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

    Time frame: for 3 weeks after initiation 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

    peak and mean airway pressure

    Time frame: for 3 weeks after initiation of mechanical ventilation

  17. ICU stay

    Time from admission to the ICU untill discharge or death

    Time frame: for 3 weeks after initiation of mechanical ventilation

  18. Duration of mechanical ventilation

    time from initiation of mechanical ventilation till extubation or death

    Time frame: for 3 weeks after initiation of mechanical ventilation

06

Study locations

1 site
  • Mansoura University, Faculty of Medicine
    Mansourah, DK 050, Egypt
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03281785
Lead sponsor
Mansoura University
Responsible party
Sponsor
First posted
Sep 13, 2017
Start date
Sep 20, 2017
Primary completion
Sep 30, 2018
Completion
Mar 1, 2019
Last update
Mar 28, 2019

Study contacts

Amal R Ali, MD
study chair · Professor of Anesthesia and Surgical Intensive Care
Hanaa M Elbendary, MD
study director · Professor of Anesthesia and Surgical Intensive Care

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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