NCT03281785

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

September 20, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

September 11, 2017

Last Update Submit

March 26, 2019

Conditions

Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

  • Diaphragmatic thickness

    changes in diaphragmatic thickness from baseline to nadir

    for 3 weeks after initiation of mechanical ventilation

Secondary Outcomes (18)

  • The relation between time of mechanical ventilation and the percentage of change of diaphragmatic thickness

    for 3 weeks after initiation of mechanical ventilation

  • Glasgow coma scale (GCS)

    for 2 weeks after initiation of mechanical ventilation.

  • Sequential organ failure assessment (SOFA) score

    for 3 weeks after admission to the ICU

  • Complete blood picture

    for 3 weeks after admission to the ICU

  • Coagulation profile

    for 3 weeks after admission to the ICU

  • +13 more secondary outcomes

Study Arms (3)

Pressure controlled mandatory ventilation mode (P-CMV)

ACTIVE COMPARATOR

Patients will be ventilated using pressure controlled mandatory ventilation mode

Other: Pressure controlled mandatory ventilation mode (P-CMV)

Pressure synchronized intermittent mandatory ventilation

ACTIVE COMPARATOR

Patients will be ventilated using pressure synchronized intermittent mandatory ventilation mode (P-SIMV)

Other: Pressure synchronized intermittent mandatory ventilation

Pressure support mode (PS)

ACTIVE COMPARATOR

Patents will be ventilated with pressure support mode (PS)

Other: Pressure support mode (PS)

Interventions

Pressure controlled mandatory ventilation mode (P-CMV)OTHER

Pressure controlled mandatory ventilation mode (P-CMV)

Pressure controlled mandatory ventilation mode (P-CMV)
Pressure synchronized intermittent mandatory ventilationOTHER

Pressure synchronized intermittent mandatory ventilation

Pressure synchronized intermittent mandatory ventilation
Pressure support mode (PS)OTHER

Pressure support mode (PS)

Pressure support mode (PS)

Eligibility Criteria

Age20 Years - 40 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University, Faculty of Medicine

Al Mansurah, DK, 050, Egypt

Location

Study Officials

  • Amal R Ali, MD

    Professor of Anesthesia and Surgical Intensive Care

    STUDY CHAIR

  • Hanaa M Elbendary, MD

    Professor of Anesthesia and Surgical Intensive Care

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2017

First Posted

September 13, 2017

Study Start

September 20, 2017

Primary Completion

September 30, 2018

Study Completion

March 1, 2019

Last Updated

March 28, 2019

Record last verified: 2019-03

Locations

EG(1)