Ultrasound of Diaphragmatic Musculature in Mechanically Ventilated Patients.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-20

Study Completion Date

2019-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Relationship Between Diaphragm Function Assessed by Ultrasound and Weaning Success in Mechanically Ventilated Patients in the ICU

NCT07332403

Weaning Mechanical Ventilation Ultrasonography Intensive Care (ICU) +2 more

COMPLETED

Diaphragm Ultrasound Vs Transpulmonary Pressure To Set PEEP in ARDS

NCT02463773

Acute Respiratory Distress Syndrome Acute Respiratory Failure

COMPLETED NA

Ultrasound Diagnostic for Diaphragmatic Dysfunction in Reanimation

NCT02883465

Mechanical Ventilation Weaning

COMPLETED NA

Cardiopulmonary Changes Prolonged Surgical Abdominal Retractors Application in Supine Versus Lateral Position

NCT03776292

Cardio-pulmonary

COMPLETED

Ultrasound Study of the Diaphragm Evolution Under ECMO

NCT03736239

Cardiogenic Shock Weaning Failure

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mechanical Ventilation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pressure controlled mandatory ventilation mode (P-CMV)

Patients will be ventilated using pressure controlled mandatory ventilation mode

Group Type ACTIVE_COMPARATOR

Pressure controlled mandatory ventilation mode (P-CMV)

Intervention Type OTHER

Pressure controlled mandatory ventilation mode (P-CMV)

Pressure synchronized intermittent mandatory ventilation

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

Group Type ACTIVE_COMPARATOR

Pressure synchronized intermittent mandatory ventilation

Intervention Type OTHER

Pressure synchronized intermittent mandatory ventilation

Pressure support mode (PS)

Patents will be ventilated with pressure support mode (PS)

Group Type ACTIVE_COMPARATOR

Pressure support mode (PS)

Intervention Type OTHER

Pressure support mode (PS)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pressure controlled mandatory ventilation mode (P-CMV)

Intervention Type OTHER

Pressure synchronized intermittent mandatory ventilation

Intervention Type OTHER

Pressure support mode (PS)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No