Image

How Early Mobilization Impacts on Diaphragm Thickness in Critically Ill Children

How Early Mobilization Impacts on Diaphragm Thickness in Critically Ill Children

Recruiting
6-12 years
All
Phase N/A

Powered by AI

Overview

The objective is to compare the impact of early mobilization and routine care on diaphragm thickness in critically ill children

Description

Mechanical ventilation is a life-supporting therapy that intrinsically induces diaphragm rest. Consequently, mechanical ventilation induces time-dependent diaphragm weakness in animals and in critically ill patients, and is referred to as ventilator-induced diaphragm dysfunction (VIDD).

In most cases with VIDD, the decrease in diaphragm thickness can be detected by bedside Ultrasonography. The onset of diaphragm atrophy in the intensive care unit could be very rapid (fewer than 5 days). Vivier E. defined muscle atrophy as greater than or equal to a 10% decrease in muscle thickness on day 5 compared to day 1. It's found that diaphragm atrophy occured in 17/35 (48%). However, There is always some cases presented an increase in diaphragm thickness. Goligher EC. reported that approximately 20% of mechanically ventilated patients exhibit an increase in diaphragm thickness. In our previous study, there were about 46.7%(14/30) of ventilated children had increased diaphragmatic thickness. It's supposed that the thickening might associated with the diaphragm injury during mechanical ventilation.

Early mobilization may enhance the weaning of ventilated children, so the investigators hypothesize that the percentile of cases with increase diaphragmatic thickness will decline by early mobilization. To investigate this hypothesis, investigators are conducting a randomized trial examining the effects of early mobilization versus routine care on changing tendency of diaphragm thickness.

Enrolled children requiring mechanical ventilation will be randomized to either early mobilization group or routine care group. Diaphragm thickness will be measured by ultrasound on day1, day3, day5 and day7 after intubation and subsequently diaphragm thickness changing tendency will be calculated in each arm. The operator acquiring ultrasound images will be blinded to the care mode that the subject was randomized to. Subjects in the study will follow standard ICU sedation awakening trials and spontaneous breathing trials. The medical team in charge of the subject will determine when the subject is safe to receive early mobilization according to the standard established along with the rehabilitation team.

Eligibility

Inclusion Criteria:

  • subjects > 6 months and < 12 years of ageļ¼›
  • subjects been intubated and mechanically ventilated for < 24 hours at the time of screening;
  • the Glasgow Coma Scale (GCS) on admission of Pediatric Intensive Care Unit (PICU) is greater than 3

Exclusion Criteria:

  • cardiopulmonary arrest;
  • history of diaphragmatic paralysis or neuromuscular disease;
  • neuromuscular blockade;
  • expectation to be liberated from ventilator in < 24 hours
  • history of mechanical ventilation in the last 6 months
  • presence of tracheostomy
  • high cervical spine injury
  • status convulsion
  • thoracic trauma when ultrasonic examination cannot be performed

Study details
    Mechanical Ventilation Complication
    Ventilator-induced Diaphragm Dysfunction

NCT04534296

Children's Hospital of Fudan University

26 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.