How Early Mobilization Impacts on Diaphragm Thickness in Critically Ill Children

August 29, 2023 updated by: Children's Hospital of Fudan University

A Randomized Control Trial Comparing the Effects of Early Mobilization and Routine Care on Diaphragmatic Thickness

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Children's Hospital, Fudan University
        • Contact:
          • Sujuan Wang, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 months to 10 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • subjects > 6 months and < 12 years of age；
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early Mobilization Group (EM group)
Early mobilization will be performed in this arm. Critically ill children will be assessed for appropriate activity within 24 hours of intubation. When the safe criteria is met, early mobilization goals will be set according to the children's clinical conditions, developmental maturity, strength and endurance. The detailed mobilization activities include bed repositioning，passive or active range of motion and stretching exercises, passive or active respiratory muscle strengthening, sitting in bed, transfer from lying to sitting at edge of bed. Progressive mobilization goals will be individualized for each subject daily.
Other: early mobilization
Early mobilization is a kind of rehabilitation strategy. When the safe standards are met, early mobilization will be performed on subjects randomized in EM group for 30 minutes each time, twice a day, from Monday to Friday. The detailed mobilization activities include bed repositioning，passive or active range of motion and stretching exercises, passive or active respiratory muscle strengthening, sitting in bed, transfer from lying to sitting at edge of bed. Progressive mobilization goals will be individualized for each subject daily, corresponding to their clinical conditions, developmental maturity, strength and endurance.
Active Comparator: Routine Care Group (RC group)
Routine care strategy without early mobilization will be performed in this arm. It includes the clinical status management, spontaneous breathing trials, choice of sedation and analgesia and routine nursing care including repositioning every 2 hours and bed head elevation.
Other: routine care
In this arm, no additional early rehabilitation interventions will be performed except for the routine clinical care, including the ventilation management, spontaneous breathing trials, choice of sedation and analgesia and routine nursing care including repositioning every 2 hours and bed head elevation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the percentile of cases with increased diaphragm thickness
Time Frame: from intubation up to 7 days
we define the increase of diaphragm thickness as greater than 0 increase in diaphragm thickness on day5 compared to day1
from intubation up to 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the diaphragm thickness
Time Frame: from intubation up to 7 days
the diaphragm thickness measured by ultrasonography
from intubation up to 7 days
diaphragmatic thickening fraction (DTF)
Time Frame: from intubation up to 7 days
the calculation formula of DTF is defined as (Tdi-insp - Tdi-exp)/Tdi-exp x 100
from intubation up to 7 days
mechanical ventilation time
Time Frame: from intubation to the day when children are successfully weaned (about 10 days )
We define the successful weaning as no requirement for reintubation within 48 hours following extubation
from intubation to the day when children are successfully weaned (about 10 days )
PICU length of stay
Time Frame: days from admission to discharge from PICU (about 20 days)
the days when children stayed in PICU
days from admission to discharge from PICU (about 20 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Investigators

  • Study Director: Liyuan Han, Children's Hospital of Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

August 27, 2020

First Submitted That Met QC Criteria

August 27, 2020

First Posted (Actual)

September 1, 2020

Study Record Updates

Last Update Posted (Actual)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • WangSJ001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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