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NCT Number: NCT04534296

How Early Mobilization Impacts on Diaphragm Thickness in Critically Ill Children

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

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Key information

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital, Fudan University

Shanghai, China

Location status: Recruiting

Location contact

Sujuan Wang, Dr.

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early mobilization

Other

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.

Routine care

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. the diaphragm thickness

    Time frame: from intubation up to 7 days

    the diaphragm thickness measured by ultrasonography

  2. 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

  3. 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

  4. PICU length of stay

    Time frame: days from admission to discharge from PICU (about 20 days)

    the days when children stayed in PICU

Study contacts

Contact information is provided by the study sponsor or research team.

Sujuan Wang

CONTACT

[email protected]

86-13761000512

Yelin Yao

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 1, 2020
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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