Both high level pressure support ventilation and controlled mechanical ventilation induce diaphragm dysfunction and atrophy.
Matthew B Hudson, Ashley J Smuder, W Bradley Nelson...
https://pubmed.ncbi.nlm.nih.gov/22425820Actively Recruiting
Phase Not Applicable
Age: 6Months - 12Years
All Genders
ID04534296
A Randomized Control Trial Comparing the Effects of Early Mobilization and Routine Care on Diaphragmatic Thickness in Critically Ill Children
Led by Children's Hospital of Fudan University · Updated on 2025-02-12
160
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effects of early mobilization versus routine care on diaphragm thickness in critically ill children who require mechanical ventilation. Mechanical ventilation can cause diaphragm weakness known as ventilator-induced diaphragm dysfunction (VIDD), which may develop rapidly and be detected by bedside ultrasound. Early mobilization might reduce cases of increased diaphragm thickness linked to diaphragm injury during ventilation. Children needing mechanical ventilation will be randomly assigned to either an early mobilization group or a routine care group. Early mobilization involves activities like bed repositioning, range of motion exercises, respiratory muscle strengthening, and sitting up, performed twice daily for 30 minutes on weekdays. The routine care group will receive standard clinical management without additional early rehabilitation but includes repositioning and bed head elevation. Participants will have diaphragm thickness measured by ultrasound on days 1, 3, 5, and 7 after intubation. The study team will monitor the changes in diaphragm thickness while following standard sedation awakening and spontaneous breathing trials. Researchers will assess outcomes such as the percentage of cases with increased diaphragm thickness, diaphragm thickness over time, ventilation duration, and length of stay in the pediatric ICU. The study lasts about 20 days, including intensive monitoring and follow-up.
CONDITIONS
Brief Title
How Early Mobilization Impacts on Diaphragm Thickness in Critically Ill Children
Who Can Participate
Age: 6Months - 12Years
All Genders
Eligibility Criteria
You may qualify if you...
- Children aged more than 6 months and less than 12 years
- Children intubated and mechanically ventilated for less than 24 hours at screening
- Glasgow Coma Scale (GCS) greater than 3 on admission to Pediatric Intensive Care Unit (PICU)
You will not qualify if you...
- History of cardiopulmonary arrest
- History of diaphragmatic paralysis or neuromuscular disease
- Use of neuromuscular blockade
- Expected to be liberated from ventilator in less than 24 hours
- History of mechanical ventilation in the last 6 months
- Presence of tracheostomy
- High cervical spine injury
- Status convulsion
- Thoracic trauma preventing ultrasound examination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - Up to 24 hours from intubation
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 7 days from intubation
Participants are randomized to receive either early mobilization involving individualized rehabilitation activities performed twice daily on weekdays or routine care including standard clinical management without additional early rehabilitation.
Ultrasound measurements on days 1, 3, 5, and 7
Follow-up
Duration - About 10 to 20 days from admission
Participants are monitored for mechanical ventilation duration and length of stay in the Pediatric Intensive Care Unit following treatment.
Visits occur as part of routine ICU care
Trial Site Locations
Total: 1 location
1
Children's Hospital, Fudan University
Shanghai, China
Actively Recruiting
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Research Team
S
Sujuan Wang
Y
Yelin Yao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Diaphragm muscle thinning in patients who are mechanically ventilated.
Horiana B Grosu, Young Im Lee, Jarone Lee...
https://pubmed.ncbi.nlm.nih.gov/23364680Beyond Ventilator-induced Diaphragm Dysfunction: New Evidence for Critical Illness-associated Diaphragm Weakness.
Martin Dres, Alexandre Demoule
https://pubmed.ncbi.nlm.nih.gov/31206375Diaphragm weakness in mechanically ventilated critically ill patients.
Gerald S Supinski, Leigh Ann Callahan
https://pubmed.ncbi.nlm.nih.gov/23786764Muscle atrophy in mechanically-ventilated critically ill children.
Ryan W Johnson, Kay W P Ng, Alexander R Dietz...
https://pubmed.ncbi.nlm.nih.gov/30566470Critical illness-associated diaphragm weakness.
Martin Dres, Ewan C Goligher, Leo M A Heunks...
https://pubmed.ncbi.nlm.nih.gov/28917004Diaphragmatic motion studied by m-mode ultrasonography: methods, reproducibility, and normal values.
Alain Boussuges, Yoann Gole, Philippe Blanc
https://pubmed.ncbi.nlm.nih.gov/19017880Sonographic Evaluation of Diaphragmatic Excursion and Thickness in Healthy Infants and Children.
Hanan El-Halaby, Hesham Abdel-Hady, Gehan Alsawah...
https://pubmed.ncbi.nlm.nih.gov/26679203Mechanical Ventilation-induced Diaphragm Atrophy Strongly Impacts Clinical Outcomes.
Ewan C Goligher, Martin Dres, Eddy Fan...
https://pubmed.ncbi.nlm.nih.gov/28930478Inspiratory muscle training to enhance recovery from mechanical ventilation: a randomised trial.
Bernie M Bissett, I Anne Leditschke, Teresa Neeman...
https://pubmed.ncbi.nlm.nih.gov/27257003