How Early Mobilization Impacts on Diaphragm Thickness in Critically Ill Children

NCT04534296 | Recruiting

• 1 other identifier: WangSJ001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mechanical Ventilation Complication; Ventilator-induced Diaphragm Dysfunction

Outcome Measures

Primary Outcomes (1)

• the percentile of cases with increased diaphragm thickness

  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 Outcomes (4)

• the diaphragm thickness

  from intubation up to 7 days

• diaphragmatic thickening fraction (DTF)

  from intubation up to 7 days

• mechanical ventilation time

  from intubation to the day when children are successfully weaned (about 10 days )

• PICU length of stay

  days from admission to discharge from PICU (about 20 days)

Study Arms (2)

Early Mobilization Group (EM group)

EXPERIMENTAL

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

Routine Care Group (RC group)

ACTIVE COMPARATOR

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

Interventions

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.

Early Mobilization Group (EM group)

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.

Routine Care Group (RC group)

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital, Fudan University

Shanghai, China

RECRUITING

Related Publications (11)

• Hudson MB, Smuder AJ, Nelson WB, Bruells CS, Levine S, Powers SK. Both high level pressure support ventilation and controlled mechanical ventilation induce diaphragm dysfunction and atrophy. Crit Care Med. 2012 Apr;40(4):1254-60. doi: 10.1097/CCM.0b013e31823c8cc9.

  PMID: 22425820 BACKGROUND

• Grosu HB, Lee YI, Lee J, Eden E, Eikermann M, Rose KM. Diaphragm muscle thinning in patients who are mechanically ventilated. Chest. 2012 Dec;142(6):1455-1460. doi: 10.1378/chest.11-1638.

  PMID: 23364680 BACKGROUND

• Dres M, Demoule A. Beyond Ventilator-induced Diaphragm Dysfunction: New Evidence for Critical Illness-associated Diaphragm Weakness. Anesthesiology. 2019 Sep;131(3):462-463. doi: 10.1097/ALN.0000000000002825. No abstract available.

  PMID: 31206375 BACKGROUND

• Supinski GS, Callahan LA. Diaphragm weakness in mechanically ventilated critically ill patients. Crit Care. 2013 Jun 20;17(3):R120. doi: 10.1186/cc12792.

  PMID: 23786764 BACKGROUND

• Johnson RW, Ng KWP, Dietz AR, Hartman ME, Baty JD, Hasan N, Zaidman CM, Shoykhet M. Muscle atrophy in mechanically-ventilated critically ill children. PLoS One. 2018 Dec 19;13(12):e0207720. doi: 10.1371/journal.pone.0207720. eCollection 2018.

  PMID: 30566470 BACKGROUND

• Dres M, Goligher EC, Heunks LMA, Brochard LJ. Critical illness-associated diaphragm weakness. Intensive Care Med. 2017 Oct;43(10):1441-1452. doi: 10.1007/s00134-017-4928-4. Epub 2017 Sep 15.

  PMID: 28917004 BACKGROUND

• Boussuges A, Gole Y, Blanc P. Diaphragmatic motion studied by m-mode ultrasonography: methods, reproducibility, and normal values. Chest. 2009 Feb;135(2):391-400. doi: 10.1378/chest.08-1541. Epub 2008 Nov 18.

  PMID: 19017880 BACKGROUND

• El-Halaby H, Abdel-Hady H, Alsawah G, Abdelrahman A, El-Tahan H. Sonographic Evaluation of Diaphragmatic Excursion and Thickness in Healthy Infants and Children. J Ultrasound Med. 2016 Jan;35(1):167-75. doi: 10.7863/ultra.15.01082. Epub 2015 Dec 17.

  PMID: 26679203 BACKGROUND

• Goligher EC, Dres M, Fan E, Rubenfeld GD, Scales DC, Herridge MS, Vorona S, Sklar MC, Rittayamai N, Lanys A, Murray A, Brace D, Urrea C, Reid WD, Tomlinson G, Slutsky AS, Kavanagh BP, Brochard LJ, Ferguson ND. Mechanical Ventilation-induced Diaphragm Atrophy Strongly Impacts Clinical Outcomes. Am J Respir Crit Care Med. 2018 Jan 15;197(2):204-213. doi: 10.1164/rccm.201703-0536OC.

  PMID: 28930478 BACKGROUND

• Bissett BM, Leditschke IA, Neeman T, Boots R, Paratz J. Inspiratory muscle training to enhance recovery from mechanical ventilation: a randomised trial. Thorax. 2016 Sep;71(9):812-9. doi: 10.1136/thoraxjnl-2016-208279. Epub 2016 Jun 2.

  PMID: 27257003 BACKGROUND

• Vivier E, Roussey A, Doroszewski F, Rosselli S, Pommier C, Carteaux G, Mekontso Dessap A. Atrophy of Diaphragm and Pectoral Muscles in Critically Ill Patients. Anesthesiology. 2019 Sep;131(3):569-579. doi: 10.1097/ALN.0000000000002737.

  PMID: 31094757 BACKGROUND

MeSH Terms

Interventions

Early Ambulation

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Liyuan Han

  Children's Hospital of Fudan University

  STUDY DIRECTOR

Central Study Contacts

Sujuan Wang

CONTACT

86-13761000512; sujuanw@163.com

Yelin Yao

CONTACT

yelinyao@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcomes assessor and statistical analyst will be masked to randomization results
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 1, 2020
• Study Start: April 26, 2021
• Primary Completion: April 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

CN (1)