Pediatric Diaphragm Thickness Trial

NCT04882553 | Completed

• 2 other identifiers: 21/15/2081653
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The evaluation of diaphragm function in ventilated patients is not easy. One option is to use esophageal pressure (Pes) measurements but recently, diaphragmatic ultrasound has proven itself as a useful tool in this setting. In adults the thickening fraction (TF), which describes the difference in thickness between end-inspiration and end-expiration, correlates with the diaphragmatic pressure-time product per breath (PTPdi), an esophageal pressure-derived work of breathing parameter. There is a lack of data that tells us whether the same is true in children. This physiological study intends to look at the correlation between esophageal pressures and thickening fraction assessed by ultrasound in a pediatric cohort of patients.

Conditions

Child

Keywords

diaphragm thickening fraction; oesophageal pressure

Outcome Measures

Primary Outcomes (3)

• Esophageal pressure (cmH2O) at increasing levels of respiratory effort in spontaneously breathing, sedated children.

  Esophageal pressures are measured in the lower third of the esophagus using an esophageal balloon and registered by an external pressure transducer.

  Perioperatively

• Diaphragmatic thickening fraction (%) at increasing levels of respiratory effort in spontaneously breathing, sedated children.

  The diaphragmatic thickening fraction (%) is calculated as \[thickness at end-inspiration (mm) - thickness at end-expiration (mm)\] / thickness at end-expiration (mm) x 100%. Diaphragmatic thickness is measured by ultrasound.

  Perioperatively

• Feasibility (% success) of measuring diaphragmatic thickening fraction in spontaneously breathing ventilated children

  The rate of success of diaphragmatic ultrasound in children, calculated as count of successful measurements / \[count of successful measurements + count of unsuccessful measurements\] x 100%

  Perioperatively

Secondary Outcomes (1)

• Diaphragm thickness (mm) at different levels of positive end-expiratory pressure in spontaneously breathing, sedated children.

  Perioperatively

Study Arms (1)

Incremental inspiratory effort

EXPERIMENTAL

Every participant will be subjected to a stepwise incremental inspiratory effort: 1. Ventilated 2. Baseline spontaneous breathing with deep anesthesia (minimal alveolar concentration 1.5) 3. Spontaneous breathing with PEEP 10 and deep anesthesia (minimal alveolar concentration 1.5) 4. Spontaneous breathing with PEEP 0 and deep anesthesia (minimal alveolar concentration 1.5) 5. Spontaneous breathing with PEEP 0 and moderate anesthesia (minimal alveolar concentration 1.0) 6. Spontaneous breathing with PEEP 0 and moderate anesthesia (minimal alveolar concentration 1.0) and added inspiratory threshold of +7cmH2O 7. Spontaneous breathing with PEEP 0 and moderate anesthesia (minimal alveolar concentration 1.0) and added inspiratory threshold of +15cmH2O

Procedure: Diaphragmatic echography; Procedure: Measurement of esophageal pressure; Diagnostic Test: Registration of respiratory mechanics

Interventions

Diaphragmatic echography PROCEDURE

Echography of the diaphragm at the zone of apposition. End-inspiratory and/or end-expiratory thickness of the diaphragm will be measured in M-mode.

Incremental inspiratory effort

Measurement of esophageal pressure PROCEDURE

Pressure will be measured in the lower third of the esophagus using an esophageal balloon and pressure transducer.

Incremental inspiratory effort

Registration of respiratory mechanics DIAGNOSTIC_TEST

Pressures and volumes will be registered by the Fluxmed respiratory monitor (MBMED, Argentina)

Incremental inspiratory effort

Eligibility Criteria

• Age: 28 Days - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The patient must require general anaesthesia

You may not qualify if:

• The patient is mechanically ventilated before start of the study.
• The patient is not anticipated to breathe spontaneously for a substantial amount of time prior to emergence from anesthesia
• The patient is known or suspected to have an anatomical malformation or surgical correction of the diaphragm.
• The patient suffers from a disease that may impair diaphragmatic function:
• Central neural disease at the level of the brain (Stroke, Arnold-Chiari malformation) and spinal cord (quadriplegia, spinal muscular atrophy, syringomyelia).
• Neural disease of the phrenic nerve (Guillain-Barré syndrome, tumor compression).
• Disorders of the neuromuscular junction.
• Muscular diseases (muscular dystrophies, myositis (infectious, inflammatory, metabolic).

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

Related Publications (1)

• De Meyer GR, Flamey L, Adriaensens I, Van der Aerschot M, Van de Walle H, Vanmarsenille I, Jorens PG, Goligher EC, Saldien V, Schepens T. The Relationship Between Esophageal Pressure and Diaphragm Thickening Fraction in Spontaneously Breathing Sedated Children: A Feasibility Study. Pediatr Crit Care Med. 2023 Aug 1;24(8):652-661. doi: 10.1097/PCC.0000000000003248. Epub 2023 Apr 24.

  PMID: 37092829 DERIVED

Study Officials

• Tom Schepens, MD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: data manager

Model Details: a single-centre physiological cohort study to evaluate the feasibility of using the thickening fraction as a parameter for diaphragm activity during spontaneous breathing in sedated children.

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 12, 2021
• Study Start: June 11, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: January 24, 2022

Record last verified: 2021-09

Locations

BE (1)