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the PROCEDURES Study

Sponsor
Leiden University Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05965830
Collaborator
(none)
50
Enrollment
14
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Background of the study:

Increased work of breathing, potentially leading to respiratory insufficiency, resulting in the need of (non-) invasive respiratory support is the most common observed problem in the neonatal - and pediatric intensive care unit (NICU/PICU). The diaphragm is the main respiratory muscle. Currently there is not an established technique accessible to observe the (clinical) function of the diaphragm and its role in respiratory insufficiency. New non-invasive modalities are promising, such as transcutaneous diaphragm electromyography (dEMG) and diaphragm ultrasound (dUS).

Objective of the study:

Our objective is to assess the association between transcutaneous diaphragm electromyography (dEMG) and diaphragm ultrasound (dUS) in the PICU population.

Study design:

Single center pilot study

Study population:

The study population consists of children between 0-12 months, admitted to the PICU of the Leiden University Medical Center, with invasive respiratory support.

Primary study parameters/outcome of the study:

Primary endpoint is to evaluate the association between dEMG and dUS measurements in the PICU population.

Condition or Disease Intervention/Treatment Phase
  • Device: Diaphragm ultrasound

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
PRospective Observational Study Comparing Electromyography of the Diaphragm With Ultrasound in Neonates and Children With REspiratory Support: the PROCEDURES Study
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Study cohort

The study population consists of clinically stable infants or pediatric patients up to 12 months of age admitted to the PICU.

Device: Diaphragm ultrasound
A single, simultaneous assessment of the diaphragm muscle functioning through dEMG and dUS at the time of spontaneous breathing.
Other Names:
  • transcutaneous diaphragm EMG

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Primary endpoint [1 year]

      to evaluate the association between dEMG and dUS measurements in the PICU population.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Months to 12 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age between 0 - 12 months of age at the moment of inclusion and born ≥ 37 weeks gestational age.

    • Specific patients cohort PICU:

    pediatric patients with invasive respiratory support comply with the extubation readiness test (ERT) criteria

    • No spontaneous breathing for the duration of the assessment

    • Written parenteral informed consent (IC)

    • A patient can only participate once

    Exclusion Criteria:

    • Unilateral diaphragm paresis diagnosed by ultrasound

    • Congenital malformations not compatible with dEMG

    • Need of cardiac pacing

    • Congenital muscle atrophy disorder

    • Clinical instability requiring frequent interventions by the nursing staff that may interfere with the measurements

    • The attending physician considers the patient to be too vulnerable to participate in the study

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Leiden University Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    sgjheisterkamp, MD, Leiden University Medical Center
    ClinicalTrials.gov Identifier:
    NCT05965830
    Other Study ID Numbers:
    • P23-007
    First Posted:
    Jul 28, 2023
    Last Update Posted:
    Jul 28, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 28, 2023