NCT05459116

Brief Summary

This is a multicentre prospective cohort trial in adult and pediatric ICU patients. The investigators will measure the effect of a patient's inspiratory effort during mechanical ventilation on the lungs and diaphragm. The investigators will daily (for a maximum of 8 days) measure esophageal pressures with a balloon catheter to quantify inspiratory effort and respiratory muscle function, and perform daily ultrasound measurements of the diaphragm and the lungs. The investigators hypothesize that a small inspiratory effort will result in the preservation of diaphragm function and have no adverse effect on lung function.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
2 countries

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 21, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 6, 2025

Status Verified

September 1, 2024

Enrollment Period

2.8 years

First QC Date

June 28, 2022

Last Update Submit

April 3, 2025

Conditions

Respiratory MusclesRespiration, ArtificialRespiratory Function Tests

Outcome Measures

Primary Outcomes (8)

  • Tidal esophageal pressure swing (∆Pes) - D1

    Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.

    ∆Pes (average over 1 minute recording) at day 1 of mechanical ventilation

  • Tidal esophageal pressure swing (∆Pes) - D2

    Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.

    ∆Pes (average over 1 minute recording) at day 2 of mechanical ventilation

  • Tidal esophageal pressure swing (∆Pes) - D3

    Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.

    ∆Pes (average over 1 minute recording) at day 3 of mechanical ventilation

  • Tidal esophageal pressure swing (∆Pes) - D4

    Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.

    ∆Pes (average over 1 minute recording) at day 4 of mechanical ventilation

  • Tidal esophageal pressure swing (∆Pes) - D5

    Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.

    ∆Pes (average over 1 minute recording) at day 5 of mechanical ventilation

  • Tidal esophageal pressure swing (∆Pes) - D6

    Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.

    ∆Pes (average over 1 minute recording) at day 6 of mechanical ventilation

  • Tidal esophageal pressure swing (∆Pes) - D7

    Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.

    ∆Pes (average over 1 minute recording) at day 7 of mechanical ventilation

  • Tidal esophageal pressure swing (∆Pes) - D8

    Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.

    ∆Pes (average over 1 minute recording) at day 8 of mechanical ventilation

Secondary Outcomes (90)

  • Transpulmonary driving pressure (ΔPL) - D1

    ∆PL (average over 1 minute recording) at day 1 of mechanical ventilation

  • Transpulmonary driving pressure (ΔPL) - D2

    ∆PL (average over 1 minute recording) at day 2 of mechanical ventilation

  • Transpulmonary driving pressure (ΔPL) - D3

    ∆PL (average over 1 minute recording) at day 3 of mechanical ventilation

  • Transpulmonary driving pressure (ΔPL) - D4

    ∆PL (average over 1 minute recording) at day 4 of mechanical ventilation

  • Transpulmonary driving pressure (ΔPL) - D5

    ∆PL (average over 1 minute recording) at day 5 of mechanical ventilation

  • +85 more secondary outcomes

Study Arms (1)

Overall group

EXPERIMENTAL

Placement of a nasogastric balloon

Device: Placement of nasogastric balloon

Interventions

Placement of nasogastric balloonDEVICE

A nasogastric balloon catheter will be inserted after inclusion. This will be a NutriVent (Sidam S.R.L., Mirandola, Italy) for patients \>40kg, and a SmartCath Esophageal pressure catheter (Vyaire/Carefusion) for patients \<40kg. This placement is similar to a standard nasogastric tube placement, which is a common procedure in an ICU. Potential minor side effects include a nosebleed, sore throat and erosion of the nose where the tube is anchored. All patients will receive this intervention. When the esophageal catheter becomes displaced or is accidentally removed during the study period, it will be replaced.

Overall group

Eligibility Criteria

Age29 Days+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 28 days
  • weight \> 3kg
  • requiring invasive mechanical ventilation
  • anticipated length of ventilation \> 48h

You may not qualify if:

  • refusal of consent
  • known anatomical malformation of the diaphragm (including congenital diaphragmatic hernia)
  • contra-indication to the placement of a naso-gastric esophageal balloon catheter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Antwerp University Hospital (UZA)

Edegem, Antwerp, 2650, Belgium

RECRUITING

University Hospital Leuven (UZL)

Leuven, 3000, Belgium

RECRUITING

The Hospital for Sick Children (SickKids)

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tom Schepens, M.D., Ph.D.

    PICU staff member

    STUDY DIRECTOR

Central Study Contacts

Vertongen

CONTACT

+323 821 44 04icu-research@uza.be

Marquez

CONTACT

+323 821 36 35inzo@uza.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2022

First Posted

July 14, 2022

Study Start

September 21, 2022

Primary Completion

June 30, 2025

Study Completion

December 1, 2025

Last Updated

April 6, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)BE(2)