Recruiting

Respiratory Mechanics

Sponsor:

University Hospital, Antwerp

Code:

NCT05459116

Conditions

Respiratory Muscles

Respiration, Artificial

Respiratory Function Tests

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Placement of nasogastric balloon

Study Details

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.

Conditions

Respiratory Muscles

Respiration, Artificial

Respiratory Function Tests

Study ID

NCT05459116

Start date

Sep 21, 2022

Status verified date

Sep, 2024

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • refusal of consent
  • mechanical ventilation ≤ 2 weeks before inclusion
  • known anatomical malformation of the diaphragm (including congenital diaphragmatic hernia)
  • contra-indication to the placement of a naso-gastric esophageal balloon catheter

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Overall group

Placement of a nasogastric balloon

Interventions

Placement of nasogastric balloon

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.

Primary outcome measure

  • Tidal esophageal pressure swing (∆Pes) - D1 [ Time Frame: ∆Pes (average over 1 minute recording) at day 1 of mechanical ventilation ]
  • Tidal esophageal pressure swing (∆Pes) - D2 [ Time Frame: ∆Pes (average over 1 minute recording) at day 2 of mechanical ventilation ]
  • Tidal esophageal pressure swing (∆Pes) - D3 [ Time Frame: ∆Pes (average over 1 minute recording) at day 3 of mechanical ventilation ]
  • Tidal esophageal pressure swing (∆Pes) - D4 [ Time Frame: ∆Pes (average over 1 minute recording) at day 4 of mechanical ventilation ]
  • Tidal esophageal pressure swing (∆Pes) - D5 [ Time Frame: ∆Pes (average over 1 minute recording) at day 5 of mechanical ventilation ]
  • Tidal esophageal pressure swing (∆Pes) - D6 [ Time Frame: ∆Pes (average over 1 minute recording) at day 6 of mechanical ventilation ]
  • Tidal esophageal pressure swing (∆Pes) - D7 [ Time Frame: ∆Pes (average over 1 minute recording) at day 7 of mechanical ventilation ]
  • Tidal esophageal pressure swing (∆Pes) - D8 [ Time Frame: ∆Pes (average over 1 minute recording) at day 8 of mechanical ventilation ]

Central Contacts and Locations

Central contacts

Vertongen

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

Marquez

+323 821 36 35inzo@uza.be

Locations

The Hospital for Sick Children (SickKids)

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Ta

eva.ta@sickkids.ca

Principal Investigator:

Gail Annich, M.D.

More Information

Sponsor

University Hospital, Antwerp

Last update posted

Apr 6, 2025

Last verified

Sep, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospital, Antwerp on 2025-04-06.