Effort of Breathing and Dyssynchrony Burden During Assisted Ventilation in Paediatric Patients

NCT07796321 | Not Yet Recruiting

• 1 other identifier: 3661
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this trial is to learn if one mode of mechanical ventilation (i.e. machine to help with breathing) is better than another in children who need help from a machine to breathe. The main questions it aims to answer are:

• How hard do children need to work to breathe when they are using different types of modes of mechanical ventilation?
• Evaluate which mode of mechanical ventilation performs better when the patient is clinically awake enough to start breaths

Conditions

Mechanical Ventilation; Paediatric Intensive Care; Paediatric Dysfunctional Breathing

Keywords

Mechanical ventilation; Paediatrics; Synchronized intermittent mandatory ventilation (SIMV); Pressure control ventilation (PCV); Pressure support ventilation (PSV); Dyssynchrony

Outcome Measures

Primary Outcomes (1)

• Average effort of breathing

  Muscular pressure or Pmus (calculated from DPes and using the chest wall compliance of the participant and measured by specific software \[FluxReview\]) during the assisted modes. For each patient, the change in Pmus from SIMV to PSV and from SIMV to PCV will be computed. The within-patient difference between these changes will be summarized in terms of median and interquartile range, and assessed using a Wilcoxon signed-rank test.

  Analyses will be performed on patient-level summaries averaged over the last 25 minutes of each ventilation mode (SIMV, PCV, PSV).

Secondary Outcomes (1)

• Dyssynchrony rate quantified by specific software (FluxReview)

  Approximately 90 minutes (30 minutes per mode of mechanical ventilation)

Study Arms (2)

PCV followed by PSV

EXPERIMENTAL

SIMV PC/PS (30 mins) followed by PCV (30 mins) followed by PSV (30 mins)

Device: Pressure Control Mode; Device: Pressure Support Mode

PSV followed by PCV

EXPERIMENTAL

SIMV PC/PS (30 mins) followed by PSV (30 mins) followed by PCV (30 mins)

Device: Pressure Control Mode; Device: Pressure Support Mode

Interventions

Pressure Control Mode DEVICE

In pressure control mode every breath is controlled by the ventilator, including when the breaths are delivered. This mode is typically used when patients are sedated and unable to breathe on their own.

PCV followed by PSV; PSV followed by PCV

Pressure Support Mode DEVICE

In pressure support mode every breath is initiated and controlled by the patient. This mode is used when patients are awake enough to take all breaths on their own.

PCV followed by PSV; PSV followed by PCV

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Consent provided
• Aged: birth to 18 years of age
• Invasively mechanically ventilated and expected to remain intubated for ≥ 6 hours, in the ventilator weaning phase.

You may not qualify if:

• Contraindication for esophageal catheter placement such as esophageal repair (e.g. esophageal surgery or esophageal varices)
• On Extracorporeal Membrane Oxygenation (ECMO)
• Undergoing assessment for brain death or brain death confirmed
• Patients with a severe systemic disease that poses a constant threat to their life:
• \<24 hrs post cardiac arrest
• or more inotropes increasing by \>20% within the last 24 hrs
• increase in ventilation support or an FiO2 change ≥30% within the last 24 hrs
• most responsible physician (MRP) determine patient is not eligible for the study intervention

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children (SickKids)

Toronto, Ontario, M5G 1E8, Canada

Location

Related Publications (6)

• Rodriguez Guerineau L, Nonoyama M, Masy V, Ferreyro BL, Floh A, Brochard L. Evolution of Mechanical Ventilation Practices in Neonatal Cardiac Patients: Single-Center Retrospective Analysis of Three 1-Year Epochs During 2000-2020. Pediatr Crit Care Med. 2025 Sep 1;26(9):e1154-e1164. doi: 10.1097/PCC.0000000000003799. Epub 2025 Jul 30.

  PMID: 40736370 BACKGROUND

• Brochard L, Rauss A, Benito S, Conti G, Mancebo J, Rekik N, Gasparetto A, Lemaire F. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med. 1994 Oct;150(4):896-903. doi: 10.1164/ajrccm.150.4.7921460.

  PMID: 7921460 BACKGROUND

• Esteban A, Frutos F, Tobin MJ, Alia I, Solsona JF, Valverdu I, Fernandez R, de la Cal MA, Benito S, Tomas R, et al. A comparison of four methods of weaning patients from mechanical ventilation. Spanish Lung Failure Collaborative Group. N Engl J Med. 1995 Feb 9;332(6):345-50. doi: 10.1056/NEJM199502093320601.

  PMID: 7823995 BACKGROUND

• Blokpoel RGT, Burgerhof JGM, Markhorst DG, Kneyber MCJ. Trends in Pediatric Patient-Ventilator Asynchrony During Invasive Mechanical Ventilation. Pediatr Crit Care Med. 2021 Nov 1;22(11):993-997. doi: 10.1097/PCC.0000000000002788.

  PMID: 34054119 BACKGROUND

• Blokpoel RG, Burgerhof JG, Markhorst DG, Kneyber MC. Patient-Ventilator Asynchrony During Assisted Ventilation in Children. Pediatr Crit Care Med. 2016 May;17(5):e204-11. doi: 10.1097/PCC.0000000000000669.

  PMID: 26914624 BACKGROUND

• Blokpoel RGT, Koopman AA, van Dijk J, Kneyber MCJ. Additional work of breathing from trigger errors in mechanically ventilated children. Respir Res. 2020 Nov 10;21(1):296. doi: 10.1186/s12931-020-01561-3.

  PMID: 33172465 BACKGROUND

Study Officials

• Luciana Rodriguez Guerineau, M.D.

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciana Rodriguez Guerineau, M.D.

CONTACT

416-813-6486; luciana.rodriguezguerineau@sickkids.ca

Cynthia de Medeiros, M.Sc.

CONTACT

416-813-7654; cynthia.demedeiros@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Model Details: An esophageal catheter will be inserted and calibrated for measuring esophageal pressure (Pes) swings. When the patients are in the ventilation weaning phase and triggering consistently in SIMV mode, a 30 min recording of respiratory signals will be performed (clinical mode, standard of care) followed by exposure to two modes of assisted ventilation: Pressure Control Ventilation (PCV) or Pressure Support Ventilation (PSV) in a randomized crossover manner for 30 min each.

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start: September 21, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)