Mechanical VentilationWOBNCT07796321
Effort of Breathing and Dyssynchrony Burden During Assisted Ventilation in Paediatric Patients
A study testing Pressure Support Mode in people with Mechanical Ventilation and Paediatric Intensive Care, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Mechanical Ventilation, Paediatric Intensive Care, Paediatric Dysfunctional Breathing
- What is being tested?
- Pressure Support Mode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 21 Sep 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
- 2 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
The Hospital for Sick Children (SickKids)
Toronto, Ontario, M5G 1E8
Katherine Reise, RT, 416-813-6486, katherine.reise@sickkids.ca
About this study
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
Read the detailed description
Single centre, randomized crossover physiological study to assess effort of breathing and dyssynchrony burden associated with different modes of assisted ventilation in children. We hypothesize that patients on optimized pressure support ventilation (PSV) will 1) not have higher effort of breathing and 2) have a reduced rate of dyssynchronous effort compared to pressure control ventilation (PCV) or synchronized intermittent mandatory ventilation pressure control/pressure support (SIMV PC/PS) that is the current standard of care.
An esophageal catheter will be inserted and calibrated for measuring esophageal pressure (Pes) swings to quantify breathing effort and diagnose dyssynchronies. During passive breathing, the chest wall compliance will be measured. 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) followed by exposure to two modes of assisted ventilation (PCV or PSV) in a randomized crossover manner for 30 min each. Level of support (the pressure above the PEEP) and sedation will remain stable within each participant. PSV optimization: If the PS breath is too short (< 0.2 sec), the inspiratory rise time will be increased to 0.15 sec and the cycling % reduced to 20, 15 or 10% to ensure an adequate size breath (approx 1/3 of the patient's respiratory cycle).
- Being tested
- Pressure Control Mode, Pressure Support Mode
- Keywords
- Mechanical ventilation, Paediatrics, Synchronized intermittent mandatory ventilation (SIMV), Pressure control ventilation (PCV), Pressure support ventilation (PSV), Dyssynchrony
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure Control ModeDevice
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.
Pressure Support ModeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| PCV followed by PSV | Experimental | SIMV PC/PS (30 mins) followed by PCV (30 mins) followed by PSV (30 mins) Receives: 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) Receives: Device: Pressure Control Mode; Device: Pressure Support Mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Comfort quantified by RASS sedation and comfort scale. Dyssynchrony events will be summarized as the proportion of breath with any dyssynchrony per patient and period. To account for baseline variability, comparisons between PCV and PSV will be adjusted for each patient's SIMV baseline dyssynchrony. Similar to Pmus analyses, median, interquartile ranges and p-values from a Wilcoxon signed-rank test will be reported.
Measured: Approximately 90 minutes (30 minutes per mode of mechanical ventilation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start21 Sep 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luciana Rodriguez Guerineau, The Hospital for Sick Children
- Investigators
- Luciana Rodriguez Guerineau, M.D., Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796321
- Sponsor's protocol ID
- 3661
- Acronym
- WOB
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40736370Brochard 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.
PubMed 7921460Esteban 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.
PubMed 7823995Blokpoel 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.
PubMed 34054119Blokpoel 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.
PubMed 26914624Blokpoel 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.
PubMed 33172465
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effort of Breathing and Dyssynchrony Burden During Assisted Ventilation in Paediatric Patients
- ClinicalTrials.gov ID
- NCT07796321
- Acronym / sponsor ID
- WOB / 3661
- Keywords
- Mechanical ventilation, Paediatrics, Synchronized intermittent mandatory ventilation (SIMV), Pressure control ventilation (PCV), Pressure support ventilation (PSV), Dyssynchrony
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 21 Sep 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Single centre, randomized crossover physiological study to assess effort of breathing and dyssynchrony burden associated with different modes of assisted ventilation in children. We hypothesize that patients on optimized pressure support ventilation (PSV) will 1) not have higher effort of breathing and 2) have a reduced rate of dyssynchronous effort compared to pressure control ventilation (PCV) or synchronized intermittent mandatory ventilation pressure control/pressure support (SIMV PC/PS) that is the current standard of care.
An esophageal catheter will be inserted and calibrated for measuring esophageal pressure (Pes) swings to quantify breathing effort and diagnose dyssynchronies. During passive breathing, the chest wall compliance will be measured. 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) followed by exposure to two modes of assisted ventilation (PCV or PSV) in a randomized crossover manner for 30 min each. Level of support (the pressure above the PEEP) and sedation will remain stable within each participant. PSV optimization: If the PS breath is too short (< 0.2 sec), the inspiratory rise time will be increased to 0.15 sec and the cycling % reduced to 20, 15 or 10% to ensure an adequate size breath (approx 1/3 of the patient's respiratory cycle).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PCV followed by PSV | Experimental | Device: Pressure Control Mode, Device: Pressure Support ModeSIMV PC/PS (30 mins) followed by PCV (30 mins) followed by PSV (30 mins) |
| PSV followed by PCV | Experimental | Device: Pressure Control Mode, Device: Pressure Support ModeSIMV PC/PS (30 mins) followed by PSV (30 mins) followed by PCV (30 mins) |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure Control ModeIn 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. | Device | PCV followed by PSV, PSV followed by PCV |
| Pressure Support ModeIn 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. | Device | PCV followed by PSV, PSV followed by PCV |
Primary outcome
Average effort of breathing
Time frame: Analyses will be performed on patient-level summaries averaged over the last 25 minutes of each ventilation mode (SIMV, PCV, PSV).
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.
1 secondary outcome
Dyssynchrony rate quantified by specific software (FluxReview)
Time frame: Approximately 90 minutes (30 minutes per mode of mechanical ventilation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Background: PubMed 40736370Rodriguez 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.
- Background: PubMed 7921460Brochard 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.
- Background: PubMed 7823995Esteban 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.
- Background: PubMed 34054119Blokpoel 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.
- Background: PubMed 26914624Blokpoel 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.
- Background: PubMed 33172465Blokpoel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luciana Rodriguez Guerineau, M.D. principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure Support Mode in people with Mechanical Ventilation and Paediatric Intensive Care, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luciana Rodriguez Guerineau, M.D. (416-813-6486, luciana.rodriguezguerineau@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average effort of breathing (time frame: Analyses will be performed on patient-level summaries averaged over the last 25 minutes of each ventilation mode (SIMV, PCV, PSV).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07796321, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.