Mechanical Ventilation ComplicationVentilONCT06826794
VentilO Prospective Study
A study testing Clinicians and VenitlO in people with Mechanical Ventilation Complication and Respiratory Acidosis, run by Laval University at 1 site in Canada.
Trial summary
This is a randomized, open-label study comparing intial settings made by clinicians with settings recommandation made by the VentilO application immediately after intensive care unit admission.The study will allow direct comparison of the frequency of acidosis when patients are ventilated using the parameters of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication, Respiratory Acidosis
- What is being tested?
- Clinicians and VenitlO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteCanada
- Study dates
- 24 Apr 2025to Jun 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (> 18 years old)
- Intubated patients admitted to intensive care immediately post-operatively after cardiac surgery (all cardiac surgery combined)
- Ventilation in controlled mode (Assist Control or SIMV)
Who cannot join
- Absence of anthropometric data (height and weight) of patients available in the patient file
- Respiratory cycles mainly spontaneous on arrival
- Patient extubated on arrival in intensive care
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Francois Lellouche Principal investigator, MD, PhD contact
Canada1 site, 1 recruiting
- Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Quebec, G1V4G5
Francois Lellouche, 418-656-8711, francois.lellouche@criucpq.ulaval.ca
Francois Lellouche
About this study
Official title: Frequency of Respiratory Acidosis in the Intensive Care Unit After Postoperative Cardiac Surgery. Impact of Using VentilO Application
This is a randomized, open-label study comparing intial settings made by clinicians with settings recommandation made by the VentilO application immediately after intensive care unit admission.The study will allow direct comparison of the frequency of acidosis when patients are ventilated using the parameters of the VentilO application versus parameters chosen by the clinician. The variables determined by the clinician or VentilO will be respiratory rate, tidal volume and resulting minute ventilation.
- Being tested
- Clinicians, VenitlO
- Medical subject headings
- Acidosis, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CliniciansOther
Clinicians will determine respiratory parameters for mechanical ventilation upon arrival in the intensive care unit.
VenitlODevice
VentilO application (or web platerform) will determine respiratory parameters for mechanical ventilation upon arrival in the intensive care unit.
| Study group | Role | What they receive |
|---|---|---|
| Clinicians | Other | Clinicians include respiratory therapists, physcians, medical students Receives: Other: Clinicians |
| VentilO | Active comparator | VentilO, smartphone application (or web plateform) Receives: Device: VenitlO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory acidosis
The frequency of respiratory acidosis on arterial gas after 20 minutes of mechanical ventilation (pH < 7.35 and PaCO2 > 45mmHg)
Measured: 20 minutes after initiation of mechanical ventilation
Secondary outcomes (1)
Acid-base disorders on arrival in intensive care
The frequency and severity of acid-base disorders on arrival in intensive care (pH<7.35 or pH > 7.45)
Measured: 5 minutes after initiation 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 posted14 Feb 2025
- Study start24 Apr 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, François Lellouche, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826794
- Sponsor's protocol ID
- 2025-4300
- Acronym
- VentilO
- Status last verified
- Aug 2025
- First submitted
- 28 Jan 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roch R, Bouchard PA, Couture E, Lellouche F. Patient-Centered Ventilator Settings to Reduce Respiratory Acidosis After Cardiac Surgery. Respir Care. 2026 Apr;71(4):366-374. doi: 10.1177/19433654251412340. Epub 2026 Feb 19.
PubMed 41711585
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Respiratory Acidosis in the Intensive Care Unit After Postoperative Cardiac Surgery. Impact of Using VentilO Application
- ClinicalTrials.gov ID
- NCT06826794
- Acronym / sponsor ID
- VentilO / 2025-4300
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 24 Apr 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 14 Feb 2025 (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.
This is a randomized, open-label study comparing intial settings made by clinicians with settings recommandation made by the VentilO application immediately after intensive care unit admission.The study will allow direct comparison of the frequency of acidosis when patients are ventilated using the parameters of the VentilO application versus parameters chosen by the clinician. The variables determined by the clinician or VentilO will be respiratory rate, tidal volume and resulting minute ventilation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinicians | Other | Other: CliniciansClinicians include respiratory therapists, physcians, medical students |
| VentilO | Active comparator | Device: VenitlOVentilO, smartphone application (or web plateform) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (> 18 years old)
- Intubated patients admitted to intensive care immediately post-operatively after cardiac surgery (all cardiac surgery combined)
- Ventilation in controlled mode (Assist Control or SIMV)
Key exclusion criteria (3 listed)
- Absence of anthropometric data (height and weight) of patients available in the patient file
- Respiratory cycles mainly spontaneous on arrival
- Patient extubated on arrival in intensive care
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 |
|---|---|---|
| CliniciansClinicians will determine respiratory parameters for mechanical ventilation upon arrival in the intensive care unit. | Other | Clinicians |
| VenitlOVentilO application (or web platerform) will determine respiratory parameters for mechanical ventilation upon arrival in the intensive care unit. | Device | VentilO |
Primary outcome
Respiratory acidosis
Time frame: 20 minutes after initiation of mechanical ventilation
The frequency of respiratory acidosis on arterial gas after 20 minutes of mechanical ventilation (pH < 7.35 and PaCO2 > 45mmHg)
1 secondary outcome
Acid-base disorders on arrival in intensive care
Time frame: 5 minutes after initiation 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 4 Sep 2025.
- Derived from this study: PubMed 41711585Roch R, Bouchard PA, Couture E, Lellouche F. Patient-Centered Ventilator Settings to Reduce Respiratory Acidosis After Cardiac Surgery. Respir Care. 2026 Apr;71(4):366-374. doi: 10.1177/19433654251412340. Epub 2026 Feb 19.
- 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.
Francois Lellouche Principal investigator, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinicians and VenitlO in people with Mechanical Ventilation Complication and Respiratory Acidosis, run by Laval University 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 3 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: looking for participants now, as of the sponsor's last update on 4 Sep 2025. 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 Francois Lellouche Principal investigator, MD, PhD (1-418-656-8711 ext. 3572, francois.lellouche@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory acidosis (time frame: 20 minutes after initiation of mechanical ventilation). 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 NCT06826794, which also lists 1 linked publication.
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 4 Sep 2025.