Mechanical Ventilation ComplicationNCT05886413
Potential Impact of the Use of the Application VentilO After Cardiac Surgery
An observational study of Mechanical Ventilation Complication, run by Laval University at 1 site in Canada.
Trial summary
Mechanical ventilation is a vital support associated with the treatment of patients with acute respiratory failure and in other indications such as surgery under general anesthesia, coma or shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication
- What is being tested?
- VentilO application
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 24 Aug 2023to 20 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Adult patients who are admitted to the cardiac intensive care unit of the ICUPQ-UL following cardiac surgery
Who may be able to join
- Adults (> or = 18 years old)
- Intubated patients admitted to the ICU immediately postoperative from cardiac surgery
- Obtained a postoperative arterial gas within 1 hour of arrival in the ICU
Who cannot join
- Lack of patient anthropometric data (height and weight) available in the patient record
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, G1V4G5
About this study
Official title: Frequency of Respiratory Acidosis and Alkalosis in Intensive Care Department of the IUCPQ-UL After Cardiac Surgery. Potential Impact of the Use of the Application VentilO
Mechanical ventilation is a vital support associated with the treatment of patients with acute respiratory failure and in other indications such as surgery under general anesthesia, coma or shock. Optimization of settings during mechanical ventilation and implementation of protective ventilation help to avoid ventilation-induced injury, ensure adequate oxygenation and maintain adequate carbon dioxide concentration to avoid respiratory acidosis or alkalosis.
Similarly, there is also no clear recommendation, to our knowledge, for the initial setting of the respiratory rate. Therefore, initial settings are not always adequate and in the literature the frequency of respiratory acidosis is very high, reaching about half of the patients receiving mechanical ventilation.
Read more
VentilO, is an application that is available on smart phones. This educational application provides clinicians with initial settings and optimization of these settings based on gender, height, weight, body temperature and patient type. The algorithm used is based on published data regarding ventilatory requirements in different populations and the anatomical and instrumental dead space of patients.
The purpose of our study is to:
Assess whether ventilatory settings after intensive care unit admission after cardiac surgery are appropriate to compare the ventilatory adjustments made by clinicians with those proposed by the VentilO application.
- Conditions
- Mechanical Ventilation Complication
- Being tested
- VentilO application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VentilO applicationOther
This educational application provides clinicians with combinations of tidal volume and respiratory rate based on gender, height, weight, body temperature and patient type. The algorithm used is based on published data regarding ventilatory requirements in different populations (i.e. from intubated patients for scheduled surgery to the most severe ICU patients) and anatomical and instrumental dead space.
The objective of this application is to help implement personalized protective ventilation in intubated patients according to their characteristics.
After patient data entry in the VentilO application, the investigators will compare the recommended settings (for mechanical ventilation) vs the real clinician settings done by clinician after patient admission in ICU after cardiac surgery. The investigators will evaluated the potential effect of the VentilO recommendation on the first arterial (or capillary) blood gases compared to the real settings.
| Study group | Role | What they receive |
|---|---|---|
| Intubated patient admitted in intensive care unit at the IUCPQ-UL after cardiac surgery | Not described Receives: Other: VentilO application |
What is being measured
The primary outcome is the main question the study is designed to answer.
acid-base abnormalities on arterial blood gases
Evaluate the frequency of acid-base abnormalities, either acidosis or alkalosis, of respiratory or mixed origin on the first arterial gases after intubation.
Respiratory acidosis is defined as a pH < 7.35 with a PaCO2 > 45 mmHg, and respiratory alkalosis as a pH > 7.45 with a PaCO2 < 35 mmHg)
Measured: On the first result available of arterial blood gases after intensive care unit admission; 1 hour maximum after intensive care admission
Secondary outcomes (8)
Occurence of optimal arterial blood gases result
An optimal arterial blood gases as defined by a pH between 7.35 and 7.45 with a PaCO2 between 36 and 45 mmHg
Measured: On the first result available of arterial blood gases after intensive care unit admission; 1 hour maximum after intensive care admission
Severity of unbalance of arterial blood gases result
For acid-base abnormalities, they will be evaluated according to their level of severity: the frequency of moderate (pH between 7.30 and 7.34) and severe (pH < 7.30) acidoses, and the frequency of moderate (pH between 7.46 and 7.50) and severe (pH > 7.50) alkaloses.
The frequency of moderate (PaCO2 between 46 and 50 mmHg) and severe (PaCO2 > 50 mmHg) hypercapnia, and the frequency of moderate (PaCO2 between 31 and 35 mmHg) and severe (PaCO2 < 31 mmHg) hypocapnia.
Measured: On the first result available of arterial blood gases after intensive care unit admission; 1 hour maximum after intensive care admission
hemodynamic instabilities
Number of arterial hypotension requiring vascular filling > 1000 ml and/or use of vasopressors or inotropes such as levophed or adrenaline at > 0.05 mcg/kg/min)
Measured: Between Hour0 to Hour1 after intensive care unit admission
ICU length of stay
ICU length of stay - ICU admission through ICU discharge
Measured: up to 90 days. ICU stay - ICU admission through ICU discharge or until death if occured
Mechanical Ventilation duration
Time spent with invasive mechanical ventilation during ICU length of stay
Measured: up to 90 days. ICU stay - ICU admission through ICU discharge or until death if occured
Acute renal failure
rate of acute renal failure during ICU length of stay. Renal failure will be defined according to the usual criteria, i.e., an increase of >27 mmol/L creatinine in 48 hours or 1.5x over the preoperative baseline
Measured: up to 90 days. ICU stay - ICU admission through ICU discharge or until death if occured
Hospital length of stay
Hospital length of stay - ICU admission through hospital discharge
Measured: up to 90 days. ICU stay - ICU admission through ICU discharge or until death if occured
ICU mortality
Occurence of death during ICU stay
Measured: up to 90 days. ICU admission through until death if occured
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start24 Aug 2023
- Primary completion16 Oct 2024
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
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
- NCT05886413
- Sponsor's protocol ID
- 2023-4030
- Status last verified
- Aug 2025
- First submitted
- 23 May 2023
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Respiratory Acidosis and Alkalosis in Intensive Care Department of the IUCPQ-UL After Cardiac Surgery. Potential Impact of the Use of the Application VentilO
- ClinicalTrials.gov ID
- NCT05886413
- Acronym / sponsor ID
- 2023-4030
- Conditions
- Mechanical Ventilation Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 2 Jun 2023 (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.
Mechanical ventilation is a vital support associated with the treatment of patients with acute respiratory failure and in other indications such as surgery under general anesthesia, coma or shock. Optimization of settings during mechanical ventilation and implementation of protective ventilation help to avoid ventilation-induced injury, ensure adequate oxygenation and maintain adequate carbon dioxide concentration to avoid respiratory acidosis or alkalosis.
Similarly, there is also no clear recommendation, to our knowledge, for the initial setting of the respiratory rate. Therefore, initial settings are not always adequate and in the literature the frequency of respiratory acidosis is very high, reaching about half of the patients receiving mechanical ventilation.
VentilO, is an application that is available on smart phones. This educational application provides clinicians with initial settings and optimization of these settings based on gender, height, weight, body temperature and patient type. The algorithm used is based on published data regarding ventilatory requirements in different populations and the anatomical and instrumental dead space of patients.
The purpose of our study is to:
Assess whether ventilatory settings after intensive care unit admission after cardiac surgery are appropriate to compare the ventilatory adjustments made by clinicians with those proposed by the VentilO application.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intubated patient admitted in intensive care unit at the IUCPQ-UL after cardiac surgery | – | Other: VentilO application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who are admitted to the cardiac intensive care unit of the ICUPQ-UL following cardiac surgery
Key inclusion criteria (3 listed)
- Adults (> or = 18 years old)
- Intubated patients admitted to the ICU immediately postoperative from cardiac surgery
- Obtained a postoperative arterial gas within 1 hour of arrival in the ICU
Key exclusion criteria (1 listed)
- Lack of patient anthropometric data (height and weight) available in the patient record
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 |
|---|---|---|
| VentilO applicationThis educational application provides clinicians with combinations of tidal volume and respiratory rate based on gender, height, weight, body temperature and patient type. The algorithm used is based on published data regarding ventilatory requirements in different populations (i.e. from intubated patients for scheduled surgery to the most severe ICU patients) and anatomical and instrumental dead space. The objective of this application is to help implement personalized protective ventilation in intubated patients according to their characteristics. After patient data entry in the VentilO application, the investigators will compare the recommended settings (for mechanical ventilation) vs the real clinician settings done by clinician after patient admission in ICU after cardiac surgery. The investigators will evaluated the potential effect of the VentilO recommendation on the first arterial (or capillary) blood gases compared to the real settings. | Other | Intubated patient admitted in intensive care unit at the IUCPQ-UL after cardiac surgery |
Primary outcome
acid-base abnormalities on arterial blood gases
Time frame: On the first result available of arterial blood gases after intensive care unit admission; 1 hour maximum after intensive care admission
Evaluate the frequency of acid-base abnormalities, either acidosis or alkalosis, of respiratory or mixed origin on the first arterial gases after intubation. Respiratory acidosis is defined as a pH < 7.35 with a PaCO2 > 45 mmHg, and respiratory alkalosis as a pH > 7.45 with a PaCO2 < 35 mmHg)
8 secondary outcomes
Occurence of optimal arterial blood gases result
Time frame: On the first result available of arterial blood gases after intensive care unit admission; 1 hour maximum after intensive care admission
Severity of unbalance of arterial blood gases result
Time frame: On the first result available of arterial blood gases after intensive care unit admission; 1 hour maximum after intensive care admission
hemodynamic instabilities
Time frame: Between Hour0 to Hour1 after intensive care unit admission
ICU length of stay
Time frame: up to 90 days. ICU stay - ICU admission through ICU discharge or until death if occured
Mechanical Ventilation duration
Time frame: up to 90 days. ICU stay - ICU admission through ICU discharge or until death if occured
Acute renal failure
Time frame: up to 90 days. ICU stay - ICU admission through ICU discharge or until death if occured
Hospital length of stay
Time frame: up to 90 days. ICU stay - ICU admission through ICU discharge or until death if occured
ICU mortality
Time frame: up to 90 days. ICU admission through until death if occured
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation Complication, 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 1 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: finished, as of the sponsor's last update on 28 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acid-base abnormalities on arterial blood gases (time frame: On the first result available of arterial blood gases after intensive care unit admission; 1 hour maximum after intensive care admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2025.