ARDS, HumanVentiloNCT04390360
Smartphone Application for Initiation of Protective Ventilation. Clinical Impact of Instrumental Dead Space Reduction
A study testing Protective ventilation implementation, Protective ventilation with HME and Protective ventilation with Heated humidifier in people with ARDS, Human and Mechanical Ventilation Complication, run by Laval University at 1 site in Canada.
Trial summary
Clinical evaluation of a new educative tools (Smartphone application) based on impact of instrumental dead space reduction after initiation of protective ventilation during mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Human, Mechanical Ventilation Complication, Humidifier Lung
- What is being tested?
- Protective ventilation implementation, Protective ventilation with HME and Protective ventilation with Heated humidifier
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2019to 30 Jun 2024
- Phase
- Interventional
- 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
Who may be able to join
- Age > 18 years old
- Mechanical ventilation (control,assist control or SIMV mode)
- haemodynamic stability (vasopressor < 0.2 ug/kg/min)
- no prone position schedule in the next 2 hours following procedure inclusion
- presence of an Arterial catheter
Who cannot join
- ECMO or anticipate ECMO
- body temperature < 36.0 for post operative patient (cardiac surgery)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, G1V4G5
Pierre-Alexandre Bouchard, 418-656-8711 ext. 2712, pierre-alexandre.bouchard@criucpq.ulaval.ca
Francois Lellouche
About this study
Official title: Development and Evaluation of Smartphone App for Initiation of Protective Ventilation. Clinical Impact of Instrumental Dead Space Reduction on Physiologic Parameter Based on the Smartphone App
Clinical evaluation of a new educative tools (Smartphone application) based on impact of instrumental dead space reduction after initiation of protective ventilation during mechanical ventilation.
- Being tested
- Protective ventilation implementation, Protective ventilation with HME, Protective ventilation with Heated humidifier, Tidal Volume reduction
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protective ventilation implementationProcedure or surgery
In this condition, we will implement the protective ventilation related with gender and height . A blood gas will be performed at before protective ventilation implementation and at the end of this condition.Time condition 30 minutes
Protective ventilation with HMEProcedure or surgery
In this condition, the patient will received protective ventilation with a Heat Moisture Exchanger (HME). A blood gas will be performed at the end of this condition.Time condition 30 minutes
Protective ventilation with Heated humidifierProcedure or surgery
In this condition, the patient will received protective ventilation with a Heated humidifier. A blood gas will be performed at the end of this condition.Time condition 30 minutes
Tidal Volume reductionProcedure or surgery
n this condition, we will reduce Tidal volume (with smartphone application calculation) to obtain the same alveolar ventilation (PaCO2) obtained on the HME condition
| Study group | Role | What they receive |
|---|---|---|
| Protective ventilation with HME | Other | Protective ventilation + HME Receives: Procedure: Protective ventilation with HME |
| Protective ventilation with Heated humidifier | Other | Protective ventilation + HH Receives: Procedure: Protective ventilation with Heated humidifier |
| Implementation of protective ventilation | Other | Protective ventilation implementation Receives: Procedure: Protective ventilation implementation |
| Tidal Volume reduction | Other | Tidal volume reduction Receives: Procedure: Tidal Volume reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaCO2 Variation
The primary outcome is to evaluate the PaCO2 variation at the end of condition 2 (after 30 minutes with protective ventilation+ HME) and condition 4 (30 minutes after Tidal volume reduction + Heater humidifier).
Variation <= 10% of PaCO2
Measured: 60 minutes post intervention
PaCO2 Variation
The primary outcome is to evaluate the PaCO2 variation at the end of condition 2 (after 30 minutes with protective ventilation+ HME) and condition 4 (30 minutes after Tidal volume reduction + Heater humidifier).
Variation <= 10% of PaCO2
Measured: 120 minutes post intervention
Secondary outcomes (4)
Correlation between PCO2 variation and alveolar ventilation variation
We will compare PaCO2 level variation and the alveolar ventilation variation to establish correlation.
Correlation variation under 10% will be significative
Measured: 60 and 90 minutes post intervention
Hemodynamic impact vs pH
Cardiac echographic measurement (LeftVentricularEjectionFraction) in relation with acidosis status
Measured: Baseline, 30, 60, 90 and 120 minutes post intervention
Hemodynamic impact vs pH
Cardiac echographic measurement (RightVentricularEjectionFraction) in relation with acidosis status
Measured: Baseline, 30, 60, 90 and 120 minutes post intervention
Hemodynamic impact vs pH
Cardiac echographic measurement Arterial pulmonary pressure) in relation with acidosis status
Measured: Baseline, 30, 60, 90 and 120 minutes post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start1 Nov 2019
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS, HumanStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390360
- Sponsor's protocol ID
- 21750
- Acronym
- Ventilo
- Status last verified
- Mar 2023
- First submitted
- 20 Apr 2020
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Smartphone App for Initiation of Protective Ventilation. Clinical Impact of Instrumental Dead Space Reduction on Physiologic Parameter Based on the Smartphone App
- ClinicalTrials.gov ID
- NCT04390360
- Acronym / sponsor ID
- Ventilo / 21750
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 15 May 2020 (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.
Clinical evaluation of a new educative tools (Smartphone application) based on impact of instrumental dead space reduction after initiation of protective ventilation during mechanical ventilation.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Protective ventilation with HME | Other | Procedure: Protective ventilation with HMEProtective ventilation + HME |
| Protective ventilation with Heated humidifier | Other | Procedure: Protective ventilation with Heated humidifierProtective ventilation + HH |
| Implementation of protective ventilation | Other | Procedure: Protective ventilation implementationProtective ventilation implementation |
| Tidal Volume reduction | Other | Procedure: Tidal Volume reductionTidal volume reduction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years old
- Mechanical ventilation (control,assist control or SIMV mode)
- haemodynamic stability (vasopressor < 0.2 ug/kg/min)
- no prone position schedule in the next 2 hours following procedure inclusion
- presence of an Arterial catheter
Key exclusion criteria (2 listed)
- ECMO or anticipate ECMO
- body temperature < 36.0 for post operative patient (cardiac surgery)
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 |
|---|---|---|
| Protective ventilation implementationIn this condition, we will implement the protective ventilation related with gender and height . A blood gas will be performed at before protective ventilation implementation and at the end of this condition.Time condition 30 minutes | Procedure or surgery | Implementation of protective ventilation |
| Protective ventilation with HMEIn this condition, the patient will received protective ventilation with a Heat Moisture Exchanger (HME). A blood gas will be performed at the end of this condition.Time condition 30 minutes | Procedure or surgery | Protective ventilation with HME |
| Protective ventilation with Heated humidifierIn this condition, the patient will received protective ventilation with a Heated humidifier. A blood gas will be performed at the end of this condition.Time condition 30 minutes | Procedure or surgery | Protective ventilation with Heated humidifier |
| Tidal Volume reductionn this condition, we will reduce Tidal volume (with smartphone application calculation) to obtain the same alveolar ventilation (PaCO2) obtained on the HME condition | Procedure or surgery | Tidal Volume reduction |
Primary outcome
PaCO2 Variation
Time frame: 60 minutes post intervention
The primary outcome is to evaluate the PaCO2 variation at the end of condition 2 (after 30 minutes with protective ventilation+ HME) and condition 4 (30 minutes after Tidal volume reduction + Heater humidifier). Variation <= 10% of PaCO2
PaCO2 Variation
Time frame: 120 minutes post intervention
The primary outcome is to evaluate the PaCO2 variation at the end of condition 2 (after 30 minutes with protective ventilation+ HME) and condition 4 (30 minutes after Tidal volume reduction + Heater humidifier). Variation <= 10% of PaCO2
4 secondary outcomes
Correlation between PCO2 variation and alveolar ventilation variation
Time frame: 60 and 90 minutes post intervention
Hemodynamic impact vs pH
Time frame: Baseline, 30, 60, 90 and 120 minutes post intervention
Hemodynamic impact vs pH
Time frame: Baseline, 30, 60, 90 and 120 minutes post intervention
Hemodynamic impact vs pH
Time frame: Baseline, 30, 60, 90 and 120 minutes post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protective ventilation implementation, Protective ventilation with HME and Protective ventilation with Heated humidifier in people with ARDS, Human and 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 10 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François Lellouche (1-418-656-8711, 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?
PaCO2 Variation (time frame: 60 minutes post intervention). The study lists 2 primary outcomes in all. 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 10 Mar 2023.