Mechanical VentilationNCT03930147
Ventilation With ASV Mode in Children
A study testing ASV ventilation in people with Mechanical Ventilation, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
ASV mode of ventilation is an automatic mode with closed-loop control used for mechanical invasive ventilation in intubated patients. It has been studied in adult patients but not in children. This interventional physiology study will include 40 children on mechanical invasive ventilation. Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- ASV ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Sep 2019to 5 Dec 2023
- 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 Up to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children on invasive mechanical ventilation admitted in the Pediatric Intensive Care Unit at Lausanne University Hospital
- Body weight > 6kg
- Absence of pulmonary comorbidity
- Age < 10 years
Who cannot join
- Patient already included in other interventional clinical study
- body weight < 6kg
- age > 10 years
- more than 20% of air leak around endotracheal tube
- chronic or acute pulmonary disease (ARDS, cystic fibrosis, severe asthma, lobectomy, severe bronchomalacia or severe tracheomalacia)
- severe pulmonary hypertension on inhaled nitric oxide treatment
- severe hemodynamic instability (more than 0.5mcg/kg/min of norepinephrine infusion or other high dose vasoactive agent infusion)
- intracranial hypertension (more than 20mmHg if measured) or suspected intracranial hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monocentric Interventional Study on the Feasibility of the Invasive Mechanical Ventilation Mode "Adaptive Support Ventilation, ASV" in a Pediatric Population and Comparison to Pressure-Control and Pressure-Support Ventilation Modes
ASV mode of ventilation is an automatic mode with closed-loop control used for mechanical invasive ventilation in intubated patients. It has been studied in adult patients but not in children.
This interventional physiology study will include 40 children on mechanical invasive ventilation.
Read the detailed description
The objective of the study is to assess the feasibility of ASV in children and compare physiologic values on ASV mode to Pressure-Control and Pressure-Support mode of ventilation regarding the participant is on active or passive ventilation phase.
Physiologic values will be monitored on different modes of ventilation in a randomized order. Each participant will be his own control regarding the different modes of ventilation. Monitoring will be done during 90 minutes for each mode of ventilation.
Participant will have two different phases of ventilation. The first one is the passive phase (participant does not trigger the ventilator cycle sustainly) in which ASV and Pressure-Control Ventilation will be performed in a randomized order. The second phase will be the active ventilation phase (participant does trigger the ventilator cycle sustainly) in which ASV and Pressure-Support Ventilation will be performed in a randomized order.
- Conditions
- Mechanical Ventilation
- Being tested
- ASV ventilation
- Keywords
- Children, Ventilation, Closed-loop mechanical ventilation, Adaptive support ventilation
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASV ventilationProcedure or surgery
Ventilation on ASV mode
| Study group | Role | What they receive |
|---|---|---|
| Passive phase, Pressure-Control Ventilation / ASV order | Experimental | 90 minutes of Pressure-Control Ventilation, change to ASV mode with 15 to 30 minutes of washout, 90 minutes of ASV. Return to Pressure-Control Ventilation mode at the end of the intervention. Receives: Procedure: ASV ventilation |
| Passive phase, ASV / Pressure-Control Ventilation order | Experimental | 90 minutes of ASV, change to Pressure-Control Ventilation mode with 15 to 30 minutes of washout, 90 minutes of Pressure-Control Ventilation. Receives: Procedure: ASV ventilation |
| Active phase, Pressure-Support / ASV order | Experimental | 90 minutes of Pressure-Support Ventilation, change to ASV mode with 15 to 30 minutes of washout, 90 minutes of ASV. Return to Pressure-Support Ventilation at the end of the intervention. Receives: Procedure: ASV ventilation |
| Active phase, ASV / Pressure-Support order | Experimental | 90 minutes of ASV, change to Pressure-Support Ventilation with 15 to 30 minutes of washout, 90 minutes of Pressure-Support Ventilation. Receives: Procedure: ASV ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of respiratory rate
Physiological respiratory value of mechanical ventilation
Measured: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Change of tidal volume
Physiological respiratory value of mechanical ventilation
Measured: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Change of peak inspiratory pressure
Physiological respiratory value of mechanical ventilation
Measured: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Secondary outcomes (20)
Evolution of Minute Ventilation
Physiological respiratory value of mechanical ventilation
Measured: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of Mean airway pressure
Physiological respiratory value of mechanical ventilation
Measured: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of inspiratory time
Physiological respiratory value of mechanical ventilation
Measured: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of ratio inspiratory time/expiratory time
Physiological respiratory value of mechanical ventilation
Measured: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of Crs (respiratory system compliance calculated by the ventilator)
Physiological respiratory value of mechanical ventilation
Measured: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of respiratory system resistance
Physiological respiratory value of mechanical ventilation
Measured: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of respiratory system time constant
Physiological respiratory value of mechanical ventilation
Measured: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of positive end expiratory pressure (PEEP)
Physiological respiratory value of mechanical ventilation
Measured: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of the variation of respiratory rate
Physiological respiratory value of mechanical ventilation
Measured: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of the variation of peak inspiratory pressure
Physiological respiratory value of mechanical ventilation
Measured: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of end-tidal CO2
Physiological respiratory value of mechanical ventilation
Measured: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of the variation of end-tidal CO2
Physiological respiratory value of mechanical ventilation
Measured: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of transcutaneous CO2
Physiological respiratory value of mechanical ventilation
Measured: Recording every 5 minutes during each monitoring phase of 90 minutes, 360 minutes
Evolution of variation of transcutaneous CO2
Physiological respiratory value of mechanical ventilation
Measured: Recording every 5 minutes during each monitoring phase of 90 minutes, 360 minutes
Evolution of inspired oxygen fraction
Physiological respiratory value of mechanical ventilation
Measured: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of variation of inspired oxygen fraction
Physiological respiratory value of mechanical ventilation
Measured: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of transcutaneous oxygen saturation
Physiological respiratory value of mechanical ventilation
Measured: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of variation of transcutaneous oxygen saturation
Physiological respiratory value of mechanical ventilation
Measured: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of the work load of mechanical ventilation for doctor
Recording of all modification done on ventilator parameters done by doctor during each monitoring phase
Measured: monitoring phase of 90 minutes
Evolution of mechanical ventilation tolerance
Recording of all sedation drugs administered to the participant during each monitoring phase
Measured: monitoring phase of 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start13 Sep 2019
- Primary completion5 Dec 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies 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
- Crossover
- Model description
- Two different phases of ventilation (passive versus active) will be monitored in each patient. In each phase, two different modes of ventilation will be performed in a randomized order and will be monitored (Pressure-Control Ventilation and ASV during the passive ventilation phase, Pressure-Support Ventilation and ASV during the active ventilation phase). Washout periods will be performed between the different modes of ventilation.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FERRY Thomas, University of Lausanne Hospitals
- Investigators
- Thomas Ferry, MD, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930147
- Sponsor's protocol ID
- ASV ventilation in children
- Status last verified
- Dec 2023
- First submitted
- 12 Apr 2019
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Interventional Study on the Feasibility of the Invasive Mechanical Ventilation Mode "Adaptive Support Ventilation, ASV" in a Pediatric Population and Comparison to Pressure-Control and Pressure-Support Ventilation Modes
- ClinicalTrials.gov ID
- NCT03930147
- Acronym / sponsor ID
- ASV ventilation in children
- Conditions
- Mechanical Ventilation
- Keywords
- Children, Ventilation, Closed-loop mechanical ventilation, Adaptive support ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- 13 Sep 2019 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 29 Apr 2019 (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.
ASV mode of ventilation is an automatic mode with closed-loop control used for mechanical invasive ventilation in intubated patients. It has been studied in adult patients but not in children.
This interventional physiology study will include 40 children on mechanical invasive ventilation.
Detailed description
The objective of the study is to assess the feasibility of ASV in children and compare physiologic values on ASV mode to Pressure-Control and Pressure-Support mode of ventilation regarding the participant is on active or passive ventilation phase.
Physiologic values will be monitored on different modes of ventilation in a randomized order. Each participant will be his own control regarding the different modes of ventilation. Monitoring will be done during 90 minutes for each mode of ventilation.
Participant will have two different phases of ventilation. The first one is the passive phase (participant does not trigger the ventilator cycle sustainly) in which ASV and Pressure-Control Ventilation will be performed in a randomized order. The second phase will be the active ventilation phase (participant does trigger the ventilator cycle sustainly) in which ASV and Pressure-Support Ventilation will be performed in a randomized order.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Two different phases of ventilation (passive versus active) will be monitored in each patient. In each phase, two different modes of ventilation will be performed in a randomized order and will be monitored (Pressure-Control Ventilation and ASV during the passive ventilation phase, Pressure-Support Ventilation and ASV during the active ventilation phase). Washout periods will be performed between the different modes of ventilation.
| Arm | Type | Receives |
|---|---|---|
| Passive phase, Pressure-Control Ventilation / ASV order | Experimental | Procedure: ASV ventilation90 minutes of Pressure-Control Ventilation, change to ASV mode with 15 to 30 minutes of washout, 90 minutes of ASV. Return to Pressure-Control Ventilation mode at the end of the intervention. |
| Passive phase, ASV / Pressure-Control Ventilation order | Experimental | Procedure: ASV ventilation90 minutes of ASV, change to Pressure-Control Ventilation mode with 15 to 30 minutes of washout, 90 minutes of Pressure-Control Ventilation. |
| Active phase, Pressure-Support / ASV order | Experimental | Procedure: ASV ventilation90 minutes of Pressure-Support Ventilation, change to ASV mode with 15 to 30 minutes of washout, 90 minutes of ASV. Return to Pressure-Support Ventilation at the end of the intervention. |
| Active phase, ASV / Pressure-Support order | Experimental | Procedure: ASV ventilation90 minutes of ASV, change to Pressure-Support Ventilation with 15 to 30 minutes of washout, 90 minutes of Pressure-Support Ventilation. |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- children on invasive mechanical ventilation admitted in the Pediatric Intensive Care Unit at Lausanne University Hospital
- Body weight > 6kg
- Absence of pulmonary comorbidity
- Age < 10 years
Key exclusion criteria (8 listed)
- Patient already included in other interventional clinical study
- body weight < 6kg
- age > 10 years
- more than 20% of air leak around endotracheal tube
- chronic or acute pulmonary disease (ARDS, cystic fibrosis, severe asthma, lobectomy, severe bronchomalacia or severe tracheomalacia)
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 |
|---|---|---|
| ASV ventilationVentilation on ASV mode | Procedure or surgery | Active phase, ASV / Pressure-Support order, Active phase, Pressure-Support / ASV order, Passive phase, ASV / Pressure-Control Ventilation order, Passive phase, Pressure-Control Ventilation / ASV order |
Primary outcome
Change of respiratory rate
Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Physiological respiratory value of mechanical ventilation
Change of tidal volume
Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Physiological respiratory value of mechanical ventilation
Change of peak inspiratory pressure
Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Physiological respiratory value of mechanical ventilation
20 secondary outcomes
Evolution of Minute Ventilation
Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of Mean airway pressure
Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of inspiratory time
Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of ratio inspiratory time/expiratory time
Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of Crs (respiratory system compliance calculated by the ventilator)
Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of respiratory system resistance
Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of respiratory system time constant
Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of positive end expiratory pressure (PEEP)
Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of the variation of respiratory rate
Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of the variation of peak inspiratory pressure
Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of end-tidal CO2
Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of the variation of end-tidal CO2
Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of transcutaneous CO2
Time frame: Recording every 5 minutes during each monitoring phase of 90 minutes, 360 minutes
Evolution of variation of transcutaneous CO2
Time frame: Recording every 5 minutes during each monitoring phase of 90 minutes, 360 minutes
Evolution of inspired oxygen fraction
Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of variation of inspired oxygen fraction
Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of transcutaneous oxygen saturation
Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of variation of transcutaneous oxygen saturation
Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Evolution of the work load of mechanical ventilation for doctor
Time frame: monitoring phase of 90 minutes
Evolution of mechanical ventilation tolerance
Time frame: monitoring phase of 90 minutes
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 13 Dec 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.
Thomas Ferry, MD principal investigator
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASV ventilation in people with Mechanical Ventilation, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 4 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: finished, as of the sponsor's last update on 13 Dec 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 Switzerland. 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?
Change of respiratory rate (time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes). The study lists 3 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 13 Dec 2023.