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出境医 / 临床实验 / Ventilation With ASV Mode in Children
Ventilation With ASV Mode in Children
Study Description
Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Mechanical Ventilation | Procedure: ASV ventilation | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Intervention 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) |
| Primary Purpose: | Other |
| 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 |
| Actual Study Start Date : | September 13, 2019 |
| Estimated Primary Completion Date : | July 31, 2022 |
| Estimated Study Completion Date : | July 31, 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Passive phase, Pressure-Control Ventilation / ASV order
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.
|
Procedure: ASV ventilation
Ventilation on ASV mode
|
|
Experimental: Passive phase, ASV / Pressure-Control Ventilation order
90 minutes of ASV, change to Pressure-Control Ventilation mode with 15 to 30 minutes of washout, 90 minutes of Pressure-Control Ventilation.
|
Procedure: ASV ventilation
Ventilation on ASV mode
|
|
Experimental: Active phase, Pressure-Support / ASV order
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.
|
Procedure: ASV ventilation
Ventilation on ASV mode
|
|
Experimental: Active phase, ASV / Pressure-Support order
90 minutes of ASV, change to Pressure-Support Ventilation with 15 to 30 minutes of washout, 90 minutes of Pressure-Support Ventilation.
|
Procedure: ASV ventilation
Ventilation on ASV mode
|
Outcome Measures
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- Evolution of Minute Ventilation [ Time Frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes ]Physiological respiratory value of mechanical ventilation
- Evolution of Mean airway pressure [ Time Frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes ]Physiological respiratory value of mechanical ventilation
- Evolution of inspiratory time [ Time Frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes ]Physiological respiratory value of mechanical ventilation
- Evolution of ratio inspiratory time/expiratory time [ Time Frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes ]Physiological respiratory value of mechanical ventilation
- Evolution of Crs (respiratory system compliance calculated by the ventilator) [ Time Frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes ]Physiological respiratory value of mechanical ventilation
- Evolution of respiratory system resistance [ Time Frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes ]Physiological respiratory value of mechanical ventilation
- Evolution of respiratory system time constant [ Time Frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes ]Physiological respiratory value of mechanical ventilation
- Evolution of positive end expiratory pressure (PEEP) [ Time Frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes ]Physiological respiratory value of mechanical ventilation
- Evolution of the variation of respiratory rate [ Time Frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes ]Physiological respiratory value of mechanical ventilation
- Evolution of the variation of peak inspiratory pressure [ Time Frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes ]Physiological respiratory value of mechanical ventilation
- Evolution of end-tidal CO2 [ Time Frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes ]Physiological respiratory value of mechanical ventilation
- Evolution of the variation of end-tidal CO2 [ Time Frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes ]Physiological respiratory value of mechanical ventilation
- Evolution of transcutaneous CO2 [ Time Frame: Recording every 5 minutes during each monitoring phase of 90 minutes, 360 minutes ]Physiological respiratory value of mechanical ventilation
- Evolution of variation of transcutaneous CO2 [ Time Frame: Recording every 5 minutes during each monitoring phase of 90 minutes, 360 minutes ]Physiological respiratory value of mechanical ventilation
- Evolution of inspired oxygen fraction [ Time Frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes ]Physiological respiratory value of mechanical ventilation
- Evolution of variation of inspired oxygen fraction [ Time Frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes ]Physiological respiratory value of mechanical ventilation
- Evolution of transcutaneous oxygen saturation [ Time Frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes ]Physiological respiratory value of mechanical ventilation
- Evolution of variation of transcutaneous oxygen saturation [ Time Frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes ]Physiological respiratory value of mechanical ventilation
- Evolution of the work load of mechanical ventilation for doctor [ Time Frame: monitoring phase of 90 minutes ]Recording of all modification done on ventilator parameters done by doctor during each monitoring phase
- Evolution of mechanical ventilation tolerance [ Time Frame: monitoring phase of 90 minutes ]Recording of all sedation drugs administered to the participant during each monitoring phase
Eligibility Criteria
| Ages Eligible for Study: | up to 10 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Contacts
| Contact: Thomas Ferry, MD | +41795563626 | thomas.ferry@chuv.ch | |
| Contact: Marie-Helene Perez, MD | +41795564082 | marie-helene.perez@chuv.ch |
Locations
| Switzerland | |
| Lausanne University Hospital | Recruiting |
| Lausanne, Switzerland, 1011 | |
| Contact: Thomas Ferry, MD +41795563626 thomas.ferry@chuv.ch | |
| Sub-Investigator: David Longchamp, MD | |
| Sub-Investigator: Julia Natterer, MD | |
| Sub-Investigator: Vivianne Amiet, MD | |
| Sub-Investigator: Lise Piquilloud, MD | |
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
| Principal Investigator: | Thomas Ferry, MD | Lausanne University Hospital |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 12, 2019 | ||||||||
| First Posted Date ICMJE | April 29, 2019 | ||||||||
| Last Update Posted Date | November 27, 2020 | ||||||||
| Actual Study Start Date ICMJE | September 13, 2019 | ||||||||
| Estimated Primary Completion Date | July 31, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Ventilation With ASV Mode in Children | ||||||||
| Official Title ICMJE | 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 | ||||||||
| Brief 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. |
||||||||
| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Intervention 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. Primary Purpose: Other |
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| Condition ICMJE | Mechanical Ventilation | ||||||||
| Intervention ICMJE | Procedure: ASV ventilation
Ventilation on ASV mode
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
40 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | July 31, 2022 | ||||||||
| Estimated Primary Completion Date | July 31, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | up to 10 Years (Child) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Switzerland | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03930147 | ||||||||
| Other Study ID Numbers ICMJE | ASV ventilation in children | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | FERRY Thomas, University of Lausanne Hospitals | ||||||||
| Study Sponsor ICMJE | University of Lausanne Hospitals | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | University of Lausanne Hospitals | ||||||||
| Verification Date | November 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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