Smartphone Application for Initiation of Protective Ventilation. Clinical Impact of Instrumental Dead Space Reduction

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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ARDS, Human, Mechanical Ventilation Complication, Humidifier Lung

Intervention / Treatment
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* Procedure: Protective ventilation implementation
* Procedure: Protective ventilation with HME
* Procedure: Protective ventilation with Heated humidifier
* Procedure: Tidal Volume reduction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: ECMO or anticipate ECMO body temperature < 36.0 for post operative patient (cardiac surgery)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Protective ventilation with HME<br>Protective ventilation + HME | Procedure: Protective ventilation with HME<br>* 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<br>|
| Other: Protective ventilation with Heated humidifier<br>Protective ventilation + HH | Procedure: Protective ventilation with Heated humidifier<br>* 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<br>|
| Other: Implementation of protective ventilation<br>Protective ventilation implementation | Procedure: Protective ventilation implementation<br>* 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<br>|
| Other: Tidal Volume reduction<br>Tidal volume reduction | Procedure: Tidal Volume reduction<br>* n this condition, we will reduce Tidal volume (with smartphone application calculation) to obtain the same alveolar ventilation (PaCO2) obtained on the HME condition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 120 minutes post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 60 and 90 minutes post intervention | 
| Hemodynamic impact vs pH | Cardiac echographic measurement (LeftVentricularEjectionFraction) in relation with acidosis status | Baseline, 30, 60, 90 and 120 minutes post intervention | 
| Hemodynamic impact vs pH | Cardiac echographic measurement (RightVentricularEjectionFraction) in relation with acidosis status | Baseline, 30, 60, 90 and 120 minutes post intervention | 
| Hemodynamic impact vs pH | Cardiac echographic measurement Arterial pulmonary pressure) in relation with acidosis status | Baseline, 30, 60, 90 and 120 minutes post intervention |