Tidal Volume in Patients With de Novo Acute Hypoxemic Respiratory Failure

Study Overview
=================
Brief Summary
-----------------
Protective ventilation can be difficult to achieve during noninvasive ventilation for de novoacute hypoxemic respiratory failure (i.e., not due to exacerbation of chronic lung disease or cardiac failure).Recent data suggest patient self-inflicted lung injury (P-SILI) as a possible mechanism aggravating lung damage in these patients. The aim of this study is evaluate the tidal volume, measured by respiratory inductance plethysmography, in patients receiving different non invasive respiratory support.

Official Title
-----------------
Tidal Volume in Patients With de Novo Acute Hypoxemic Respiratory Failure Receiving Non-invasive Respiratory Supports: a Pilot Study

Conditions
-----------------
Acute Hypoxemic Respiratory Failure

Intervention / Treatment
-----------------
* Device: Ventimask
* Device: High Flow Nasal cannula (HFNC)
* Device: Helmet CPAP
* Device: Non Invasive Ventilation (NIV)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute Respiratory Failure (ARF) ( 100 <PaO2/FiO2 <300) due to Covid-19 infection Informed consent Enrollment within the first 24 hours after ARF Exclusion Criteria: Clinical, radiological or istological evidence of chronic pulmonary disease. Body Mass Index (BMI) > 30 kg/m2; Previous diagnosis of Obstructive sleep apnea syndrome (OSAS) Chest wall disease Heart failure Severe hemodynamic instability ( need for amine support) Acute coronary syndrome (ACS) Severe arrhythmia Patients unable to protect respiratory airways Respiratory arrest and need for endotracheal intubation Pregnancy Need for sedation Home long-term oxygen therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: spontaneous breathing trial<br>the patients will be asked to breathe spontaneously using their actual low oxygen flow | Device: Ventimask<br>* The patients will be asked to breathe spontaneously using their actual low oxygen flow<br>Device: High Flow Nasal cannula (HFNC)<br>* The patients will be asked to breathe using high flow nasal cannula (HFNC). Air flow will set up to 60 l/m, temperature according to patient's comfort and FiO2 in order to obtain SpO2 values >/= 92%<br>Device: Helmet CPAP<br>* The patients will be asked to breathe with Helmet. CPAP will set at 10 cmH2O and FiO2 in order to obtain SpO2 values >/= 92%<br>Device: Non Invasive Ventilation (NIV)<br>* the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface<br>|
| Active Comparator: High Flow Nasal cannula (HFNC)<br>The patients will be asked to breathe with HFNC of 40 L/min | Device: Ventimask<br>* The patients will be asked to breathe spontaneously using their actual low oxygen flow<br>Device: High Flow Nasal cannula (HFNC)<br>* The patients will be asked to breathe using high flow nasal cannula (HFNC). Air flow will set up to 60 l/m, temperature according to patient's comfort and FiO2 in order to obtain SpO2 values >/= 92%<br>Device: Helmet CPAP<br>* The patients will be asked to breathe with Helmet. CPAP will set at 10 cmH2O and FiO2 in order to obtain SpO2 values >/= 92%<br>Device: Non Invasive Ventilation (NIV)<br>* the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface<br>|
| Active Comparator: Helmet CPAP<br>the patients will be asked to breathe with the Helmet CPAP | Device: Ventimask<br>* The patients will be asked to breathe spontaneously using their actual low oxygen flow<br>Device: High Flow Nasal cannula (HFNC)<br>* The patients will be asked to breathe using high flow nasal cannula (HFNC). Air flow will set up to 60 l/m, temperature according to patient's comfort and FiO2 in order to obtain SpO2 values >/= 92%<br>Device: Helmet CPAP<br>* The patients will be asked to breathe with Helmet. CPAP will set at 10 cmH2O and FiO2 in order to obtain SpO2 values >/= 92%<br>Device: Non Invasive Ventilation (NIV)<br>* the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface<br>|
| Active Comparator: Non Invasive Ventilation (NIV)<br>the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface | Device: Ventimask<br>* The patients will be asked to breathe spontaneously using their actual low oxygen flow<br>Device: High Flow Nasal cannula (HFNC)<br>* The patients will be asked to breathe using high flow nasal cannula (HFNC). Air flow will set up to 60 l/m, temperature according to patient's comfort and FiO2 in order to obtain SpO2 values >/= 92%<br>Device: Helmet CPAP<br>* The patients will be asked to breathe with Helmet. CPAP will set at 10 cmH2O and FiO2 in order to obtain SpO2 values >/= 92%<br>Device: Non Invasive Ventilation (NIV)<br>* the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| respiratory pattern | the way the patient is breathing recorded by respiratory inductance plethysmography (RIP) | 30 minutes | 
| respiratory mechanics | the inspiratory effort of the patient recorded by esophageal pressure | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in Arterial Blood Gases (ABGs) | Arterial Blood Gases, namely arterial oxygen (PaO2) and carbon dioxyde (PaCO2) tension will be analyzed from a sample taken from the arterial artery | immediately after intervention | 
| Dyspnea score | Dyspnea will be recorded using the Borg scale that is a numeric scale where 0 is no dyspnea and 10 the maximal dyspnea that a patient can imagine | immediately after intervention | 
| Comfort score | this will be assessed using a dedicated visual analog scale (VAS with a length of 20 cm) | immediately after intervention | 
| Blood pressure (BP) and Heart rate (HR) measurements | blood pressure and heart rate will be assessed | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
De novo, ARF