DENOVT: Tidal Volume in Patients With "de Novo" Acute Hypoxemic Respiratory Failure
Study Details
Study Description
Brief Summary
Protective ventilation can be difficult to achieve during noninvasive ventilation for "de novo"acute 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: spontaneous breathing trial the patients will be asked to breathe spontaneously using their actual low oxygen flow |
Device: Ventimask
The patients will be asked to breathe spontaneously using their actual low oxygen flow
Device: High Flow Nasal cannula (HFNC)
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%
Device: Helmet CPAP
The patients will be asked to breathe with Helmet. CPAP will set at 10 cmH2O and FiO2 in order to obtain SpO2 values >/= 92%
Device: Non Invasive Ventilation (NIV)
the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface
|
| Active Comparator: High Flow Nasal cannula (HFNC) The patients will be asked to breathe with HFNC of 40 L/min |
Device: Ventimask
The patients will be asked to breathe spontaneously using their actual low oxygen flow
Device: High Flow Nasal cannula (HFNC)
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%
Device: Helmet CPAP
The patients will be asked to breathe with Helmet. CPAP will set at 10 cmH2O and FiO2 in order to obtain SpO2 values >/= 92%
Device: Non Invasive Ventilation (NIV)
the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface
|
| Active Comparator: Helmet CPAP the patients will be asked to breathe with the Helmet CPAP |
Device: Ventimask
The patients will be asked to breathe spontaneously using their actual low oxygen flow
Device: High Flow Nasal cannula (HFNC)
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%
Device: Helmet CPAP
The patients will be asked to breathe with Helmet. CPAP will set at 10 cmH2O and FiO2 in order to obtain SpO2 values >/= 92%
Device: Non Invasive Ventilation (NIV)
the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface
|
| Active Comparator: Non Invasive Ventilation (NIV) the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface |
Device: Ventimask
The patients will be asked to breathe spontaneously using their actual low oxygen flow
Device: High Flow Nasal cannula (HFNC)
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%
Device: Helmet CPAP
The patients will be asked to breathe with Helmet. CPAP will set at 10 cmH2O and FiO2 in order to obtain SpO2 values >/= 92%
Device: Non Invasive Ventilation (NIV)
the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface
|
Outcome Measures
Primary Outcome Measures
- respiratory pattern [30 minutes]
the way the patient is breathing recorded by respiratory inductance plethysmography (RIP)
- respiratory mechanics [30 minutes]
the inspiratory effort of the patient recorded by esophageal pressure
Secondary Outcome Measures
- changes in Arterial Blood Gases (ABGs) [immediately after intervention]
Arterial Blood Gases, namely arterial oxygen (PaO2) and carbon dioxyde (PaCO2) tension will be analyzed from a sample taken from the arterial artery
- Dyspnea score [immediately after intervention]
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
- Comfort score [immediately after intervention]
this will be assessed using a dedicated visual analog scale (VAS with a length of 20 cm)
- Blood pressure (BP) and Heart rate (HR) measurements [30 minutes]
blood pressure and heart rate will be assessed
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IRCCS Policlinico di Sant'Orsola | Bologna | Italy | 40138 |
Sponsors and Collaborators
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Investigators
- Principal Investigator: Stefano Nava, MD, Alma Mater Studiorum University of Bologna (IT)- Director of Respiratory and Critical Care Unit/ IRCSS S.Orsola-Malpighi University Hospital, Bologna (IT)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 691/2020/Sper/AOUBo