Tidal Volume in Patients With "de Novo" Acute Hypoxemic Respiratory Failure (DENOVT)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Completed

Conditions: Acute Hypoxemic Respiratory Failure

Treatments: Device: Non Invasive Ventilation (NIV); Device: Ventimask; Device: Helmet CPAP; Device: High Flow Nasal cannula (HFNC)

Study type: Interventional

Funder types: Other

Identifiers

NCT04741659

691/2020/Sper/AOUBo

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 4 patient groups, including a placebo group

spontaneous breathing trial

Placebo Comparator group

Description:

the patients will be asked to breathe spontaneously using their actual low oxygen flow

Treatment:

Device: Non Invasive Ventilation (NIV)

Device: Ventimask

Device: High Flow Nasal cannula (HFNC)

Device: Helmet CPAP

High Flow Nasal cannula (HFNC)

Active Comparator group

Description:

The patients will be asked to breathe with HFNC of 40 L/min

Treatment:

Device: Non Invasive Ventilation (NIV)

Device: Ventimask

Device: High Flow Nasal cannula (HFNC)

Device: Helmet CPAP

Helmet CPAP

Active Comparator group

Description:

the patients will be asked to breathe with the Helmet CPAP

Treatment:

Device: Non Invasive Ventilation (NIV)

Device: Ventimask

Device: High Flow Nasal cannula (HFNC)

Device: Helmet CPAP

Non Invasive Ventilation (NIV)

Active Comparator group

Description:

the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface

Treatment:

Device: Non Invasive Ventilation (NIV)

Device: Ventimask

Device: High Flow Nasal cannula (HFNC)

Device: Helmet CPAP