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

IRCCS Azienda Ospedaliero-Universitaria di Bologna21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Hypoxemic Respiratory Failure

Interventions

VentimaskDEVICE

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

High Flow Nasal cannula (HFNC)DEVICE

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%

Helmet CPAPDEVICE

The patients will be asked to breathe with Helmet. CPAP will set at 10 cmH2O and FiO2 in order to obtain SpO2 values \>/= 92%

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

IRCCS Policlinico di Sant'Orsola

Bologna, Italy

Outcomes

Primary Outcomes

respiratory pattern

the way the patient is breathing recorded by respiratory inductance plethysmography (RIP)

Time frame: 30 minutes

respiratory mechanics

the inspiratory effort of the patient recorded by esophageal pressure

Time frame: 30 minutes

Secondary Outcomes

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

Time frame: 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

Time frame: immediately after intervention

Comfort score

this will be assessed using a dedicated visual analog scale (VAS with a length of 20 cm)

Time frame: immediately after intervention

Blood pressure (BP) and Heart rate (HR) measurements

blood pressure and heart rate will be assessed

Time frame: 30 minutes

Data from ClinicalTrials.gov

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