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

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

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 Overview

• Status: Completed
• Conditions: Acute Hypoxemic Respiratory Failure
• Intervention / Treatment: Device: Ventimask; Device: High Flow Nasal cannula (HFNC); Device: Helmet CPAP; Device: Non Invasive Ventilation (NIV)

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40138
    • IRCCS Policlinico di Sant'Orsola

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / 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

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
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
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
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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (ACTUAL): January 20, 2021
• Primary Completion (ACTUAL): March 31, 2021
• Study Completion (ACTUAL): July 30, 2021

Study Registration Dates

• First Submitted: February 1, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (ACTUAL): February 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 2, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: De novo; ARF
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 691/2020/Sper/AOUBo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No