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

Primary Purpose

Acute Hypoxemic Respiratory Failure

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Ventimask

High Flow Nasal cannula (HFNC)

Helmet CPAP

Non Invasive Ventilation (NIV)

About this trial

This is an interventional treatment trial for Acute Hypoxemic Respiratory Failure focused on measuring De novo, ARF

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

IRCCS Policlinico di Sant'Orsola

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Arm Label

spontaneous breathing trial

High Flow Nasal cannula (HFNC)

Helmet CPAP

Non Invasive Ventilation (NIV)

Arm Description

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

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

the patients will be asked to breathe with the Helmet CPAP

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

Outcomes

Primary Outcome Measures

respiratory pattern

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

respiratory mechanics

the inspiratory effort of the patient recorded by esophageal pressure

Secondary Outcome Measures

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

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

Comfort score

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

blood pressure and heart rate will be assessed

Full Information

NCT ID

NCT04741659

First Posted

February 1, 2021

Last Updated

November 2, 2021

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

1. Study Identification

Unique Protocol Identification Number

NCT04741659

Brief Title

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

Acronym

DENOVT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

January 20, 2021 (Actual)

Primary Completion Date

March 31, 2021 (Actual)

Study Completion Date

July 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Hypoxemic Respiratory Failure

Keywords

De novo, ARF

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

spontaneous breathing trial

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

High Flow Nasal cannula (HFNC)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Helmet CPAP

Arm Type

Active Comparator

Arm Description

the patients will be asked to breathe with the Helmet CPAP

Arm Title

Non Invasive Ventilation (NIV)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Ventimask

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

High Flow Nasal cannula (HFNC)

Intervention Description

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%

Intervention Type

Device

Intervention Name(s)

Helmet CPAP

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Non Invasive Ventilation (NIV)

Intervention Description

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

Primary Outcome Measure Information:

Title

respiratory pattern

Description

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

Time Frame

30 minutes

Title

respiratory mechanics

Description

the inspiratory effort of the patient recorded by esophageal pressure

Time Frame

30 minutes

Secondary Outcome Measure Information:

Title

changes in Arterial Blood Gases (ABGs)

Description

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

Title

Dyspnea score

Description

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

Title

Comfort score

Description

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

Time Frame

immediately after intervention

Title

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

Description

blood pressure and heart rate will be assessed

Time Frame

30 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stefano Nava, MD

Organizational Affiliation

Alma Mater Studiorum University of Bologna (IT)- Director of Respiratory and Critical Care Unit/ IRCSS S.Orsola-Malpighi University Hospital, Bologna (IT)

Official's Role

Principal Investigator

Facility Information:

Facility Name

IRCCS Policlinico di Sant'Orsola

City

Bologna

ZIP/Postal Code

40138

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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