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

NCT04741659 | Completed

• 1 other identifier: 691/2020/Sper/AOUBo
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Hypoxemic Respiratory Failure

Keywords

De novo; ARF

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• changes in Arterial Blood Gases (ABGs)

  immediately after intervention

• Dyspnea score

  immediately after intervention

• Comfort score

  immediately after intervention

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

  30 minutes

Study Arms (4)

spontaneous breathing trial

PLACEBO COMPARATOR

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

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

High Flow Nasal cannula (HFNC)

ACTIVE COMPARATOR

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

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

Helmet CPAP

ACTIVE COMPARATOR

the patients will be asked to breathe with the Helmet CPAP

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

Non Invasive Ventilation (NIV)

ACTIVE COMPARATOR

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

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

Interventions

Ventimask DEVICE

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

Helmet CPAP; High Flow Nasal cannula (HFNC); Non Invasive Ventilation (NIV); spontaneous breathing trial

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 CPAP; High Flow Nasal cannula (HFNC); Non Invasive Ventilation (NIV); spontaneous breathing trial

Helmet CPAP DEVICE

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

Helmet CPAP; High Flow Nasal cannula (HFNC); Non Invasive Ventilation (NIV); spontaneous breathing trial

Non Invasive Ventilation (NIV) DEVICE

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

Helmet CPAP; High Flow Nasal cannula (HFNC); Non Invasive Ventilation (NIV); spontaneous breathing trial

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute Respiratory Failure (ARF) ( 100 \<PaO2/FiO2 \<300) due to Covid-19 infection
• Informed consent
• Enrollment within the first 24 hours after ARF

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Policlinico di Sant'Orsola

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stefano Nava, Professor of Respiratory Medicine/ Alma Mater Studiorum University of Bologna (IT)- Director of Respiratory and Critical Care Unit/ S.Orsola-Malpighi University Hospital, Bologna (IT)

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 5, 2021
• Study Start: January 20, 2021
• Primary Completion: March 31, 2021
• Study Completion: July 30, 2021
• Last Updated: November 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)