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Completed

NCT Number: NCT04741659

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

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.

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Key information

Conditions

Acute Hypoxemic Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Policlinico di Sant'Orsola

Bologna, 40138, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ventimask

Device

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 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%

Non invasive ventilation (NIV)

Device

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

Primary outcomes

  1. respiratory pattern

    Time frame: 30 minutes

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

  2. respiratory mechanics

    Time frame: 30 minutes

    the inspiratory effort of the patient recorded by esophageal pressure

Secondary outcomes

  1. changes in Arterial Blood Gases (ABGs)

    Time frame: immediately after intervention

    Arterial Blood Gases, namely arterial oxygen (PaO2) and carbon dioxyde (PaCO2) tension will be analyzed from a sample taken from the arterial artery

  2. Dyspnea score

    Time frame: immediately after intervention

    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

  3. Comfort score

    Time frame: immediately after intervention

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

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

    Time frame: 30 minutes

    blood pressure and heart rate will be assessed

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Acronym: DENOVT

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2021
Registry last updated
Nov 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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