Tidal Volume in Patients With de Novo Acute Hypoxemic Respiratory Failure

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04741659

Acronym

DENOVT

Enrollment

Registered

2021-02-05

Start date

2021-01-20

Completion date

2021-07-30

Last updated

2021-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Hypoxemic Respiratory Failure

Keywords

De novo, ARF

Brief summary

Protective ventilation can be difficult to achieve during noninvasive ventilation for de novoacute 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.

Interventions

DEVICEVentimask

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

DEVICEHigh 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%

DEVICEHelmet 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%

DEVICENon Invasive Ventilation (NIV)

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

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

Design outcomes

Primary

Measure	Time frame	Description
respiratory pattern	30 minutes	the way the patient is breathing recorded by respiratory inductance plethysmography (RIP)
respiratory mechanics	30 minutes	the inspiratory effort of the patient recorded by esophageal pressure

Secondary

Measure	Time frame	Description
changes in Arterial Blood Gases (ABGs)	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
Dyspnea score	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
Comfort score	immediately after intervention	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	30 minutes	blood pressure and heart rate will be assessed

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026