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

Acute Hypoxemic Respiratory Failure Clinical Trial

— DENOVT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04741659
• Other study ID #: 691/2020/Sper/AOUBo
• Status: Completed
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: July 30, 2021

Study information

• Verified date: November 2021
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 30, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Hypoxemic Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Ventimask
The patients will be asked to breathe spontaneously using their actual low oxygen flow
• 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%
• 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%
• Non Invasive Ventilation (NIV)
the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface

Locations

Country	Name	City	State
Italy	IRCCS Policlinico di Sant'Orsola	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	respiratory pattern	the way the patient is breathing recorded by respiratory inductance plethysmography (RIP)	30 minutes
Primary	respiratory mechanics	the inspiratory effort of the patient recorded by esophageal pressure	30 minutes
Secondary	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
Secondary	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
Secondary	Comfort score	this will be assessed using a dedicated visual analog scale (VAS with a length of 20 cm)	immediately after intervention
Secondary	Blood pressure (BP) and Heart rate (HR) measurements	blood pressure and heart rate will be assessed	30 minutes