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

Not Applicable

Completed

• Conditions: Acute Hypoxemic Respiratory Failure
• Interventions: Device: Ventimask; Device: High Flow Nasal cannula (HFNC); Device: Helmet CPAP; Device: Non Invasive Ventilation (NIV)

• Registration Number: NCT04741659
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-20
• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-05
• Primary Completion: 2021-03-31
• Study Completion: 2021-07-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-02
• Last Update Posted: 2021-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
spontaneous breathing trial	Non Invasive Ventilation (NIV)	the patients will be asked to breathe spontaneously using their actual low oxygen flow
High Flow Nasal cannula (HFNC)	Ventimask	The patients will be asked to breathe with HFNC of 40 L/min
High Flow Nasal cannula (HFNC)	Helmet CPAP	The patients will be asked to breathe with HFNC of 40 L/min
High Flow Nasal cannula (HFNC)	Non Invasive Ventilation (NIV)	The patients will be asked to breathe with HFNC of 40 L/min
Non Invasive Ventilation (NIV)	Helmet CPAP	the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface
spontaneous breathing trial	Helmet CPAP	the patients will be asked to breathe spontaneously using their actual low oxygen flow
High Flow Nasal cannula (HFNC)	High Flow Nasal cannula (HFNC)	The patients will be asked to breathe with HFNC of 40 L/min
Helmet CPAP	High Flow Nasal cannula (HFNC)	the patients will be asked to breathe with the Helmet CPAP
spontaneous breathing trial	High Flow Nasal cannula (HFNC)	the patients will be asked to breathe spontaneously using their actual low oxygen flow
spontaneous breathing trial	Ventimask	the patients will be asked to breathe spontaneously using their actual low oxygen flow
Helmet CPAP	Ventimask	the patients will be asked to breathe with the Helmet CPAP
Helmet CPAP	Helmet CPAP	the patients will be asked to breathe with the Helmet CPAP
Helmet CPAP	Non Invasive Ventilation (NIV)	the patients will be asked to breathe with the Helmet CPAP
Non Invasive Ventilation (NIV)	High Flow Nasal cannula (HFNC)	the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface
Non Invasive Ventilation (NIV)	Non Invasive Ventilation (NIV)	the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface
Non Invasive Ventilation (NIV)	Ventimask	the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Blood pressure (BP) and Heart rate (HR) measurements	30 minutes	blood pressure and heart rate will be assessed
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
Comfort score	immediately after intervention	this will be assessed using a dedicated visual analog scale (VAS with a length of 20 cm)
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

Trial Locations

Locations (1)

IRCCS Policlinico di Sant'Orsola; 🇮🇹 Bologna, Italy