RENOVATE Fibrosis:HFNC Versus NIPPV in Acute Respiratory Failure in Patients With Pulmonary Fibrosis

Acute Respiratory Failure Clinical Trial

— Fibrosis  

Official title:

Multicentric Randomized Controlled Pilot Study Comparing High Flow Nasal Cannula Versus NonInvasive Positive Pressure Ventilation in Acute Respiratory Failure in Patients With Pulmonary Fibrosis (RENOVATE Fibrosis)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04253405
• Other study ID #: IP-HCOR/RENOVATEfibrose
• Status: Terminated
• Phase: N/A
• Start date: December 10, 2020
• Est. completion date: August 9, 2021

Study information

• Verified date: August 2021
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A pilot multicentric randomized controlled study investigating the feasibility of recruiting 50 pulmonary fibrosis patients in acute respiratory failure within18 months. Additionally, exploratory efficacy and safety outcomes will be evaluated.

Description:

RENOVATE Fibrosis will recruit patients with pulmonary fibrosis in acute respiratory failure to be randomized to HFNC or NIPPV. Efficacy and safety outcomes measured are dyspnea variation, physiological variables (pCO2, respiratory rate, oxygenation), comfort, endotraqueal intubation rate, mortality in 28 and 90 days.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: August 9, 2021
• Est. primary completion date: August 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: Sequential adult patients 18 years of age or older admitted to the hospital with pulmonary fibrosis and acute onset of respiratory failure that meets criteria A and B bellow.

A. Pulmonary fibrosis will be defined by all of the criteria below:

• presence of Velcro-type crackles on physical examination
• imaging compatible with pulmonary fibrosis
• diffuse disease on imaging B. Acute respiratory failure (ARF) will be defined by hypoxemia evidenced by SpO2 <90% or PaO2 <60 mmHg in room air and at least two of the criteria below within the last four

weeks:

• worsening dyspnea
• worsening breathing effort
• worsening gas exchange (worsening SpO2 or paO2)
• worsening respiratory rate, above 25 irpm

Exclusion Criteria:

• Pulmonary fibrosis secondary to progressive massive fibrosis (silicosis), or any other tumor form of fibrosis;
• Significant pulmonary arterial hypertension characterized by: Right ventricular failure on Doppler echocardiogram or Cardiac index <2L / min / m2 in catheterization of right chambers;
• Pneumothorax or extensive pleural effusion as the main determinant of ARF in the assessment of the attending physician;
• Cardiogenic pulmonary congestion as the main determinant of IRPA in the assessment of the attending physician;
• Presence of delirium or non-cooperation at the time of randomization;
• Anatomical facial abnormalities;
• Incoercible vomiting or hypersecretion of the airways;
• Use of continuous VNIPP or HFNC for more than 8h before randomization;
• pregnancy;
• Refusal to participate.

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Fibrosis
• Pulmonary Fibrosis
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Device:
• High Flow Nasal Catheter
HFNC will be delivered through AIRVO2. FiO2 from 21 to 100% and heated humidified gas flow up to 60 l / min with temperature of the circuit maintained at 37 degrees. Oxygen flow will be offered through a humidified nasal catheter. Flow and FiO2 will be titrated according to the protocol to maximize the patient´s comfort and SpO2
• Noninvasive positive pressure ventilation (NIPPV)
NIPPV will be performed using a facial mask (either oronasal or full face). NIPPV will deliver pressures and FiO2 according to the protocol.

Locations

Country	Name	City	State
Brazil	Hospital de Brasilia (HOBRA)	Brasília	DF
Brazil	Hospital Nereu Ramos	Florianópolis	SC
Brazil	Hospital do Coracao	Sao Paulo
Brazil	InCor - Hospital das Clinicas da Faculdade de Medicina da USP	Sao Paulo
Brazil	Instituto de Cardiologia Dante Pazanese	São Paulo	Sao Paulo
Brazil	Hospital UNIMED Vitória	Vitória	ES

Sponsors (3)

Lead Sponsor	Collaborator
Hospital do Coracao	Fisher and Paykel Healthcare, Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comfort visual analog scale variation	Confort scale	7 days
Other	Endotracheal intubation (ETI) rate	Endotracheal intubation	7 days
Other	Mortality	Mortality in 28 days	28 days
Other	Mortality	Mortality in 90 days	90 days
Primary	Recruitment feasibility	Recruitment of 50 pulmonary fibrosis patients in acute respiratory failure in 18 months	18 months
Secondary	Dyspneia variation (Borg scale)	Borg scale	7 days
Secondary	Respiratory frequency variation	Respiratory rate	7 days
Secondary	oxygen saturation/fraction of inspired oxygen (SpO2/FiO2) variation	Oxygen index	7 days
Secondary	Carbon dioxide arterial partial pressure (PaCO2) variation	CO2 variation	7 days