Clinical trial NCT04253405: RENOVATE Fibrosis:HFNC Versus NIPPV in Acute Respiratory Failure in Patients With Pulmonary 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Respiratory Failure
Pulmonary Fibrosis
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
name: Fisher and Paykel Healthcare
First posted: 2020-02-05
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomized controlled study
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment feasibility
timeFrame: 18 months
Secondary outcomes:
measure: Dyspneia variation (Borg scale)
timeFrame: 7 days
measure: Respiratory frequency variation
timeFrame: 7 days
measure: oxygen saturation/fraction of inspired oxygen (SpO2/FiO2) variation
timeFrame: 7 days
measure: Carbon dioxide arterial partial pressure (PaCO2) variation
timeFrame: 7 days
Other outcomes:
measure: Comfort visual analog scale variation
timeFrame: 7 days
measure: Endotracheal intubation (ETI) rate
timeFrame: 7 days
measure: Mortality
timeFrame: 28 days
measure: Mortality
timeFrame: 90 days
Locations:
city: Brasília
country: Brazil
facility: Hospital de Brasilia (HOBRA)
state: DF
city: Vitória
country: Brazil
facility: Hospital UNIMED Vitória
state: ES
city: São Paulo
country: Brazil
facility: Instituto de Cardiologia Dante Pazanese
state: Sao Paulo
city: Florianópolis
country: Brazil
facility: Hospital Nereu Ramos
state: SC
city: Sao Paulo
country: Brazil
facility: Hospital do Coracao
city: Sao Paulo
country: Brazil
facility: InCor - Hospital das Clinicas da Faculdade de Medicina da USP
Study officials:
affiliation: Hospital do Coração
name: Leticia Kawano-Dourado, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital do Coração
name: Israel Maia, MD
role: PRINCIPAL_INVESTIGATOR
References: