Acute Respiratory Failure, Pulmonary Fibrosis
Conditions
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.
Interventions
DEVICEHigh 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
NIPPV will be performed using a facial mask (either oronasal or full face). NIPPV will deliver pressures and FiO2 according to the protocol.
Sponsors
Ministry of Health, Brazil
Fisher and Paykel Healthcare
Hospital do Coracao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1:1 randomized controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment feasibility | 18 months | Recruitment of 50 pulmonary fibrosis patients in acute respiratory failure in 18 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory frequency variation | 7 days | Respiratory rate |
| Dyspneia variation (Borg scale) | 7 days | Borg scale |
| oxygen saturation/fraction of inspired oxygen (SpO2/FiO2) variation | 7 days | Oxygen index |
| Carbon dioxide arterial partial pressure (PaCO2) variation | 7 days | CO2 variation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 28 days | Mortality in 28 days |
| Endotracheal intubation (ETI) rate | 7 days | Endotracheal intubation |
| Comfort visual analog scale variation | 7 days | Confort scale |
Countries
Brazil
Outcome results
None listed