High-Flow Nasal Oxygen Cannula Compared to Non-Invasive Ventilation in Adult Patients With AcuTE Respiratory Failure

NCT03643939 | Completed DMC

• 1 other identifier: RENOVATEmain_2018_08
• Study Type: interventional
• Target: 1,801
• Locations: 1 country
• Sites: 1

Brief Summary

RENOVATE study aims to investigate if the respiratory support device called High-Flow Nasal Oxygen Cannula (HFNC) acts similarly (non-inferior) to another respiratory support device called Non-Invasive positive-pressure Ventilation (NIPPV) in preventing endotracheal intubation in adult patients with Acute Respiratory Failure (ARF) from different causes. HFNC is a somewhat new method of respiratory support in adults that has been used in neonatal ARF for some years. The reason this study is necessary is that, even though NIPPV has been demonstrated to prevent endotracheal intubation (and its associated complications) in a broad range of ARF patients, HFNC has been proposed to have the same beneficial effect of NIPPV while being easier tolerated, allowing patients to talk, eat and drink through mouth while on HFNC. RENOVATE will recruit between 800 to 2000 patients (adaptive design) with different types of ARF in Brazil. Patients will be randomized to HFNC or NIPPV and the rate of endotracheal intubation will be compared between groups as well as other parameters such as vital status and other health care related complications. \[IMPORTANT NOTE\] On April 13, 2021, on the first interim analysis, the DSMB recommended the interruption of the immunocompromised hypoxemic ARF subgroup.

Conditions

Respiratory Insufficiency; Respiratory Failure

Keywords

respiratory insufficiency; respiratory failure; non-invasive ventilation; high flow nasal cannula; nasal high flow; trans-nasal insufflation; NIV; HFNC

Outcome Measures

Primary Outcomes (1)

• Endotracheal intubation rate or death

  proportion of endotracheal intubation or death

  in 7 days

Secondary Outcomes (4)

• Mortality

  in 28 days

• Mortality

  in 90 days

• ICU free days

  in 28 days

• IMV free days

  in 28 days

Other Outcomes (5)

• Length of hospital stay

  in 90 days

• Length of ICU stay

  in 90 days

• Vasopressor free days

  in 28 days

Study Arms (2)

High Flow Nasal Catheter

EXPERIMENTAL

The HFNC (AIRVO2 Fisher \& Paykel, Auckland, New Zealand) consists of an apparatus that allows adjustable FiO2 from 21 to 100% and delivers flow up to 60 L/ min.

Device: High Flow Nasal Catheter

Non-invasive positive pressure ventilation

ACTIVE COMPARATOR

NIPPV will be performed using the devices available on centers. Both a dedicated NIPPV device or invasive mechanical ventilator with NIPPV mode are accepted. The interface should be a oronasal or full face mask.

Device: Noninvasive ventilation

Interventions

High Flow Nasal Catheter DEVICE

HFNC will deliver 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 patient´s comfort and SpO2.

Also known as: Optiflow, Airvo, trans-nasal insufflation, Nasal High Flow, High Flow Nasal Cannula, nasal cannula with high-flow oxygen

High Flow Nasal Catheter

Noninvasive ventilation DEVICE

NIPPV will be performed using a facial mask (either oronasal or full face). NIPPV will deliver pressures and FiO2 tailored to specific ARF subgroups, according to the protocol. Adjustments of the inspiratory pressure (IPAP) and expiratory pressure (EPAP) and FiO2 according to protocol

Also known as: BiPAP, Non-invasive ventilation, Noninvasive positive pressure ventilation

Non-invasive positive pressure ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must meet criteria 1, 2 and 3:
• Hypoxemia evidenced by SpO2 \<90% or PaO2 \<60 mmHg in room air
• Use of accessory muscles, paradoxical breathing, and/or thoracoabdominal asynchrony
• RR\> 25 per minute
• Patients must meet criteria 1, 2, 3 and 4:
• Immunosuppression diagnosis:
• i. Use of Immunosuppressive drug or long-term \[\>3 months\] or high-dose \[\>0.5 mg/kg/day\] steroids ii. Solid organ transplantation iii. Extensive solid tumor or solid tumor requiring chemotherapy in the last 5 years iv. Hematological malignancy regardless of time since diagnosis and received treatments v. HIV infection vi. Primary immunodefiency
• Hypoxemia evidenced by SpO2 \<90% or PaO2 \<60 mmHg in room air
• Use of accessory muscles, paradoxical breathing, and/or thoracoabdominal asynchrony
• RR\> 25 per minute
• Patients must meet criteria 1 or 2 and 3 and 4:
• Previous Diagnosis of COPD based on GOLD guidelines
• Strong clinical suspicion of COPD i. Smoker or ex-smoker or other CPOD related exposure ii. Presence of chronic dyspnea on exertion or chronic productive cough iii. Excluded other causes for the chronic symptoms (ex. pulmonary fibrosis, heart failure)
• RR\> 25 per minute or use of accessory muscles, paradoxical breathing, and/or thoracoabdominal asynchrony
• ABG analysis with pH \< 7,35 , paCO2\> 45 mmHg

You may not qualify if:

• Indication of emergency ETI:
• Prolonged respiratory pauses
• Cardiorespiratory arrest
• Glasgow ≤12
• HR \< 50 bpm with decreased level of consciousness
• pH \< 7.15 irrespective of the cause
• Psychomotor agitation that prevents adequate medical / nursing care requiring heavy sedation
• Persistent hemodynamic instability with MAP \<65 mmHg, SBP \<90 mmHg after adequate volume resuscitation or requiring norepinephrine\> 0.3 microg / kg / min or equivalent.
• Contraindications to non-invasive ventilation: face deformities or traumas, recent esophageal surgery, hypersecretion, vomiting with aspiration risk
• Presence of pneumothorax or extensive pleural effusion
• Severe arrhythmias at risk of hemodynamic instability
• Thoracic trauma understood as the main cause of ARF
• Asthma attack
• Pregnancy
• Cardiogenic Shock

Sponsors & Collaborators

• Hospital do Coracao: lead
• Ministry of Health, Brazil: collaborator
• Berry Consultants: collaborator

Study Sites (1)

Hospital do Coracao

São Paulo, 05435000, Brazil

Location

Related Publications (2)

• RENOVATE Investigators and the BRICNet Authors; Maia IS, Kawano-Dourado L, Tramujas L, de Oliveira NE, Souza RN, Signorini DF, Pincelli MP, Zandonai CL, Blasius RT, Freires F, Ferreira VM, Romano MLP, Miura MC, de Censo CM, Caser EB, Silva B, Santos Bonomo DC, Arraes JA, de Alencar Filho MS, Alvares Horta JG, Oliveira DC, Boschi E, Costa RL, Westphal GA, Ramos J, Lacerda FH, Filho CRH, Pinheiro BV, de Andrade Neumamm LB, Guimaraes Junior MRR, de Souza DT, Ferreira JC, Ohe LN, Schettini DA, Thompson MM, de Oliveira MCF, Veiga VC, Negrelli KL, Santos RHN, Damiani L, Gurgel RM, Gomes SPC, Lima LM, Miranda TA, Laranjeira LN, de Barros E Silva PGM, Machado FR, Fitzgerald M, Bosse A, Marion J, Carvalho CRR, Brochard L, Lewis RJ, Biasi Cavalcanti A. High-Flow Nasal Oxygen vs Noninvasive Ventilation in Patients With Acute Respiratory Failure: The RENOVATE Randomized Clinical Trial. JAMA. 2025 Mar 11;333(10):875-890. doi: 10.1001/jama.2024.26244.

  PMID: 39657981 DERIVED

• Maia IS, Kawano-Dourado L, Zampieri FG, Damiani LP, Nakagawa RH, Gurgel RM, Negrelli K, Gomes SPC, Paisani D, Lima LM, Santucci EV, Valeis N, Laranjeira LN, Lewis R, Fitzgerald M, Carvalho CRR, Brochard L, Cavalcanti AB; RENOVATE Investigators and the BRICNet. High flow nasal catheter therapy versus non-invasive positive pressure ventilation in acute respiratory failure (RENOVATE trial): protocol and statistical analysis plan. Crit Care Resusc. 2023 Oct 18;24(1):61-70. doi: 10.51893/2022.1.OA8. eCollection 2022 Mar 7.

  PMID: 38046839 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Cannula; Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Alexandre B Cavalcanti, MD

  Research Institute - Hospital do Coracao, Sao Paulo, Brazil

  STUDY CHAIR

• Israel Maia, MD

  Research Institute - Hospital do Coracao, Sao Paulo, Brazil

  PRINCIPAL INVESTIGATOR

• Leticia Kawano-Dourado, MD

  Research Institute - Hospital do Coracao, Sao Paulo, Brazil

  PRINCIPAL INVESTIGATOR

• Laurent Brochard, MD

  St. Michael's Hospital (Toronto, Canada)

  STUDY CHAIR

• Carlos R Carvalho, MD

  Pulmonary Division University of Sao Paulo, Sao Paulo, Brazil

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adaptive, non-inferiority randomized, open-label, controled clinical trial

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 23, 2018
• Study Start: November 1, 2019
• Primary Completion: November 30, 2023
• Study Completion: February 28, 2024
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)