Respiratory Failure Clinical Trial
— HENIVOT2Official title:
Helmet Noninvasive Ventilation vs. Continuous Positive Airway Pressure vs. High-flow Nasal Oxygen as First-line Treatment of Acute Hypoxemic Respiratory Failure (HENIVOT2). An Open-label, Multicentre Randomized Trial
NCT number | NCT05089695 |
Other study ID # | HENIVOT2 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2022 |
Est. completion date | June 2026 |
Multicenter, open label, three-arm randomized trial to assess the effect of helmet noninvasive ventilation vs. helmet continuous positive airway pressure vs. high-flow nasal oxygen on the rate of endotracheal intubation of patients with acute moderate-to-severe hypoxemic respiratory failure
Status | Recruiting |
Enrollment | 1200 |
Est. completion date | June 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Acute symptoms of respiratory failure PaO2/FiO2 ratio = 200; PaCO2=45mmHg; Absence of history of chronic respiratory failure or moderate to severe cardiac insufficiency (NYHA>2 or left ventricular ejection fraction<50%); Informed consent Patients that have already received NIV, CPAP continuously for more than 24 hours before the screening visit will be excluded. Other Exclusion Criteria: - Pregnancy; - Exacerbation of asthma or chronic obstructive pulmonary disease; - Hypercapnia (PaCO2>45 mmHg) with or without respiratory acidosis; - More than 2 organ failures, including the lung. - Documented pneumothorax; - Clinical diagnosis of Cardiogenic pulmonary edema; - Haemodynamic instability (Systolic blood pressure<90 mmHg or mean arterial pressure<65mmHg) and/or lactic acidosis (lactate>5 mmol/L) and/or clinically diagnosed Shock requiring administration of vasoactive agents (norepinephrine>0.1 mcg/Kg/min); - Metabolic Acidosis (pH <7.30 with normal- or hypo-carbia); - Chronic kidney failure requiring dialysis before ICU admission; - Chronic hypoxemic respiratory failure requiring long-term oxygen therapy; - Altered neurological status that requires immediate intubation and/or making the patient uncooperative; - Urgent need for endotracheal intubation, according to the decision of the attending physician; - Do not intubate order; - Decision of withdrawal of life-sustaining therapy; - Thoracic or abdominal surgery in the previous 7 days; - Any condition that makes the patient very likely to require endotracheal intubation due to a reason different from respiratory failure; - Recent head surgery or anatomy that prevent the application of helmet or HFNC to patient's face. |
Country | Name | City | State |
---|---|---|---|
Italy | Gemelli | Rome |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Catholic University of the Sacred Heart, Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety endpoint-causes of endotracheal intubation | Among patients meeting the primary endpoint, the cause of noninvasive treatment failure (as defined by the predefined intubation criteria) | 28 days | |
Other | Safety endpoint-time to treatment failure | In patients meeting the primary endpoint, the time (hours) from randomization to intubation | 28 days | |
Primary | Rate of Endotracheal intubation | The proportion of patients requiring endotracheal intubation according to predefined criteria | 28 days | |
Secondary | Days free of invasive mechanical ventilation at day 28 | The number of days in which patients do not receive mechanical ventilation within 28 days from randomization | 28 days | |
Secondary | Days free of invasive mechanical ventilation at day 60 | The number of days in which patients do not receive mechanical ventilation within 60 days from randomization | 60 days | |
Secondary | Days free of invasive mechanical ventilation at day 90 | The number of days in which patients do not receive mechanical ventilation within 60 days from randomization | 90 days | |
Secondary | Rate of In-intensive care unit mortality | All-cause mortality, assessed at the discharge from the intensive care unit | 90 days | |
Secondary | Rate of In-hospital care unit mortality | All-cause mortality, assessed at the discharge from the hospital | 90 days | |
Secondary | Rate of 90-day mortality | All-cause 90-day mortality | 90 days | |
Secondary | 90-day ICU free days | The days not spent in the intensive care unit by the patient on a 90-day basis | 90 days | |
Secondary | 90-day hospital free days | The days not spent in the hospital by the patient on a 90-day basis | 90 days | |
Secondary | Incidence of pneumonia | Incidence of pneumonia, diagnosed after the treatment start and during the ICU stay | 90 days | |
Secondary | Incidence of shock | Incidence of shock, diagnosed after treatment start and during the ICU stay | 90 days | |
Secondary | Incidence of barotrauma | Incidence of barotrauma, defined as pneumothorax o pneumomediastinum after treatment start and during the ICU stay | 90 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03909854 -
Pragmatic Investigation of Volume Targeted Ventilation-1
|
N/A | |
Recruiting |
NCT03662438 -
HOPE (Home-based Oxygen [Portable] and Exercise) for Patients on Long Term Oxygen Therapy (LTOT)
|
N/A | |
Recruiting |
NCT05308719 -
Nasal Oxygen Therapy After Cardiac Surgery
|
N/A | |
Recruiting |
NCT05535543 -
Change in the Phase III Slope of the Volumetric Capnography by Prone Positioning in Acute Respiratory Distress Syndrome
|
||
Completed |
NCT04030208 -
Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation
|
N/A | |
Recruiting |
NCT04542096 -
Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
|
||
Recruiting |
NCT04668313 -
COVID-19 Advanced Respiratory Physiology (CARP) Study
|
||
Recruiting |
NCT05883137 -
High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
|
||
Completed |
NCT04505592 -
Tenecteplase in Patients With COVID-19
|
Phase 2 | |
Completed |
NCT03943914 -
Early Non-invasive Ventilation and High-flow Nasal Oxygen Therapy for Preventing Delayed Respiratory Failure in Hypoxemic Blunt Chest Trauma Patients.
|
N/A | |
Active, not recruiting |
NCT03472768 -
The Impact of Age-dependent Haptoglobin Deficiency on Plasma Free Hemoglobin Levels During Extracorporeal Membrane Oxygenation Support
|
||
Not yet recruiting |
NCT04538469 -
Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
|
||
Not yet recruiting |
NCT02542423 -
Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure.
|
N/A | |
Completed |
NCT02265198 -
Relationship of Pulmonary Contusion to Pulmonary Inflammation and Incidence of Acute Respiratory Distress Syndrome
|
N/A | |
Completed |
NCT02105298 -
Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)
|
N/A | |
Completed |
NCT01885442 -
TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients
|
N/A | |
Completed |
NCT02814994 -
Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients
|
N/A | |
Completed |
NCT01659268 -
Performance of Baccalaureate Nursing Students in Insertion of Laryngeal Mask: a Trial in Mannequins
|
N/A | |
Completed |
NCT01204281 -
Proportional Assist Ventilation (PAV) in Early Stage of Critically Ill Patients
|
Phase 4 | |
Terminated |
NCT01333059 -
Cycling of Sedative Infusions in Critically Ill Pediatric Patients
|
N/A |