Back to resultsHelmet NIV vs. CPAP vs. High-flow Nasal Oxygen in Hypoxemic Respiratory Failure (HENIVOT2)
Primary Purpose
Respiratory Failure, Hypoxemic Respiratory Failure
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Noninvasive respiratory support
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Failure focused on measuring Noninvasive ventilation, High-flow nasal oxygen, Mechanical ventilation
Eligibility Criteria
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.
Sites / Locations
- GemelliRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Helmet Noninvasive ventilation (NIV)
Helmet continuous airway pressure (CPAP)
High-flow nasal oxygen
Arm Description
Patients in helmet noninvasive ventilation group will receive continuous helmet pressure support ventilation for at least 16 hours/day in the first 2 calendar days. Dedicated helmets for noninvasive ventilation will be applied and size will be chosen according to patient's neck circumference. Each patient will be connected to a mechanical ventilator ventilator through a bitube circuit with no humidification. The ventilator will be set in PSV-NIV mode, with the following suggested settings [34-38]: initial pressure support=12 cmH2O and adequate to permit a peak inspiratory flow of 100 l/min; positive end-expiratory pressure=12 cmH2O. FiO2 will be titrated to obtain an SpO2≥92% and ≤98%. Inspiratory flow trigger = 2 l/min or according to the practice of each institution; fastest pressurization time; expiratory trigger: 10-50% of the maximum inspiratory flow, eventually modified to avoid double triggering; maximum inspiratory time 1.2 second.
Patients in CPAP group will receive continuous helmet CPAP for at least 16 hours/day in the first 2 calendar days. Continuous CPAP without interruptions will be strongly encouraged in the first 48 hours of treatment. Dedicated helmets for noninvasive ventilation will be applied and size will be chosen according to patient's neck circumference. Treatment will be delivered through a high-flow generator. The following settings will be applied: Continuous air flow>45 l/min. Bi-tube circuit with no humidification, Y-piece with heat and moisture exchanger, or active heating and humidification with humidification chamber temperature set at 31 °C, 34 °C or 37 °C according to patients' comfort. Expiratory positive end-expiratory pressure valve set to achieve PEEP=12 cmH2O. FiO2 will be titrated to obtain an SpO2≥92% and ≤98%.
Initial set flow will be 50-60 l/min and flows will be decreased. in case of intolerance and/or according to patients' requirements: flows≥30 L/min will be mandatory in all enrolled patients. Humidification chamber will be set at 31 °C, 34 °C or 37 °C according to patient's comfort. FiO2 will be titrated to obtain an SpO2≥92% and ≤98%. Weaning the patient from high-flow will be considered only after 48 hours from enrolment and will be discouraged until the patients is considered for ICU discharge.
Outcomes
Primary Outcome Measures
Rate of Endotracheal intubation
The proportion of patients requiring endotracheal intubation according to predefined criteria
Secondary Outcome Measures
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
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
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
Rate of In-intensive care unit mortality
All-cause mortality, assessed at the discharge from the intensive care unit
Rate of In-hospital care unit mortality
All-cause mortality, assessed at the discharge from the hospital
Rate of 90-day mortality
All-cause 90-day mortality
90-day ICU free days
The days not spent in the intensive care unit by the patient on a 90-day basis
90-day hospital free days
The days not spent in the hospital by the patient on a 90-day basis
Incidence of pneumonia
Incidence of pneumonia, diagnosed after the treatment start and during the ICU stay
Incidence of shock
Incidence of shock, diagnosed after treatment start and during the ICU stay
Incidence of barotrauma
Incidence of barotrauma, defined as pneumothorax o pneumomediastinum after treatment start and during the ICU stay
Full Information
NCT ID
NCT05089695
First Posted
October 11, 2021
Last Updated
April 27, 2022
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators
Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva, Catholic University of the Sacred Heart
1. Study Identification
Unique Protocol Identification Number
NCT05089695
Brief Title
Helmet NIV vs. CPAP vs. High-flow Nasal Oxygen in Hypoxemic Respiratory Failure
Acronym
HENIVOT2
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators
Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva, Catholic University of the Sacred Heart
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Detailed Description
The optimal initial management of acute hypoxemic respiratory failure is uncertain. Helmet noninvasive ventilation and high-flow nasal oxygen appear as the most promising techniques in this setting. Recently, the first head-to-head randomized trial compared first-line continuous treatment with helmet pressure support ventilation with specific settings (PEEP=12 cmH2O pressure and pressure support=10-12 cmH2O) vs. high-flow nasal oxygen alone in patients with moderate-to-severe hypoxemic respiratory failure. Results showed no significant inter-group difference in the days free of respiratory support at 28 days, but lower intubation rate and increased 28-day invasive ventilation-free days in the helmet group. Use of helmet noninvasive ventilation is less frequent than use of helmet continuous positive airway pressure, which is simpler to use.
The investigators designed an open-label, multicentre randomized trial to assess the effect of helmet pressure support ventilation and continuous airway pressure as compared to high-flow nasal oxygen on the intubation rate of patients with moderate-to-severe hypoxemic respiratory failure in the intensive care unit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Hypoxemic Respiratory Failure
Keywords
Noninvasive ventilation, High-flow nasal oxygen, Mechanical ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Helmet Noninvasive ventilation (NIV)
Arm Type
Experimental
Arm Description
Patients in helmet noninvasive ventilation group will receive continuous helmet pressure support ventilation for at least 16 hours/day in the first 2 calendar days. Dedicated helmets for noninvasive ventilation will be applied and size will be chosen according to patient's neck circumference.
Each patient will be connected to a mechanical ventilator ventilator through a bitube circuit with no humidification.
The ventilator will be set in PSV-NIV mode, with the following suggested settings [34-38]:
initial pressure support=12 cmH2O and adequate to permit a peak inspiratory flow of 100 l/min;
positive end-expiratory pressure=12 cmH2O.
FiO2 will be titrated to obtain an SpO2≥92% and ≤98%.
Inspiratory flow trigger = 2 l/min or according to the practice of each institution;
fastest pressurization time;
expiratory trigger: 10-50% of the maximum inspiratory flow, eventually modified to avoid double triggering;
maximum inspiratory time 1.2 second.
Arm Title
Helmet continuous airway pressure (CPAP)
Arm Type
Experimental
Arm Description
Patients in CPAP group will receive continuous helmet CPAP for at least 16 hours/day in the first 2 calendar days. Continuous CPAP without interruptions will be strongly encouraged in the first 48 hours of treatment. Dedicated helmets for noninvasive ventilation will be applied and size will be chosen according to patient's neck circumference.
Treatment will be delivered through a high-flow generator. The following settings will be applied:
Continuous air flow>45 l/min.
Bi-tube circuit with no humidification, Y-piece with heat and moisture exchanger, or active heating and humidification with humidification chamber temperature set at 31 °C, 34 °C or 37 °C according to patients' comfort.
Expiratory positive end-expiratory pressure valve set to achieve PEEP=12 cmH2O.
FiO2 will be titrated to obtain an SpO2≥92% and ≤98%.
Arm Title
High-flow nasal oxygen
Arm Type
Active Comparator
Arm Description
Initial set flow will be 50-60 l/min and flows will be decreased. in case of intolerance and/or according to patients' requirements: flows≥30 L/min will be mandatory in all enrolled patients. Humidification chamber will be set at 31 °C, 34 °C or 37 °C according to patient's comfort. FiO2 will be titrated to obtain an SpO2≥92% and ≤98%.
Weaning the patient from high-flow will be considered only after 48 hours from enrolment and will be discouraged until the patients is considered for ICU discharge.
Intervention Type
Device
Intervention Name(s)
Noninvasive respiratory support
Intervention Description
Treatment of acute hypoxemic respiratory failure
Primary Outcome Measure Information:
Title
Rate of Endotracheal intubation
Description
The proportion of patients requiring endotracheal intubation according to predefined criteria
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Days free of invasive mechanical ventilation at day 28
Description
The number of days in which patients do not receive mechanical ventilation within 28 days from randomization
Time Frame
28 days
Title
Days free of invasive mechanical ventilation at day 60
Description
The number of days in which patients do not receive mechanical ventilation within 60 days from randomization
Time Frame
60 days
Title
Days free of invasive mechanical ventilation at day 90
Description
The number of days in which patients do not receive mechanical ventilation within 60 days from randomization
Time Frame
90 days
Title
Rate of In-intensive care unit mortality
Description
All-cause mortality, assessed at the discharge from the intensive care unit
Time Frame
90 days
Title
Rate of In-hospital care unit mortality
Description
All-cause mortality, assessed at the discharge from the hospital
Time Frame
90 days
Title
Rate of 90-day mortality
Description
All-cause 90-day mortality
Time Frame
90 days
Title
90-day ICU free days
Description
The days not spent in the intensive care unit by the patient on a 90-day basis
Time Frame
90 days
Title
90-day hospital free days
Description
The days not spent in the hospital by the patient on a 90-day basis
Time Frame
90 days
Title
Incidence of pneumonia
Description
Incidence of pneumonia, diagnosed after the treatment start and during the ICU stay
Time Frame
90 days
Title
Incidence of shock
Description
Incidence of shock, diagnosed after treatment start and during the ICU stay
Time Frame
90 days
Title
Incidence of barotrauma
Description
Incidence of barotrauma, defined as pneumothorax o pneumomediastinum after treatment start and during the ICU stay
Time Frame
90 days
Other Pre-specified Outcome Measures:
Title
Safety endpoint-causes of endotracheal intubation
Description
Among patients meeting the primary endpoint, the cause of noninvasive treatment failure (as defined by the predefined intubation criteria)
Time Frame
28 days
Title
Safety endpoint-time to treatment failure
Description
In patients meeting the primary endpoint, the time (hours) from randomization to intubation
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Domenico Luca Grieco, MD
Phone
+393397681623
Email
dlgrieco@outlook.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Domenico Luca Grieco, MD
Organizational Affiliation
Fondazione Policlinico A. Gemelli IRCCS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Massimo Antonelli, MD
Organizational Affiliation
Fondazione Policlinico A. Gemelli IRCCS
Official's Role
Study Chair
Facility Information:
Facility Name
Gemelli
City
Rome
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Domenico L Grieco, MD
Email
dlgrieco@outlook.it
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual data will be made available by the principal investigator upon a reasonable request
IPD Sharing Time Frame
With publication the results
IPD Sharing Access Criteria
Individual data will be made available by the principal investigator upon a reasonable request
Learn more about this trial
Helmet NIV vs. CPAP vs. High-flow Nasal Oxygen in Hypoxemic Respiratory Failure
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