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Helmet Noninvasive Ventilation vs. High-flow Nasal Cannula in Moderate-to-severe Acute Hypoxemic Respiratory Failure (HENIVOTpilot)

Primary Purpose

Respiratory Failure With Hypoxia

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Noninvasive respiratory support
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure With Hypoxia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Acute-onset respiratory distress or flue-related symptoms Moderate-to-severe hypoxemia (PaO2/FiO2<=200 mmHg) PaCO2<45 mmHg pH>7.30

Exclusion Criteria:

Need for urgent endo-tracheal intubation Exacerbation of asthma or chronic obstructive pulmonary disease Documented pneumothorax Clinical diagnosis of Cardiogenic pulmonary oedema Do-not-intubate order Altered neurological status that requires immediate intubation and/or making the patient uncooperative Thoracic or abdominal surgery in the previous 7 days Recent head surgery or anatomy that prevent the application of helmet or Optiflow to patient's face

Sites / Locations

  • Policlinico di Sant'Orsola, Alma Mater Studiorum-Università di Bologna
  • SS. Annunziata Hospital, Gabriele d'Annunzio University of Chieti-Pescara
  • Azienda Ospedaliera-Universitaria Arcispedale Sant'Anna, University of Ferrara
  • Infermi Hospital
  • Fondazione Policlinico Universitaro A. Gemelli IRCCS

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

High-flow nasal cannula

Helmet noninvasive ventilation

Arm Description

High-flow nasal cannula will be delivered with the Optiflow system. Initial set flow will be ≥ 50 /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 (MR860, Fisher and Paykel healthcare, New Zealand) will be set at 37 °C or 34 °C according to patient's comfort. FiO2 will be titrated to obtain an SpO2≥92% and ≤98%. The treatment according to the assigned protocol will be continued until the patient requires endotracheal intubation or (in case of no intubation) up to ICU discharge. Weaning from high-flow will be considered as standardized criteria are met.

Patients will receive continuous helmet pressure support ventilation for at least 16 hours/day the first 2 calendar days. Continuous noninvasive ventilation without interruptions will be strongly encouraged in the first 24 hours of treatment. The ventilator will be set in pressure support mode. Use of continuous positive airway pressure by flow generators and Venturi systems instead of pressure support ventilation will be allowed in case of shortage of ventilators. Maintenance of positive end-expiratory pressure ≥ 8-10 during the treatment is mandatory. After weaning and during any interruption from noninvasive ventilation, patients will undergo low-flow or high-flow oxygen, according to the decision of the attending physician. The treatment according to the assigned protocol will be continued until the patient requires endotracheal intubation or (in case of no intubation) up to ICU discharge.

Outcomes

Primary Outcome Measures

Respiratory-support free days within 28 days from randomization
The number of days in which patients did not receive any form of respiratory support (i.e. high-flow nasal cannula, noninvasive ventilation, invasive mechanical ventilation)

Secondary Outcome Measures

Endotracheal intubation
The proportion of patients requiring endotracheal intubation in the two groups. The need for endotracheal intubation will be established with predefined criteria, which will be evaluated a posteriori by an independent adjudication committee
Invasive ventilation-free days within 28 days from randomization
The number of days in which patients did not receive invasive mechanical ventilation
Invasive ventilation-free days within 60 days from randomization
The number of days in which patients did not receive invasive mechanical ventilation
Oxygenation
The ratio of PaO2 to FiO2 will be measured 1, 6, 12, 24 hours after randomization and then once daily up to intensive care unit discharge
Carbon dioxide
PaCO2 will be measured 1, 6, 12, 24 hours after randomization and then once daily up to intensive care unit discharge
Dyspnea
Dyspnea will be evaluated through a visual analog scale (0-10, where 10 represents the most sever symptom) will be measured 1, 6, 12, 24 hours after randomization and then once daily up to intensive care unit discharge
Respiratory rate
Respiratory rate will be measured 1, 6, 12, 24 hours after randomization and then once daily up to intensive care unit discharge
In-intensive care unit mortality
Clinical outcome (dead/alive) at intensive care unit discharge
In-hospital mortality
Clinical outcome (dead/alive) at hospital discharge
90-day mortality
Clinical outcome (dead/alive) at 90 days after randomization
Quality of life after recovery
Quality of life in survivors, assessed by Short Form-36 questionnaire

Full Information

First Posted
August 3, 2020
Last Updated
November 18, 2021
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators
Università degli studi di Chieti, Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
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1. Study Identification

Unique Protocol Identification Number
NCT04502576
Brief Title
Helmet Noninvasive Ventilation vs. High-flow Nasal Cannula in Moderate-to-severe Acute Hypoxemic Respiratory Failure
Acronym
HENIVOTpilot
Official Title
Helmet Noninvasive Ventilation vs. High-flow Nasal Cannula in Moderate-to-severe Acute Hypoxemic Respiratory Failure: an Open Label, Pilot, Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
January 10, 2021 (Actual)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators
Università degli studi di Chieti, Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva

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
Helmet noninvasive ventilation and high-flow nasal cannula are novel tools for the first-line treatment of acute hypoxemic respiratory failure. Compared to face-mask noninvasive ventilation in randomized trials, both have improved clinical outcome of patients with moderate-to-severe hypoxemic respiratory failure. As compared to high-flow nasal cannula, helmet noninvasive ventilation improves oxygenation, reduces inspiratory effort, respiratory rate and dyspnea. Whether these physiological benefits are translated into improved outcome remains to be established. The investigators designed a randomized trial to establish whether first line treatment with Helmet noninvasive ventilation is capable of increasing the number of 28-day respiratory-support-free days, as compared to high-flow nasal cannula in patients with moderate-to-severe acute hypoxemic respiratory failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure With Hypoxia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-flow nasal cannula
Arm Type
Active Comparator
Arm Description
High-flow nasal cannula will be delivered with the Optiflow system. Initial set flow will be ≥ 50 /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 (MR860, Fisher and Paykel healthcare, New Zealand) will be set at 37 °C or 34 °C according to patient's comfort. FiO2 will be titrated to obtain an SpO2≥92% and ≤98%. The treatment according to the assigned protocol will be continued until the patient requires endotracheal intubation or (in case of no intubation) up to ICU discharge. Weaning from high-flow will be considered as standardized criteria are met.
Arm Title
Helmet noninvasive ventilation
Arm Type
Experimental
Arm Description
Patients will receive continuous helmet pressure support ventilation for at least 16 hours/day the first 2 calendar days. Continuous noninvasive ventilation without interruptions will be strongly encouraged in the first 24 hours of treatment. The ventilator will be set in pressure support mode. Use of continuous positive airway pressure by flow generators and Venturi systems instead of pressure support ventilation will be allowed in case of shortage of ventilators. Maintenance of positive end-expiratory pressure ≥ 8-10 during the treatment is mandatory. After weaning and during any interruption from noninvasive ventilation, patients will undergo low-flow or high-flow oxygen, according to the decision of the attending physician. The treatment according to the assigned protocol will be continued until the patient requires endotracheal intubation or (in case of no intubation) up to ICU discharge.
Intervention Type
Device
Intervention Name(s)
Noninvasive respiratory support
Intervention Description
In both arms, the treatment according to the assigned protocol will be continued until the patient requires endotracheal intubation or (in case of no intubation) up to ICU discharge. Patients will have to undergo the allocated treatment within 1 hour from the moment of randomization and within 24 hours from admission in the intensive care unit
Primary Outcome Measure Information:
Title
Respiratory-support free days within 28 days from randomization
Description
The number of days in which patients did not receive any form of respiratory support (i.e. high-flow nasal cannula, noninvasive ventilation, invasive mechanical ventilation)
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Endotracheal intubation
Description
The proportion of patients requiring endotracheal intubation in the two groups. The need for endotracheal intubation will be established with predefined criteria, which will be evaluated a posteriori by an independent adjudication committee
Time Frame
28 days
Title
Invasive ventilation-free days within 28 days from randomization
Description
The number of days in which patients did not receive invasive mechanical ventilation
Time Frame
28 days
Title
Invasive ventilation-free days within 60 days from randomization
Description
The number of days in which patients did not receive invasive mechanical ventilation
Time Frame
60 days
Title
Oxygenation
Description
The ratio of PaO2 to FiO2 will be measured 1, 6, 12, 24 hours after randomization and then once daily up to intensive care unit discharge
Time Frame
28 days
Title
Carbon dioxide
Description
PaCO2 will be measured 1, 6, 12, 24 hours after randomization and then once daily up to intensive care unit discharge
Time Frame
28 days
Title
Dyspnea
Description
Dyspnea will be evaluated through a visual analog scale (0-10, where 10 represents the most sever symptom) will be measured 1, 6, 12, 24 hours after randomization and then once daily up to intensive care unit discharge
Time Frame
28 days
Title
Respiratory rate
Description
Respiratory rate will be measured 1, 6, 12, 24 hours after randomization and then once daily up to intensive care unit discharge
Time Frame
28 days
Title
In-intensive care unit mortality
Description
Clinical outcome (dead/alive) at intensive care unit discharge
Time Frame
90 days
Title
In-hospital mortality
Description
Clinical outcome (dead/alive) at hospital discharge
Time Frame
90 days
Title
90-day mortality
Description
Clinical outcome (dead/alive) at 90 days after randomization
Time Frame
90 days
Title
Quality of life after recovery
Description
Quality of life in survivors, assessed by Short Form-36 questionnaire
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute-onset respiratory distress or flue-related symptoms Moderate-to-severe hypoxemia (PaO2/FiO2<=200 mmHg) PaCO2<45 mmHg pH>7.30 Exclusion Criteria: Need for urgent endo-tracheal intubation Exacerbation of asthma or chronic obstructive pulmonary disease Documented pneumothorax Clinical diagnosis of Cardiogenic pulmonary oedema Do-not-intubate order Altered neurological status that requires immediate intubation and/or making the patient uncooperative Thoracic or abdominal surgery in the previous 7 days Recent head surgery or anatomy that prevent the application of helmet or Optiflow to patient's face
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 Director
Facility Information:
Facility Name
Policlinico di Sant'Orsola, Alma Mater Studiorum-Università di Bologna
City
Bologna
Country
Italy
Facility Name
SS. Annunziata Hospital, Gabriele d'Annunzio University of Chieti-Pescara
City
Chieti
Country
Italy
Facility Name
Azienda Ospedaliera-Universitaria Arcispedale Sant'Anna, University of Ferrara
City
Ferrara
Country
Italy
Facility Name
Infermi Hospital
City
Rimini
Country
Italy
Facility Name
Fondazione Policlinico Universitaro A. Gemelli IRCCS
City
Rome
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data will be made available upon a reasonable request
Citations:
PubMed Identifier
33764378
Citation
Grieco DL, Menga LS, Cesarano M, Rosa T, Spadaro S, Bitondo MM, Montomoli J, Falo G, Tonetti T, Cutuli SL, Pintaudi G, Tanzarella ES, Piervincenzi E, Bongiovanni F, Dell'Anna AM, Delle Cese L, Berardi C, Carelli S, Bocci MG, Montini L, Bello G, Natalini D, De Pascale G, Velardo M, Volta CA, Ranieri VM, Conti G, Maggiore SM, Antonelli M; COVID-ICU Gemelli Study Group. Effect of Helmet Noninvasive Ventilation vs High-Flow Nasal Oxygen on Days Free of Respiratory Support in Patients With COVID-19 and Moderate to Severe Hypoxemic Respiratory Failure: The HENIVOT Randomized Clinical Trial. JAMA. 2021 May 4;325(17):1731-1743. doi: 10.1001/jama.2021.4682.
Results Reference
derived

Learn more about this trial

Helmet Noninvasive Ventilation vs. High-flow Nasal Cannula in Moderate-to-severe Acute Hypoxemic Respiratory Failure

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