Respiratory Failure With HypoxiaHENIVOTpilotNCT04502576

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

A study testing Noninvasive respiratory support in people with Respiratory Failure With Hypoxia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 5 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Respiratory Failure With Hypoxia
What is being tested?: Noninvasive respiratory support
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 5 sitesItaly
Study dates: 13 Oct 2020to 1 Dec 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Italy5 sites

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

Other trials in Italy

About this study

Official title: Helmet Noninvasive Ventilation vs. High-flow Nasal Cannula in Moderate-to-severe Acute Hypoxemic Respiratory Failure: an Open Label, Pilot, Randomized Trial

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.

Conditions: Respiratory Failure With Hypoxia
Being tested: Noninvasive respiratory support

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Noninvasive respiratory supportDevice
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

Study groups in NCT04502576
Study group	Role	What they receive
High-flow nasal cannula	Active comparator	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. Receives: Device: Noninvasive respiratory support
Helmet noninvasive ventilation	Experimental	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. Receives: Device: Noninvasive respiratory support

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 28 days

Secondary outcomes (11)

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
Measured: 28 days
Invasive ventilation-free days within 28 days from randomization
The number of days in which patients did not receive invasive mechanical ventilation
Measured: 28 days
Invasive ventilation-free days within 60 days from randomization
The number of days in which patients did not receive invasive mechanical ventilation
Measured: 60 days
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
Measured: 28 days
Carbon dioxide
PaCO2 will be measured 1, 6, 12, 24 hours after randomization and then once daily up to intensive care unit discharge
Measured: 28 days
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
Measured: 28 days
Respiratory rate
Respiratory rate will be measured 1, 6, 12, 24 hours after randomization and then once daily up to intensive care unit discharge
Measured: 28 days
In-intensive care unit mortality
Clinical outcome (dead/alive) at intensive care unit discharge
Measured: 90 days
In-hospital mortality
Clinical outcome (dead/alive) at hospital discharge
Measured: 90 days
90-day mortality
Clinical outcome (dead/alive) at 90 days after randomization
Measured: 90 days
Quality of life after recovery
Quality of life in survivors, assessed by Short Form-36 questionnaire
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Oct 20201 Dec 2022

First posted6 Aug 2020
Study start13 Oct 2020
Primary completion10 Jan 2021
Study completion1 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Respiratory Failure With HypoxiaStudies of the same condition, open and under way.
More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04502576
Sponsor's protocol ID: 4443
Acronym: HENIVOTpilot
Status last verified: Oct 2021
First submitted: 3 Aug 2020
Last updated: 3 Jan 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Data will be made available upon a reasonable request

Publications

Michi T, Mattana C, Menga LS, Bocci MG, Cesarano M, Rosa T, Gualano MR, Montomoli J, Spadaro S, Tosato M, Rota E, Landi F, Cutuli SL, Tanzarella ES, Pintaudi G, Piervincenzi E, Bello G, Tonetti T, Rucci P, De Pascale G, Maggiore SM, Grieco DL, Conti G, Antonelli M; Gemelli COVID-ICU study group. Long-term outcome of COVID-19 patients treated with helmet noninvasive ventilation vs. high-flow nasal oxygen: a randomized trial. J Intensive Care. 2023 May 19;11(1):21. doi: 10.1186/s40560-023-00669-0.
PubMed 37208787
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.
PubMed 33764378

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Respiratory Failure, Hypoxemia
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Recruiting
Identifying the Best Flow Setting Strategy for High-Flow Nasal Cannula
Extubation Readiness, Respiratory Failure With Hypoxia
Recruiting
Effects of Oxygen Supplementation During the 6-Minute Walk Test in Chronic Respiratory Failure or Exertional Hypoxemia
Chronic Respiratory Failure, Hypoxemia
Active, not recruiting
Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure: Application to the COVID-19 Pandemic
SARS-CoV-2 Infections, Respiratory Failure With Hypoxia

All Respiratory Failure With Hypoxia trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Helmet Noninvasive Ventilation vs. High-flow Nasal Cannula in Moderate-to-severe Acute Hypoxemic Respiratory Failure: an Open Label, Pilot, Randomized Trial
ClinicalTrials.gov ID: NCT04502576
Acronym / sponsor ID: HENIVOTpilot / 4443
Conditions: Respiratory Failure With Hypoxia
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
Collaborators: Università degli studi di Chieti, Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
Study start: 13 Oct 2020 (actual)
Primary completion: 10 Jan 2021 (actual)
Study completion: 1 Dec 2022 (actual)
First posted: 6 Aug 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
High-flow nasal cannula	Active comparator	Device: Noninvasive respiratory supportHigh-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.
Helmet noninvasive ventilation	Experimental	Device: Noninvasive respiratory supportPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Noninvasive respiratory supportIn 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	Device	Helmet noninvasive ventilation, High-flow nasal cannula

Primary outcome

Respiratory-support free days within 28 days from randomization
Time frame: 28 days
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)

11 secondary outcomes

Endotracheal intubation
Time frame: 28 days
Invasive ventilation-free days within 28 days from randomization
Time frame: 28 days
Invasive ventilation-free days within 60 days from randomization
Time frame: 60 days
Oxygenation
Time frame: 28 days
Carbon dioxide
Time frame: 28 days
Dyspnea
Time frame: 28 days
Respiratory rate
Time frame: 28 days
In-intensive care unit mortality
Time frame: 90 days
In-hospital mortality
Time frame: 90 days
90-day mortality
Time frame: 90 days
Quality of life after recovery
Time frame: 1 year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
Derived from this study: PubMed 37208787Michi T, Mattana C, Menga LS, Bocci MG, Cesarano M, Rosa T, Gualano MR, Montomoli J, Spadaro S, Tosato M, Rota E, Landi F, Cutuli SL, Tanzarella ES, Pintaudi G, Piervincenzi E, Bello G, Tonetti T, Rucci P, De Pascale G, Maggiore SM, Grieco DL, Conti G, Antonelli M; Gemelli COVID-ICU study group. Long-term outcome of COVID-19 patients treated with helmet noninvasive ventilation vs. high-flow nasal oxygen: a randomized trial. J Intensive Care. 2023 May 19;11(1):21. doi: 10.1186/s40560-023-00669-0.
Derived from this study: PubMed 33764378Grieco 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.
Individual participant dataSharing planned: Undecided. Data will be made available upon a reasonable request

Related trials for Respiratory Failure With Hypoxia

RecruitingObservational study
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Respiratory Failure, Hypoxemia
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Recruiting
Identifying the Best Flow Setting Strategy for High-Flow Nasal Cannula
Extubation Readiness, Respiratory Failure With Hypoxia
Recruiting
Effects of Oxygen Supplementation During the 6-Minute Walk Test in Chronic Respiratory Failure or Exertional Hypoxemia
Chronic Respiratory Failure, Hypoxemia
Active, not recruiting
Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure: Application to the COVID-19 Pandemic
SARS-CoV-2 Infections, Respiratory Failure With Hypoxia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Domenico Luca Grieco, MD principal investigator

Fondazione Policlinico A. Gemelli IRCCS

Massimo Antonelli, MD study director

Fondazione Policlinico A. Gemelli IRCCS

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Noninvasive respiratory support in people with Respiratory Failure With Hypoxia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 5 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Respiratory-support free days within 28 days from randomization (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04502576, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.