Respiratory FailureHIGHFLOWHELMETNCT04241861
High-flow Nasal Cannula vs. Helmet PSV vs. Helmet CPAP During Respiratory Failure
A study testing Respiratory support (High-flow oxygen therapy), Respiratory support (Helmet PSV) and Respiratory support (Helmet CPAP) in people with Respiratory Failure and Hypoxemia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The investigators designed a cross-over, randomized trial to assess the physiological effects of helmet pressure support ventilation (PSV) and continuous positive airway pressure (CPAP) as compared to high-flow nasal cannula during the early phase of acute hypoxemic respiratory failure Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Hypoxemia
- What is being tested?
- Respiratory support (High-flow oxygen therapy), Respiratory support (Helmet PSV) and Respiratory support (Helmet CPAP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 22 Jan 2020to 27 Jan 2021
- 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
- Patients: adult hypoxemic non-hypercapnic patients admitted to the emergency department or the ICU with de novo acute respiratory failure will be assessed for the enrolment.
- Patients will be considered eligible whether all the following inclusion criteria are met:
- Respiratory rate>25 bpm.
- PaO2/FiO2 ≤200 in the supine position, measured after 15 minutes of high flow treatment with face mask (60 l/min, temperature of the humidification chamber set at 37°C, FiO2 set to achieve a SpO2 >92% and <98%). Given the use of the high flows, nominal FiO2 will be considered a reliable estimate of the actual one.
- PaCO2 <45mmHg
- Absence of history of chronic respiratory failure or moderate to severe cardiac insufficiency.
- Written informed consent
Who cannot join
- Exacerbation of asthma or chronic obstructive pulmonary disease;
- Cardiogenic pulmonary oedema;
- Haemodynamic instability (Systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg) and/or lactic acidosis (lactate >5 mmol/L) and/or clinically diagnosed Shock
- Metabolic Acidosis (pH <7.30 with normal- or hypo-carbia);
- Glasgow coma scale <13;
- Recent head surgery or anatomy that prevent the application of helmet or nasal cannula to patient's face.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiological Comparison of High-flow Nasal Cannula, Helmet Pressure Support Ventilation and Continuous Positive Airway Pressure During Acute Hypoxemic Respiratory Failure: a Randomized Cross-over Study
The investigators designed a cross-over, randomized trial to assess the physiological effects of helmet pressure support ventilation (PSV) and continuous positive airway pressure (CPAP) as compared to high-flow nasal cannula during the early phase of acute hypoxemic respiratory failure
Read the detailed description
Setting: 21-bed general ICU, emergency room of the Emergency department (ED), Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS, Rome, Italy..
Patients: adult hypoxemic non-hypercapnic patients admitted to the emergency department or the ICU with de novo acute respiratory failure will be assessed for the enrolment.
Each eligible patient, in the absence of exclusion criteria, will receive 15 minutes of heated and humidified 60% oxygen at a rate of 50 l/min via a non-rebreathing face mask. An ABG will be then collected and PaO2/FiO2 ratio computed: given the high flows used, actual FiO2 will be approximated to the set one.
Nonhypercapnic patients with a PaO2/FiO2≤200 mmHg will be enrolled. In the absence of exclusion criteria and if all other inclusion in criteria are met, patients showing PaO2/FiO2≤300 and >200 mmHg will be treated according to the clinical practice eventually reassessed for the presence of oxygenation criterion subsequently.
Enrolled patients will receive all the interventions (helmet CPAP, PSV and high-flow nasal cannula) in a randomized, cross-over fashion, for 40 minutes each.
At the end of the study, the patient will receive the treatment that will be shown as more appropriate for the patient, according to the attending physician, who will be informed about the results of the study on the individual patient.
- Conditions
- Respiratory Failure, Hypoxemia
- Being tested
- Respiratory support (High-flow oxygen therapy), Respiratory support (Helmet PSV), Respiratory support (Helmet CPAP)
- Medical subject headings
- Respiratory Insufficiency, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory support (High-flow oxygen therapy)Other
Noninvasive respiratory support respiratory support
Respiratory support (Helmet PSV)Other
Noninvasive respiratory support respiratory support
Respiratory support (Helmet CPAP)Other
Noninvasive respiratory support respiratory support
| Study group | Role | What they receive |
|---|---|---|
| High-flow oxygen therapy | Experimental | Nasal high flow oxygen therapy 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 comfort33. FiO2 will be titrated to obtain an SpO2≥92% and ≤98%. Receives: Other: Respiratory support (High-flow oxygen therapy) |
| Helmet PSV | Experimental | Dedicated helmets for noninvasive ventilation will be used and size will be chosen according to neck circumference or according to manufacturer recommendations.
Each patient will be connected to a compressed-gas based ventilator through a bitube circuit with no humidification.
The ventilator will be set in PSV, with the following suggested settings 34-38:
1. initial pressure support≥8-10 cmH2O and adequate to permit of a peak in the inspiratory flow of 100 l/min;
2. positive end-expiratory pressure=10-12 cmH2O and increased to achieve the oxygenation target according to the choice of the attending physician.
3. FiO2 will be titrated to obtain an SpO2≥92% and ≤98%.
4. Inspiratory flow trigger = 1 l/min or according to the practice of each institution;
5. fastest pressurization time;
6. expiratory trigger: 10-50% of the maximum inspiratory flow;
7. maximum inspiratory time 1.2 second. Receives: Other: Respiratory support (Helmet PSV) |
| Helmet CPAP | Experimental | Dedicated helmets for noninvasive ventilation will be uses and size will be chosen according to neck circumference or according to manufacturer recommendations.
Treatment will be delivered through a high-flow generator. The following settings will be applied:
1. Continuous air flow=50-60 L/min.
2. Expiratory positive end-expiratory pressure valve set to achieve a PEEP==10-12 cmH2O and eventually increased to achieve the oxygenation target according to the choice of the attending physician.
3. FiO2 will be titrated to obtain an SpO2≥92% and ≤98%. Pressure inside the helmet will be monitored with a manometer in order to maintain the set PEEP. Receives: Other: Respiratory support (Helmet CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory effort
The negative deflection in esophageal pressure during inspiration
Measured: 40 minutes
Tidal volume
The tidal change in lung impedance, assessed by electrical impedance tomography
Measured: 40 minutes
Secondary outcomes (14)
Oxygenation
Ratio of PaO2 to FiO2
Measured: 40 minutes
Tidal volume distribution
Distribution of tidal volume within the lung regions, assessed by electrical impedance tomography
Measured: 40 minutes
Carbon dioxide
Blood carbon dioxide, measured with the arterial blood gas analysis
Measured: 40 minutes
Respiratory rate
Respiratory rate/minute, assessed with the esophageal pressure
Measured: 40 minutes
Dyspnea
Dyspnea assessed with the visual analog scale, 0-10 scale where the highest value corresponds to the highest degree of dyspnea
Measured: 40 minutes
Comfort
Comfort assessed with the visual analog scale, 0-10 scale where the highest value corresponds to the highest degree of discomfort
Measured: 40 minutes
Global impedance-derived End-expiratory lung volume
End-expiratory lung volume, measured with electrical impedance tomography
Measured: 40 minutes
Regional impedance-derived End-expiratory lung volume
End-expiratory lung impedance in the four regions of the lungs (ventral, mid-ventral, mid-dorsal, dorsal), measured with electrical impedance tomography
Measured: 40 minutes
Dynamic transpulmonary driving pressure
The tidal change in transpulmonary pressure
Measured: 40 minutes
Global impedance-derived lung dynamic strain
Change in impedance due to tidal volume / end expiratory lung impedance, both measured with electrical impedance tomography
Measured: 40 minutes
Regional impedance-derived lung dynamic strain
Change in impedance due to tidal volume / end expiratory lung impedance in the four regions of the lungs (ventral, mid-ventral, mid-dorsal, dorsal), measured with electrical impedance tomography
Measured: 40 minutes
Respiratory system dynamic compliance
Ratio of the tidal change in lung impedance to dynamic transpulmonary driving pressure
Measured: 40 minutes
Pendelluft
Occurrence of intra-tidal shift of gas within different lung regions at beginning of inspiration
Measured: 40 minutes
Work of breathing
Esophageal pressure simplified pressure time product per minute
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start22 Jan 2020
- Primary completion27 Jan 2021
- Study completion27 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
- Responsible party
- Sponsor
- Investigators
- Massimo Antonelli, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCSDomenico L Grieco, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241861
- Sponsor's protocol ID
- 2693
- Acronym
- HIGHFLOWHELMET
- Status last verified
- Jan 2020
- First submitted
- 22 Jan 2020
- Last updated
- 8 Feb 2021
- 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
Menga LS, Delle Cese L, Rosa T, Cesarano M, Scarascia R, Michi T, Biasucci DG, Ruggiero E, Dell'Anna AM, Cutuli SL, Tanzarella ES, Pintaudi G, De Pascale G, Sandroni C, Maggiore SM, Grieco DL, Antonelli M. Respective Effects of Helmet Pressure Support, Continuous Positive Airway Pressure, and Nasal High-Flow in Hypoxemic Respiratory Failure: A Randomized Crossover Clinical Trial. Am J Respir Crit Care Med. 2023 May 15;207(10):1310-1323. doi: 10.1164/rccm.202204-0629OC.
PubMed 36378814
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Comparison of High-flow Nasal Cannula, Helmet Pressure Support Ventilation and Continuous Positive Airway Pressure During Acute Hypoxemic Respiratory Failure: a Randomized Cross-over Study
- ClinicalTrials.gov ID
- NCT04241861
- Acronym / sponsor ID
- HIGHFLOWHELMET / 2693
- Conditions
- Respiratory Failure, Hypoxemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 27 Jan 2021 (actual)
- Study completion
- 27 Jan 2021 (actual)
- First posted
- 27 Jan 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.
The investigators designed a cross-over, randomized trial to assess the physiological effects of helmet pressure support ventilation (PSV) and continuous positive airway pressure (CPAP) as compared to high-flow nasal cannula during the early phase of acute hypoxemic respiratory failure
Detailed description
Setting: 21-bed general ICU, emergency room of the Emergency department (ED), Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS, Rome, Italy..
Patients: adult hypoxemic non-hypercapnic patients admitted to the emergency department or the ICU with de novo acute respiratory failure will be assessed for the enrolment.
Each eligible patient, in the absence of exclusion criteria, will receive 15 minutes of heated and humidified 60% oxygen at a rate of 50 l/min via a non-rebreathing face mask. An ABG will be then collected and PaO2/FiO2 ratio computed: given the high flows used, actual FiO2 will be approximated to the set one.
Nonhypercapnic patients with a PaO2/FiO2≤200 mmHg will be enrolled. In the absence of exclusion criteria and if all other inclusion in criteria are met, patients showing PaO2/FiO2≤300 and >200 mmHg will be treated according to the clinical practice eventually reassessed for the presence of oxygenation criterion subsequently.
Enrolled patients will receive all the interventions (helmet CPAP, PSV and high-flow nasal cannula) in a randomized, cross-over fashion, for 40 minutes each.
At the end of the study, the patient will receive the treatment that will be shown as more appropriate for the patient, according to the attending physician, who will be informed about the results of the study on the individual patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-flow oxygen therapy | Experimental | Other: Respiratory support (High-flow oxygen therapy)Nasal high flow oxygen therapy 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 comfort33. FiO2 will be titrated to obtain an SpO2≥92% and ≤98%. |
| Helmet PSV | Experimental | Other: Respiratory support (Helmet PSV)Dedicated helmets for noninvasive ventilation will be used and size will be chosen according to neck circumference or according to manufacturer recommendations. Each patient will be connected to a compressed-gas based ventilator through a bitube circuit with no humidification. The ventilator will be set in PSV, with the following suggested settings 34-38: 1. initial pressure support≥8-10 cmH2O and adequate to permit of a peak in the inspiratory flow of 100 l/min; 2. positive end-expiratory pressure=10-12 cmH2O and increased to achieve the oxygenation target according to the choice of the attending physician. 3. FiO2 will be titrated to obtain an SpO2≥92% and ≤98%. 4. Inspiratory flow trigger = 1 l/min or according to the practice of each institution; 5. fastest pressurization time; 6. expiratory trigger: 10-50% of the maximum inspiratory flow; 7. maximum inspiratory time 1.2 second. |
| Helmet CPAP | Experimental | Other: Respiratory support (Helmet CPAP)Dedicated helmets for noninvasive ventilation will be uses and size will be chosen according to neck circumference or according to manufacturer recommendations. Treatment will be delivered through a high-flow generator. The following settings will be applied: 1. Continuous air flow=50-60 L/min. 2. Expiratory positive end-expiratory pressure valve set to achieve a PEEP==10-12 cmH2O and eventually increased to achieve the oxygenation target according to the choice of the attending physician. 3. FiO2 will be titrated to obtain an SpO2≥92% and ≤98%. Pressure inside the helmet will be monitored with a manometer in order to maintain the set PEEP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients: adult hypoxemic non-hypercapnic patients admitted to the emergency department or the ICU with de novo acute respiratory failure will be assessed for the enrolment.
- Patients will be considered eligible whether all the following inclusion criteria are met:
- Respiratory rate>25 bpm.
- PaO2/FiO2 ≤200 in the supine position, measured after 15 minutes of high flow treatment with face mask (60 l/min, temperature of the humidification chamber set at 37°C, FiO2 set to achieve a SpO2 >92% and <98%). Given the use of the high flows, nominal FiO2 will be considered a reliable estimate of the actual one.
- PaCO2 <45mmHg
Key exclusion criteria (6 listed)
- Exacerbation of asthma or chronic obstructive pulmonary disease;
- Cardiogenic pulmonary oedema;
- Haemodynamic instability (Systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg) and/or lactic acidosis (lactate >5 mmol/L) and/or clinically diagnosed Shock
- Metabolic Acidosis (pH <7.30 with normal- or hypo-carbia);
- Glasgow coma scale <13;
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 |
|---|---|---|
| Respiratory support (High-flow oxygen therapy)Noninvasive respiratory support respiratory support | Other | High-flow oxygen therapy |
| Respiratory support (Helmet PSV)Noninvasive respiratory support respiratory support | Other | Helmet PSV |
| Respiratory support (Helmet CPAP)Noninvasive respiratory support respiratory support | Other | Helmet CPAP |
Primary outcome
Inspiratory effort
Time frame: 40 minutes
The negative deflection in esophageal pressure during inspiration
Tidal volume
Time frame: 40 minutes
The tidal change in lung impedance, assessed by electrical impedance tomography
14 secondary outcomes
Oxygenation
Time frame: 40 minutes
Tidal volume distribution
Time frame: 40 minutes
Carbon dioxide
Time frame: 40 minutes
Respiratory rate
Time frame: 40 minutes
Dyspnea
Time frame: 40 minutes
Comfort
Time frame: 40 minutes
Global impedance-derived End-expiratory lung volume
Time frame: 40 minutes
Regional impedance-derived End-expiratory lung volume
Time frame: 40 minutes
Dynamic transpulmonary driving pressure
Time frame: 40 minutes
Global impedance-derived lung dynamic strain
Time frame: 40 minutes
Regional impedance-derived lung dynamic strain
Time frame: 40 minutes
Respiratory system dynamic compliance
Time frame: 40 minutes
Pendelluft
Time frame: 40 minutes
Work of breathing
Time frame: 40 minutes
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 8 Feb 2021.
- Derived from this study: PubMed 36378814Menga LS, Delle Cese L, Rosa T, Cesarano M, Scarascia R, Michi T, Biasucci DG, Ruggiero E, Dell'Anna AM, Cutuli SL, Tanzarella ES, Pintaudi G, De Pascale G, Sandroni C, Maggiore SM, Grieco DL, Antonelli M. Respective Effects of Helmet Pressure Support, Continuous Positive Airway Pressure, and Nasal High-Flow in Hypoxemic Respiratory Failure: A Randomized Crossover Clinical Trial. Am J Respir Crit Care Med. 2023 May 15;207(10):1310-1323. doi: 10.1164/rccm.202204-0629OC.
- Individual participant dataSharing planned: Undecided. Data will be made available upon a reasonable request
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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.
Massimo Antonelli, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Domenico L Grieco, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory support (High-flow oxygen therapy), Respiratory support (Helmet PSV) and Respiratory support (Helmet CPAP) in people with Respiratory Failure and Hypoxemia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site 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 7 inclusion and 6 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 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Inspiratory effort (time frame: 40 minutes). The study lists 2 primary outcomes in all. 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 NCT04241861, which also lists 1 linked publication.
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 8 Feb 2021.