Hypoxemic Respiratory FailureNOVA-pilotNCT04035460
A Pilot Study Comparing Oxygen Delivery Via Helmet Interface Versus High Flow Nasal Cannula
A study testing Helmet and High Flow Nasal Oxygen in people with Hypoxemic Respiratory Failure, run by Baystate Medical Center at 1 site in United States.
Trial summary
Our main objective is to collect feasibility data on helmet NIPPV and other clinical elements in to eventually prepare for a full scale randomized trial based on findings of this pilot study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemic Respiratory Failure
- What is being tested?
- Helmet and High Flow Nasal Oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 30 Sep 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
- Age ≥ 18 years
- AHRF defined as:
- A ratio of partial pressure of oxygen (PaO2) to fraction of inspired oxygen (FiO2) between 100 - 250 mm Hg while breathing O2 from Venturi mask, or other delivery system that allows quantification of FiO2 such as Mask-NIPPV or HFNC.
- When no arterial blood gas (ABG) result available, use transcutaneous oxygen saturation measurement (SpO2) to impute PaO2 (Appendix A.2 for Table of PaO2 / FiO2 imputed from SpO2 [Brown 2017]. If no oxygenation data prior to use of Mask-NIPPV or HFNC are available, then P/F ratio 100 - 250 on Mask-NIPPV or HFNC meets this criterion.
- Respiratory rate (RR) ≥24 /min and/or subjective shortness of breath (Modified Borg Dyspnea Scale ≥ 2)
Who cannot join
- P/F Ratio < 100 (Severe ARDS) on quantifiable FiO2
- More than 24 hours has elapsed since the patient met criteria for AHRF (Inclusion #2 and 3, above)
- Urgent need for intubation
- Criteria for intubation:
- RR>40 ii. Lack of improvement of respiratory muscle fatigue iii. Copious tracheal secretions that require frequent suctioning iv. Acidosis with a potential Hydrogen (pH) <7.35 v. Acute hypercarbia (PaCO2 > 45 mm Hg) vi. SpO2 < 88% for more than 5 minutes despite FiO2 and non-invasive support vii. Respiratory or cardiac arrest viii. Glasgow Coma Scale ≤ 8
- Contraindication to HFNC, Helmet-NIPPV, or Mask-NIPPV
Show all 25Show fewer
- Upper airway obstruction, facial trauma
- Copious secretions, airway bleeding, epistaxis or vomiting
- Primary cause of respiratory failure is exacerbation of chronic obstructive pulmonary disease (COPD) or asthma
- Elevated intracranial pressure >20 mm Hg
- Home mechanical ventilation except for CPAP/BiPAP used solely for sleep disordered breathing
- Persistent hemodynamic instability (systolic blood pressure (SBP)<90 or mean arterial pressure (MAP)<60 despite IV fluid resuscitation, or norepinephrine dose > 0.1 mcg/kg/min or equivalent vasopressor dose)
- Plan for procedure during which NIPPV or HFNC is contraindicated. Okay to enroll if procedure is complete and AHRF persists within 24 hours.
- Absence of airway protective gag reflex or cough
- Tracheostomy
- Lack of informed consent
- Pregnancy
- Actual body weight exceeding 1 kg per cm of height
- Diffuse alveolar hemorrhage
- Severe acute pancreatitis as etiology for hypoxemia
- Recent upper gastrointestinal surgical anastomosis within the past 30 days
- Enrollment in another clinical trial within the past 30 days
- Unsuitable for non-invasive ventilation in the judgment of the treating MD
- Decision to withhold life-sustaining treatment. Patients with Do-Not-Resuscitate (DNR) or No Cardiopulmonary resuscitation (No CPR) order may be enrolled.
- Do not intubate order
Trial locations and contacts
1 site in 1 country.
United States1 site
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
Official title: A Pilot Randomized Controlled Study of Non-invasive Oxygenation and Ventilation in Patients With Acute Hypoxemic Respiratory Failure (AHRF): A Comparison of Oxygen Delivery Via Helmet Interface Versus High Flow Nasal Cannula (HFNC)
Our main objective is to collect feasibility data on helmet NIPPV and other clinical elements in to eventually prepare for a full scale randomized trial based on findings of this pilot study.
Read the detailed description
Patients with acute hypoxemia leading to respiratory failure are frequently supported by endotracheal intubation and mechanical ventilation. Unfortunately an invasive approach to support is associated with risks of lung injury, infection, need for heavy sedation, and increased mortality. Non-invasive oxygen delivery, by mask (BiPAP or CPAP), high flow nasal cannula or helmet interface, is better tolerated and reduces risks associated with invasive mechanical ventilation. A growing body of medical literature and clinical experience suggests that non-invasive oxygen delivery can prevent the need for endotracheal intubation in some patients. This proposal will compare two different modes of non-invasive oxygen delivery: helmet and high flow nasal cannula.
- Conditions
- Hypoxemic Respiratory Failure
- Being tested
- Helmet, High Flow Nasal Oxygen
- Keywords
- non-invasive ventilation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HelmetDevice
The helmet encloses the head and neck of the patient, has a rigid ring and is secured by 2 armpit braces. A soft collar adheres to the neck and ensures a sealed connection once the helmet is inflated.
High Flow Nasal OxygenDevice
Large-bore nasal prongs through which oxygen is delivered at high flow rates
| Study group | Role | What they receive |
|---|---|---|
| Helmet oxygenation group | Active comparator | Patients randomized to helmet NIPPV will receive noninvasive oxygenation and ventilation via a latex free helmet Receives: Device: Helmet |
| High Flow Nasal Oxygen | Active comparator | Oxygen will be passed through a heated humidifier and applied continuously through large-bore nasal prongs Receives: Device: High Flow Nasal Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of intubation
To determine the rates of intubation for subjects with Acute Hypoxemic Respiratory Failure (AHRF) managed by non-invasive modalities High Flow Nasal Cannula (HFNC) and Helmet NIPPV.
Measured: 28 days
Secondary outcomes (17)
Time to intubation
Hours and minutes from time of initiation of protocol until intubation
Measured: 28 days
Intubation-free days through day 28
number of days from the time of randomization to day 28 after randomization on which the patient is not intubated and does not require invasive mechanical ventilation
Measured: 28 days
Organ-failure-free days through day 28
Daily determination of presence or absence of Cardiovascular, Kidney, Liver, Central Nervous System, and Hematological Dysfunction.
Measured: 28 days
Mortality prior to discharge from hospital (up to study day 90 whichever comes first)
hospital mortality
Measured: 90 days
Hospital mortality to day 28
hospital mortality
Measured: 28 days
ICU free-days to day 28
days not in ICU
Measured: 28 days
Hospital length of stay
duration of hospital stay
Measured: 28 days
Rate of cross-over between groups
The percentage of patients in each group crossed over to the alternative group or another form of noninvasive ventilation.
Measured: 28 days
Complications
Adverse events other than failure of the noninvasive oxygenation device
Measured: 28 days
Ventilator associated pneumonia, barotrauma
Complications due to mechanical ventilation
Measured: 28 days
Total daily dose of sedative medications (milligram)
Assessment of Sedation medications
Measured: 7 days
Highest level of daily mobility through day 7
Activity level
Measured: 7 days
Tolerance of the devices
Daily assessment with visual analog scale for comfort, range 0-5, with 0= no discomfort and 5=unable to tolerate
Measured: 28 days
Rate and reason for exclusion from enrollment to this trial of Helmet-NIPPV vs. HFNC
Reasons for exclusion of patients meeting inclusion criteria
Measured: through study completion, an average of 1 year
Rate of intubation in non-enrolled patients that meet inclusion and exclusion criteria
Usual care comparison
Measured: 28 days
Richmond Agitation and Sedation Scale (RASS)
Highest daily RASS score. The scale range is -5 to +4 in integer increments, Where -5 is unarousable, 0 is alert and calm, and +4 is combative
Measured: 7 days
Confusion Assessment Method for the ICU (CAM-ICU)
Daily assessment of presence or absence of delirium
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start1 Jun 2018
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baystate Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Tidswell, Baystate Medical Center
- Investigators
- Mark A Tidswell, MD, Principal investigator, Baystate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035460
- Sponsor's protocol ID
- 952633
- Acronym
- NOVA-pilot
- Status last verified
- Jul 2021
- First submitted
- 16 Jul 2019
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Study of Non-invasive Oxygenation and Ventilation in Patients With Acute Hypoxemic Respiratory Failure (AHRF): A Comparison of Oxygen Delivery Via Helmet Interface Versus High Flow Nasal Cannula (HFNC)
- ClinicalTrials.gov ID
- NCT04035460
- Acronym / sponsor ID
- NOVA-pilot / 952633
- Conditions
- Hypoxemic Respiratory Failure
- Keywords
- non-invasive ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Baystate Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 29 Jul 2019 (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.
Our main objective is to collect feasibility data on helmet NIPPV and other clinical elements in to eventually prepare for a full scale randomized trial based on findings of this pilot study.
Detailed description
Patients with acute hypoxemia leading to respiratory failure are frequently supported by endotracheal intubation and mechanical ventilation. Unfortunately an invasive approach to support is associated with risks of lung injury, infection, need for heavy sedation, and increased mortality. Non-invasive oxygen delivery, by mask (BiPAP or CPAP), high flow nasal cannula or helmet interface, is better tolerated and reduces risks associated with invasive mechanical ventilation. A growing body of medical literature and clinical experience suggests that non-invasive oxygen delivery can prevent the need for endotracheal intubation in some patients. This proposal will compare two different modes of non-invasive oxygen delivery: helmet and high flow nasal cannula.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Helmet oxygenation group | Active comparator | Device: HelmetPatients randomized to helmet NIPPV will receive noninvasive oxygenation and ventilation via a latex free helmet |
| High Flow Nasal Oxygen | Active comparator | Device: High Flow Nasal OxygenOxygen will be passed through a heated humidifier and applied continuously through large-bore nasal prongs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- AHRF defined as:
- A ratio of partial pressure of oxygen (PaO2) to fraction of inspired oxygen (FiO2) between 100 - 250 mm Hg while breathing O2 from Venturi mask, or other delivery system that allows quantification of FiO2 such as Mask-NIPPV or HFNC.
- When no arterial blood gas (ABG) result available, use transcutaneous oxygen saturation measurement (SpO2) to impute PaO2 (Appendix A.2 for Table of PaO2 / FiO2 imputed from SpO2 [Brown 2017]. If no oxygenation data prior to use of Mask-NIPPV or HFNC are available, then P/F ratio 100 - 250 on Mask-NIPPV or HFNC meets this criterion.
- Respiratory rate (RR) ≥24 /min and/or subjective shortness of breath (Modified Borg Dyspnea Scale ≥ 2)
Key exclusion criteria (25 listed)
- P/F Ratio < 100 (Severe ARDS) on quantifiable FiO2
- More than 24 hours has elapsed since the patient met criteria for AHRF (Inclusion #2 and 3, above)
- Urgent need for intubation
- Contraindication to HFNC, Helmet-NIPPV, or Mask-NIPPV
- Upper airway obstruction, facial trauma
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 |
|---|---|---|
| HelmetThe helmet encloses the head and neck of the patient, has a rigid ring and is secured by 2 armpit braces. A soft collar adheres to the neck and ensures a sealed connection once the helmet is inflated. | Device | Helmet oxygenation group |
| High Flow Nasal OxygenLarge-bore nasal prongs through which oxygen is delivered at high flow rates | Device | High Flow Nasal Oxygen |
Primary outcome
Rate of intubation
Time frame: 28 days
To determine the rates of intubation for subjects with Acute Hypoxemic Respiratory Failure (AHRF) managed by non-invasive modalities High Flow Nasal Cannula (HFNC) and Helmet NIPPV.
17 secondary outcomes
Time to intubation
Time frame: 28 days
Intubation-free days through day 28
Time frame: 28 days
Organ-failure-free days through day 28
Time frame: 28 days
Mortality prior to discharge from hospital (up to study day 90 whichever comes first)
Time frame: 90 days
Hospital mortality to day 28
Time frame: 28 days
ICU free-days to day 28
Time frame: 28 days
Hospital length of stay
Time frame: 28 days
Rate of cross-over between groups
Time frame: 28 days
Complications
Time frame: 28 days
Ventilator associated pneumonia, barotrauma
Time frame: 28 days
Total daily dose of sedative medications (milligram)
Time frame: 7 days
Highest level of daily mobility through day 7
Time frame: 7 days
Tolerance of the devices
Time frame: 28 days
Rate and reason for exclusion from enrollment to this trial of Helmet-NIPPV vs. HFNC
Time frame: through study completion, an average of 1 year
Rate of intubation in non-enrolled patients that meet inclusion and exclusion criteria
Time frame: 28 days
Richmond Agitation and Sedation Scale (RASS)
Time frame: 7 days
Confusion Assessment Method for the ICU (CAM-ICU)
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Individual participant dataSharing planned: No
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Acute Respiratory Distress Syndrome (ARDS), Acute Hypoxemic Respiratory Failure
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Brain-lung Interaction During Acute Respiratory Failure
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Interleukin-6 Guided Treatment With Dexamethasone or Tocilizumab in Patients Hospitalized With Acute Respiratory Symptoms - a Feasibility Study
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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.
Mark A Tidswell, MD principal investigator
Baystate Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helmet and High Flow Nasal Oxygen in people with Hypoxemic Respiratory Failure, run by Baystate Medical Center at 1 site in United States.
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 5 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 22 Jul 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 United States. 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?
Results are not available in the source record.
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?
Rate of intubation (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2021.