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A Pilot Study Comparing Oxygen Delivery Via Helmet Interface Versus High Flow Nasal Cannula (NOVA-pilot)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04035460
Recruitment Status : Active, not recruiting
First Posted : July 29, 2019
Last Update Posted : July 22, 2021
Information provided by (Responsible Party):
Mark Tidswell, Baystate Medical Center

Tracking Information
First Submitted Date  ICMJE July 16, 2019
First Posted Date  ICMJE July 29, 2019
Last Update Posted Date July 22, 2021
Actual Study Start Date  ICMJE June 1, 2018
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2019)
  • Time to intubation [ Time Frame: 28 days ]
    Hours and minutes from time of initiation of protocol until intubation
  • Intubation-free days through day 28 [ Time Frame: 28 days ]
    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
  • Organ-failure-free days through day 28 [ Time Frame: 28 days ]
    Daily determination of presence or absence of Cardiovascular, Kidney, Liver, Central Nervous System, and Hematological Dysfunction.
  • Mortality prior to discharge from hospital (up to study day 90 whichever comes first) [ Time Frame: 90 days ]
    hospital mortality
  • Hospital mortality to day 28 [ Time Frame: 28 days ]
    hospital mortality
  • ICU free-days to day 28 [ Time Frame: 28 days ]
    days not in ICU
  • Hospital length of stay [ Time Frame: 28 days ]
    duration of hospital stay
  • Rate of cross-over between groups [ Time Frame: 28 days ]
    The percentage of patients in each group crossed over to the alternative group or another form of noninvasive ventilation.
  • Complications [ Time Frame: 28 days ]
    Adverse events other than failure of the noninvasive oxygenation device
  • Ventilator associated pneumonia, barotrauma [ Time Frame: 28 days ]
    Complications due to mechanical ventilation
  • Total daily dose of sedative medications (milligram) [ Time Frame: 7 days ]
    Assessment of Sedation medications
  • Highest level of daily mobility through day 7 [ Time Frame: 7 days ]
    Activity level
  • Tolerance of the devices [ Time Frame: 28 days ]
    Daily assessment with visual analog scale for comfort, range 0-5, with 0= no discomfort and 5=unable to tolerate
  • 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 ]
    Reasons for exclusion of patients meeting inclusion criteria
  • Rate of intubation in non-enrolled patients that meet inclusion and exclusion criteria [ Time Frame: 28 days ]
    Usual care comparison
  • Richmond Agitation and Sedation Scale (RASS) [ Time Frame: 7 days ]
    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
  • Confusion Assessment Method for the ICU (CAM-ICU) [ Time Frame: 7 days ]
    Daily assessment of presence or absence of delirium
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Pilot Study Comparing Oxygen Delivery Via Helmet Interface Versus High Flow Nasal Cannula
Official Title  ICMJE 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)
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Hypoxemic Respiratory Failure
Intervention  ICMJE
  • Device: Helmet
    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.
  • Device: High Flow Nasal Oxygen
    Large-bore nasal prongs through which oxygen is delivered at high flow rates
Study Arms  ICMJE
  • Active Comparator: Helmet oxygenation group
    Patients randomized to helmet NIPPV will receive noninvasive oxygenation and ventilation via a latex free helmet
    Intervention: Device: Helmet
  • Active Comparator: High Flow Nasal Oxygen
    Oxygen will be passed through a heated humidifier and applied continuously through large-bore nasal prongs
    Intervention: Device: High Flow Nasal Oxygen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 21, 2021)
Original Estimated Enrollment  ICMJE
 (submitted: July 25, 2019)
Estimated Study Completion Date  ICMJE September 30, 2022
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 18 years
  2. 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.

  3. Respiratory rate (RR) ≥24 /min and/or subjective shortness of breath (Modified Borg Dyspnea Scale ≥ 2)

Exclusion Criteria:

  1. P/F Ratio < 100 (Severe ARDS) on quantifiable FiO2
  2. More than 24 hours has elapsed since the patient met criteria for AHRF (Inclusion #2 and 3, above)
  3. Urgent need for intubation

    Criteria for intubation:

    i. 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

  4. Contraindication to HFNC, Helmet-NIPPV, or Mask-NIPPV
  5. Upper airway obstruction, facial trauma
  6. Copious secretions, airway bleeding, epistaxis or vomiting
  7. Primary cause of respiratory failure is exacerbation of chronic obstructive pulmonary disease (COPD) or asthma
  8. Elevated intracranial pressure >20 mm Hg
  9. Home mechanical ventilation except for CPAP/BiPAP used solely for sleep disordered breathing
  10. 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)
  11. Plan for procedure during which NIPPV or HFNC is contraindicated. Okay to enroll if procedure is complete and AHRF persists within 24 hours.
  12. Absence of airway protective gag reflex or cough
  13. Tracheostomy
  14. Lack of informed consent
  15. Pregnancy
  16. Actual body weight exceeding 1 kg per cm of height
  17. Diffuse alveolar hemorrhage
  18. Severe acute pancreatitis as etiology for hypoxemia
  19. Recent upper gastrointestinal surgical anastomosis within the past 30 days
  20. Enrollment in another clinical trial within the past 30 days
  21. Unsuitable for non-invasive ventilation in the judgment of the treating MD
  22. Decision to withhold life-sustaining treatment. Patients with Do-Not-Resuscitate (DNR) or No Cardiopulmonary resuscitation (No CPR) order may be enrolled.
  23. Do not intubate order
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04035460
Other Study ID Numbers  ICMJE 952633
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mark Tidswell, Baystate Medical Center
Study Sponsor  ICMJE Baystate Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark A Tidswell, MD Baystate Medical Center
PRS Account Baystate Medical Center
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP