Back to resultsA Pilot Study Comparing Oxygen Delivery Via Helmet Interface Versus High Flow Nasal Cannula (NOVA-pilot)
Primary Purpose
Hypoxemic Respiratory Failure
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Helmet
High Flow Nasal Oxygen
Sponsored by
About this trial
This is an interventional prevention trial for Hypoxemic Respiratory Failure focused on measuring non-invasive ventilation
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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:
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
- Contraindication to HFNC, Helmet-NIPPV, or Mask-NIPPV
- 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
Sites / Locations
- Baystate Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Helmet oxygenation group
High Flow Nasal Oxygen
Arm Description
Patients randomized to helmet NIPPV will receive noninvasive oxygenation and ventilation via a latex free helmet
Oxygen will be passed through a heated humidifier and applied continuously through large-bore nasal prongs
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Time to intubation
Hours and minutes from time of initiation of protocol until intubation
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
Organ-failure-free days through day 28
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)
hospital mortality
Hospital mortality to day 28
hospital mortality
ICU free-days to day 28
days not in ICU
Hospital length of stay
duration of hospital stay
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.
Complications
Adverse events other than failure of the noninvasive oxygenation device
Ventilator associated pneumonia, barotrauma
Complications due to mechanical ventilation
Total daily dose of sedative medications (milligram)
Assessment of Sedation medications
Highest level of daily mobility through day 7
Activity level
Tolerance of the devices
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
Reasons for exclusion of patients meeting inclusion criteria
Rate of intubation in non-enrolled patients that meet inclusion and exclusion criteria
Usual care comparison
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
Confusion Assessment Method for the ICU (CAM-ICU)
Daily assessment of presence or absence of delirium
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04035460
Brief Title
A Pilot Study Comparing Oxygen Delivery Via Helmet Interface Versus High Flow Nasal Cannula
Acronym
NOVA-pilot
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baystate Medical Center
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemic Respiratory Failure
Keywords
non-invasive ventilation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Helmet oxygenation group
Arm Type
Active Comparator
Arm Description
Patients randomized to helmet NIPPV will receive noninvasive oxygenation and ventilation via a latex free helmet
Arm Title
High Flow Nasal Oxygen
Arm Type
Active Comparator
Arm Description
Oxygen will be passed through a heated humidifier and applied continuously through large-bore nasal prongs
Intervention Type
Device
Intervention Name(s)
Helmet
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
High Flow Nasal Oxygen
Intervention Description
Large-bore nasal prongs through which oxygen is delivered at high flow rates
Primary Outcome Measure Information:
Title
Rate of intubation
Description
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.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Time to intubation
Description
Hours and minutes from time of initiation of protocol until intubation
Time Frame
28 days
Title
Intubation-free days through day 28
Description
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
Time Frame
28 days
Title
Organ-failure-free days through day 28
Description
Daily determination of presence or absence of Cardiovascular, Kidney, Liver, Central Nervous System, and Hematological Dysfunction.
Time Frame
28 days
Title
Mortality prior to discharge from hospital (up to study day 90 whichever comes first)
Description
hospital mortality
Time Frame
90 days
Title
Hospital mortality to day 28
Description
hospital mortality
Time Frame
28 days
Title
ICU free-days to day 28
Description
days not in ICU
Time Frame
28 days
Title
Hospital length of stay
Description
duration of hospital stay
Time Frame
28 days
Title
Rate of cross-over between groups
Description
The percentage of patients in each group crossed over to the alternative group or another form of noninvasive ventilation.
Time Frame
28 days
Title
Complications
Description
Adverse events other than failure of the noninvasive oxygenation device
Time Frame
28 days
Title
Ventilator associated pneumonia, barotrauma
Description
Complications due to mechanical ventilation
Time Frame
28 days
Title
Total daily dose of sedative medications (milligram)
Description
Assessment of Sedation medications
Time Frame
7 days
Title
Highest level of daily mobility through day 7
Description
Activity level
Time Frame
7 days
Title
Tolerance of the devices
Description
Daily assessment with visual analog scale for comfort, range 0-5, with 0= no discomfort and 5=unable to tolerate
Time Frame
28 days
Title
Rate and reason for exclusion from enrollment to this trial of Helmet-NIPPV vs. HFNC
Description
Reasons for exclusion of patients meeting inclusion criteria
Time Frame
through study completion, an average of 1 year
Title
Rate of intubation in non-enrolled patients that meet inclusion and exclusion criteria
Description
Usual care comparison
Time Frame
28 days
Title
Richmond Agitation and Sedation Scale (RASS)
Description
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
Time Frame
7 days
Title
Confusion Assessment Method for the ICU (CAM-ICU)
Description
Daily assessment of presence or absence of delirium
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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:
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
Contraindication to HFNC, Helmet-NIPPV, or Mask-NIPPV
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A Tidswell, MD
Organizational Affiliation
Baystate Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Pilot Study Comparing Oxygen Delivery Via Helmet Interface Versus High Flow Nasal Cannula
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