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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypoxemic Respiratory Failure
• Intervention / Treatment: Device: Helmet; Device: High Flow Nasal Oxygen

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: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Helmet oxygenation group; Patients randomized to helmet NIPPV will receive noninvasive oxygenation and ventilation via a latex free helmet	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.
ACTIVE_COMPARATOR: High Flow Nasal Oxygen; Oxygen will be passed through a heated humidifier and applied continuously through large-bore nasal prongs	Device: High Flow Nasal Oxygen; Large-bore nasal prongs through which oxygen is delivered at high flow rates

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to intubation	Hours and minutes from time of initiation of protocol until intubation	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	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.	28 days
Mortality prior to discharge from hospital (up to study day 90 whichever comes first)	hospital mortality	90 days
Hospital mortality to day 28	hospital mortality	28 days
ICU free-days to day 28	days not in ICU	28 days
Hospital length of stay	duration of hospital stay	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.	28 days
Complications	Adverse events other than failure of the noninvasive oxygenation device	28 days
Ventilator associated pneumonia, barotrauma	Complications due to mechanical ventilation	28 days
Total daily dose of sedative medications (milligram)	Assessment of Sedation medications	7 days
Highest level of daily mobility through day 7	Activity level	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	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	through study completion, an average of 1 year
Rate of intubation in non-enrolled patients that meet inclusion and exclusion criteria	Usual care comparison	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	7 days
Confusion Assessment Method for the ICU (CAM-ICU)	Daily assessment of presence or absence of delirium	7 days

Collaborators and Investigators

• Sponsor: Baystate Medical Center
• Investigators: Principal Investigator: Mark A Tidswell, MD, Baystate Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2018
• Primary Completion (ANTICIPATED): September 30, 2022
• Study Completion (ANTICIPATED): September 30, 2022

Study Registration Dates

• First Submitted: July 16, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (ACTUAL): July 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: non-invasive ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 952633

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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