A Pilot Study Comparing Oxygen Delivery Via Helmet Interface Versus High Flow Nasal Cannula

Hypoxemic Respiratory Failure Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04035460
• Other study ID #: 952633
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: September 30, 2022

Study information

• Verified date: July 2021
• Source: Baystate Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoxemic Respiratory Failure
• Respiratory Insufficiency

Intervention

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.
• High Flow Nasal Oxygen
Large-bore nasal prongs through which oxygen is delivered at high flow rates

Locations

Country	Name	City	State
United States	Baystate Medical Center	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Baystate Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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