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

Not Applicable

• Conditions: Hypoxemic Respiratory Failure
• Interventions: Device: Helmet; Device: High Flow Nasal Oxygen

• Registration Number: NCT04035460
• Lead Sponsor: Baystate Medical Center

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 Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2019-07-16
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-29
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-21
• Last Update Posted: 2021-07-22
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Helmet oxygenation group	Helmet	Patients randomized to helmet NIPPV will receive noninvasive oxygenation and ventilation via a latex free helmet
High Flow Nasal Oxygen	High Flow Nasal Oxygen	Oxygen will be passed through a heated humidifier and applied continuously through large-bore nasal prongs

Primary Outcome Measures

Name	Time	Method
Rate of intubation	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.

Secondary Outcome Measures

Name	Time	Method
Complications	28 days	Adverse events other than failure of the noninvasive oxygenation device
Ventilator associated pneumonia, barotrauma	28 days	Complications due to mechanical ventilation
ICU free-days to day 28	28 days	days not in ICU
Total daily dose of sedative medications (milligram)	7 days	Assessment of Sedation medications
Intubation-free days through day 28	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
Rate of cross-over between groups	28 days	The percentage of patients in each group crossed over to the alternative group or another form of noninvasive ventilation.
Tolerance of the devices	28 days	Daily assessment with visual analog scale for comfort, range 0-5, with 0= no discomfort and 5=unable to tolerate
Richmond Agitation and Sedation Scale (RASS)	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
Highest level of daily mobility through day 7	7 days	Activity level
Rate and reason for exclusion from enrollment to this trial of Helmet-NIPPV vs. HFNC	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	28 days	Usual care comparison
Hospital length of stay	28 days	duration of hospital stay
Time to intubation	28 days	Hours and minutes from time of initiation of protocol until intubation
Organ-failure-free days through day 28	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)	90 days	hospital mortality
Hospital mortality to day 28	28 days	hospital mortality
Confusion Assessment Method for the ICU (CAM-ICU)	7 days	Daily assessment of presence or absence of delirium

Trial Locations

Locations (1)

Baystate Medical Center; 🇺🇸 Springfield, Massachusetts, United States