Clinical trial NCT04035460: A Pilot Study Comparing Oxygen Delivery Via Helmet Interface Versus High Flow Nasal Cannula
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
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoxemic Respiratory Failure
Keywords: non-invasive ventilation
Lead sponsor: Baystate Medical Center
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of intubation
timeFrame: 28 days
Secondary outcomes:
measure: Time to intubation
timeFrame: 28 days
measure: Intubation-free days through day 28
timeFrame: 28 days
measure: Organ-failure-free days through day 28
timeFrame: 28 days
measure: Mortality prior to discharge from hospital (up to study day 90 whichever comes first)
timeFrame: 90 days
measure: Hospital mortality to day 28
timeFrame: 28 days
measure: ICU free-days to day 28
timeFrame: 28 days
measure: Hospital length of stay
timeFrame: 28 days
measure: Rate of cross-over between groups
timeFrame: 28 days
measure: Complications
timeFrame: 28 days
measure: Ventilator associated pneumonia, barotrauma
timeFrame: 28 days
measure: Total daily dose of sedative medications (milligram)
timeFrame: 7 days
measure: Highest level of daily mobility through day 7
timeFrame: 7 days
measure: Tolerance of the devices
timeFrame: 28 days
measure: Rate and reason for exclusion from enrollment to this trial of Helmet-NIPPV vs. HFNC
timeFrame: through study completion, an average of 1 year
measure: Rate of intubation in non-enrolled patients that meet inclusion and exclusion criteria
timeFrame: 28 days
measure: Richmond Agitation and Sedation Scale (RASS)
timeFrame: 7 days
measure: Confusion Assessment Method for the ICU (CAM-ICU)
timeFrame: 7 days
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
Study officials:
affiliation: Baystate Medical Center
name: Mark A Tidswell, MD
role: PRINCIPAL_INVESTIGATOR
References: