Status:
UNKNOWN
A Pilot Study Comparing Oxygen Delivery Via Helmet Interface Versus High Flow Nasal Cannula
Lead Sponsor:
Baystate Medical Center
Conditions:
Hypoxemic Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04035460
Start Date
June 1 2018
End Date
September 30 2022
Last Update
July 22 2021
Active Locations (1)
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1
Baystate Medical Center
Springfield, Massachusetts, United States, 01199