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

Status unconfirmed · Not applicable

Conditions studied: Hypoxemic Respiratory Failure

In brief

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.

Key facts

Study ID

NCT04035460

Run by

Baystate Medical Center

People needed

1

Starts

2018-06-01

Expected to finish

2022-09-30

Last updated by the study team

2021-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Baystate Medical Center — Springfield, Massachusetts, United States

Full record on ClinicalTrials.gov

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