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

NCT04035460 | Unknown FDA Device

• 1 other identifier: 952633
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxemic Respiratory Failure

Keywords

non-invasive ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Time to intubation

  28 days

• Intubation-free days through day 28

  28 days

• Organ-failure-free days through day 28

  28 days

• Mortality prior to discharge from hospital (up to study day 90 whichever comes first)

  90 days

• Hospital mortality to day 28

  28 days

Study Arms (2)

Helmet oxygenation group

ACTIVE COMPARATOR

Patients randomized to helmet NIPPV will receive noninvasive oxygenation and ventilation via a latex free helmet

Device: Helmet

High Flow Nasal Oxygen

ACTIVE COMPARATOR

Oxygen will be passed through a heated humidifier and applied continuously through large-bore nasal prongs

Device: High Flow Nasal Oxygen

Interventions

Helmet DEVICE

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.

Helmet oxygenation group

High Flow Nasal Oxygen DEVICE

Large-bore nasal prongs through which oxygen is delivered at high flow rates

High Flow Nasal Oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Baystate Medical Center: lead

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Head Protective Devices

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Mark A Tidswell, MD

  Baystate Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and Surgery

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 29, 2019
• Study Start: June 1, 2018
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: July 22, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)