High Flow Therapy for the Treatment of Respiratory Failure in the ED

NCT02236559 | Completed Results DMC

• 1 other identifier: RP-EDPF2014001Dev
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 5

Brief Summary

The overall objective of this study is to determine if Vapotherm high flow nasal cannula therapy (HFT), when used to treat respiratory failure in the ED, is at least equivalent to the current standard of care for non-invasive ventilatory support, non-invasive positive pressure mask ventilation (NIPPV). Moreover, this study will investigate the potential that HFT has possible advantages over NIPPV, such as decreased time to patient stability from respiratory failure, and the ease of use as a first line intervention for respiratory failure in the ED environment. The hypothesis is that HFT via the Vapotherm Precision Flow will demonstrate clinical non-inferiority when compared to NIPPV with regard to treatment failure by way of an impact on ventilation indices and a lower intolerance rate, and have a positive association with hospital disposition and length of stay.

Conditions

Acute Respiratory Failure

Keywords

high flow therapy; high flow nasal cannula; acute respiratory failure; noninvasive ventilation

Outcome Measures

Primary Outcomes (1)

• Treatment Failure Rate

  Determine the efficacy of HFT compared to NIPPV in treating respiratory failure. The primary endpoint will be treatment failure within 72 hrs as determined by intubation.

  Within 72 hrs

Secondary Outcomes (10)

• Ventilatory Indices 1

  At one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).

• Ventilatory Indices 2

  At baseline, 30 minutes, 60 minutes, 90 minutes, 4 hours, and treatment failure if applicable

• Ventilatory Indices 3

  At one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).

• Ventilatory Indices 4

  At one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).

• Ventilatory Indices 5

  at baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable)

Study Arms (2)

Noninvasive positive pressure ventilation

ACTIVE COMPARATOR

Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV. Initial pressures will be at low end of suggested range but can be increased as rapidly as necessary to alleviate respiratory distress. Targets should be to lower respiratory rate to the low 20s and achieve tidal volumes of 6-8 ml/kg ideal body weight. If patients find pressures uncomfortably high, they can be lowered as necessary by 1 to 2 cmH2O decrements to enhance tolerance. EPAP (PEEP) can also be adjusted upward as needed to reduce triggering effort (by counterbalancing auto-PEEP) or to improve oxygenation. FIO2 will be 1.0 initially to assure adequate oxygenation, but should be adjusted promptly to maintain an FIO2 of no greater than 0.6 with an EPAP (PEEP) of not more than 10 cm H2O to maintain a PaO2 \> 88%.

Device: Noninvasive positive pressure ventilation (NIPPV)

High flow therapy

EXPERIMENTAL

Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. Initial flow will be set to 35 L/min but can be decreased or increased as rapidly as necessary to alleviate respiratory distress and optimize patient comfort. Targets should be to lower respiratory rate to the low 20s and with a HFT flow rate between 20 to 35 L/min. Starting temperature will be between 35 to 37 C; if patients find the gas temperature to be uncomfortable, it can be lowered as necessary down to 33 C to enhance tolerance. FIO2 will be 1.0 initially to assure adequate oxygenation, but should be adjusted promptly to maintain an FIO2 of no greater than 0.6 to maintain a PaO2 \> 88%.

Device: Vapotherm

Interventions

Noninvasive positive pressure ventilation (NIPPV) DEVICE

Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV. Initial pressures will be at low end of suggested range but can be increased as rapidly as necessary to alleviate respiratory distress. Targets should be to lower respiratory rate to the low 20s and achieve tidal volumes of 6-8 ml/kg ideal body weight. If patients find pressures uncomfortably high, they can be lowered as necessary by 1 to 2 cmH2O decrements to enhance tolerance. EPAP (PEEP) can also be adjusted upward as needed to reduce triggering effort (by counterbalancing auto-PEEP) or to improve oxygenation. FIO2 will be 1.0 initially to assure adequate oxygenation, but should be adjusted promptly to maintain an FIO2 of no greater than 0.6 with an EPAP (PEEP) of not more than 10 cm H2O to maintain a PaO2 \> 88%.

Also known as: BIPAP

Noninvasive positive pressure ventilation

Vapotherm DEVICE

Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. Initial flow will be set to 35 L/min but can be decreased or increased as rapidly as necessary to alleviate respiratory distress and optimize patient comfort. Targets should be to lower respiratory rate to the low 20s and with a HFT flow rate between 20 to 35 L/min. Starting temperature will be between 35 to 37 C; if patients find the gas temperature to be uncomfortable, it can be lowered as necessary down to 33 C to enhance tolerance. FIO2 will be 1.0 initially to assure adequate oxygenation, but should be adjusted promptly to maintain an FIO2 of no greater than 0.6 to maintain a PaO2 \> 88%.

Also known as: High flow nasal cannula

High flow therapy

Eligibility Criteria

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

You may qualify if:

• Adult patients (\> 18 yrs of age)
• Presentation with acute respiratory failure according to the following criteria:
• If any of these are present: Respiratory Rate \>22 or labored; Suspected Acute Respiratory Acidosis, as defined as pH \<7.32 on initial blood gas(either arterial or venous); Hypoxemia, as defined as Pulse Ox \<92%;
• Clinical decision to escalate therapy to non-invasive ventilatory support, or to maintain non-invasive ventilatory support if delivered to the ED on such.

You may not qualify if:

• Suspected drug overdose
• Cardiovascular instability as demonstrated by hypotension relative to initial clinical presentation that requires immediate intervention
• End stage cancer
• Life expectancy \< 6 months
• Respiratory arrest or significant respiratory depression on presentation
• Glasgow Coma Scale score \< 9
• Cardiac arrest on initial presentation
• Need for emergent intubation
• Known or suspected cerebrovascular accident
• Known or suspected ST segment elevation myocardial infarction
• Patients with increased risk of pulmonary aspiration
• Agitation or uncooperativeness

Sponsors & Collaborators

• Vapotherm, Inc.: lead
• University of Texas: collaborator
• Memorial Hermann Texas Medical Center: collaborator
• Piedmont Athens Regional Medical Center: collaborator
• University of Tennessee: collaborator
• Erlanger Medical Center: collaborator
• Memorial Hermann The Woodlands: collaborator
• McLeod Regional Medical Center: collaborator

Study Sites (5)

Athens Regional Medical Center

Athens, Georgia, 30606, United States

Location

McLeod Regional Medical Center

Florence, South Carolina, 29506, United States

Location

Erlanger Health System

Chattanooga, Tennessee, 37403, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Memorial Hermann The Woodlands

The Woodlands, Texas, 77380, United States

Location

Related Publications (1)

• Doshi P, Whittle JS, Bublewicz M, Kearney J, Ashe T, Graham R, Salazar S, Ellis TW Jr, Maynard D, Dennis R, Tillotson A, Hill M, Granado M, Gordon N, Dunlap C, Spivey S, Miller TL. High-Velocity Nasal Insufflation in the Treatment of Respiratory Failure: A Randomized Clinical Trial. Ann Emerg Med. 2018 Jul;72(1):73-83.e5. doi: 10.1016/j.annemergmed.2017.12.006. Epub 2018 Jan 6.

  PMID: 29310868 DERIVED

Results Point of Contact

• Title: Dr. Pratik Doshi, MD
• Organization: McGovern Medical School at The University of Texas Health Science Center at Houston

pratik.b.doshi@uth.tmc.edu

Study Officials

• Pratik B Doshi, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

• Thomas L Miller, PhD

  Vapotherm, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2014
• First Posted: September 10, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: February 1, 2017
• Last Updated: May 23, 2019
• Results First Posted: May 23, 2019

Record last verified: 2019-04

Locations

US (5)