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

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ClinicalTrials.gov Identifier: NCT02236559
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : May 11, 2017
Sponsor:
Collaborators:
University of Texas
Memorial Hermann Texas Medical Center
Piedmont Athens Regional Medical Center
University of Tennessee
Erlanger Medical Center
Memorial Hermann The Woodlands
McLeod Regional Medical Center
Information provided by (Responsible Party):
Vapotherm, Inc.

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.


Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Device: Noninvasive positive pressure ventilation (NIPPV) Device: Vapotherm Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Vapotherm High Flow Therapy for the Treatment of Respiratory Failure in the ED: A Randomized Controlled Trial
Study Start Date : September 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : February 2017


Arm Intervention/treatment
Active Comparator: Noninvasive positive pressure ventilation

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)

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%.

Other Name: BIPAP

Experimental: High flow therapy

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
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%.
Other Name: High flow nasal cannula




Primary Outcome Measures :
  1. Treatment failure rate [ Time Frame: Within 72 hrs ]
    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 intolerance, failure to adequately oxygenate or ventilate and medical deterioration. The data will be sub-analyzed for intubation within the ED and within the first 4 hrs of treatment.


Secondary Outcome Measures :
  1. Ventilatory indices [ Time Frame: At one and four hours ]
    Evaluate the capability of HFT, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. These indices of ventilation will be blood gas/chemistry analyses taken at baseline (presentation) and the follow up periods 1 hr and 4 hr (if still on therapy); vital signs (heart rate, respiratory rate, perceived dyspnea/comfort level) recorded at baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable); and clinician perception of efficacy recorded at the end of the treatment period.


Other Outcome Measures:
  1. Post emergency department discharge disposition [ Time Frame: Within 72 hrs ]
    Evaluate the impact of HFT compared to NIPPV on post ED discharge disposition and hospital stays for the first 72 hrs after presentation to the ED. The tertiary endpoint will be to compare the treatment groups with respect to time spent in the ED, ICU, medical floors and outpatient step-down units. Disposition and length of stay in any unit is at the discretion of the medical team treating the patient.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236559


Locations
United States, Georgia
Athens Regional Medical Center
Athens, Georgia, United States, 30606
United States, South Carolina
McLeod Regional Medical Center
Florence, South Carolina, United States, 29506
United States, Tennessee
Erlanger Health System
Chattanooga, Tennessee, United States, 37403
United States, Texas
Memorial Hermann Hospital
Houston, Texas, United States, 77030
Memorial Hermann The Woodlands
The Woodlands, Texas, United States, 77380
Sponsors and Collaborators
Vapotherm, Inc.
University of Texas
Memorial Hermann Texas Medical Center
Piedmont Athens Regional Medical Center
University of Tennessee
Erlanger Medical Center
Memorial Hermann The Woodlands
McLeod Regional Medical Center
Investigators
Principal Investigator: Pratik B Doshi, MD University of Texas
Study Director: Thomas L Miller, PhD Vapotherm, Inc.

Responsible Party: Vapotherm, Inc.
ClinicalTrials.gov Identifier: NCT02236559     History of Changes
Other Study ID Numbers: RP-EDPF2014001Dev
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017

Keywords provided by Vapotherm, Inc.:
high flow therapy
high flow nasal cannula
acute respiratory failure
noninvasive ventilation

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Benzocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents