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COMPLETED NA

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

NCT02236559 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • DEVICE Vapotherm
  • DEVICE Noninvasive positive pressure ventilation (NIPPV)

Study Locations (5)

Texas

  • Memorial Hermann Hospital — Houston
  • Memorial Hermann The Woodlands — The Woodlands

Georgia

  • Athens Regional Medical Center — Athens

South Carolina

  • McLeod Regional Medical Center — Florence

Tennessee

  • Erlanger Health System — Chattanooga

Trial Details

FieldValue
Enrollment Target 204 participants
Start Date 2014-09
Est. Completion 2017-02
Phase NA

Sponsor

Vapotherm

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02236559

The ClinicalTrials.gov registry entry for NCT02236559 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 204 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vapotherm, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Acute Respiratory Failure appearing as the primary indexed condition, and to 2 interventions — of which Vapotherm is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02236559 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Texas, Georgia, South Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02236559 about?

NCT02236559 is a clinical study titled "High Flow Therapy for the Treatment of Respiratory Failure in the ED". 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 (NIPP...

What is the current status of trial NCT02236559?

This trial is currently completed. It is a NA study. The enrollment target is 204 participants. The study started on 2014-09. Estimated completion is 2017-02.

What conditions does trial NCT02236559 study?

This clinical trial studies the following conditions: Acute Respiratory Failure. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02236559?

The interventions under investigation include: Vapotherm (DEVICE), Noninvasive positive pressure ventilation (NIPPV) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02236559?

This trial is sponsored by Vapotherm, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02236559 being conducted?

This trial has 5 study locations across Georgia, South Carolina, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial