An interventional study of Vapotherm High Flow Therapy and Non-invasive positive pressure ventilation in Pulmonary Disease, Chronic Obstructive and Respiratory Insufficiency, sponsored by Vapotherm, Inc.. Withdrawn at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2020-09-16.
Sponsored by Vapotherm, Inc. · Not applicable, Interventional, and Treatment
The aim of this study is to see if the Vapotherm High Flow Therapy (HFT) device is effective to provide breathing support to patients with Chronic Obstructive Pulmonary Disease or COPD. The investigators believe that patients using HFT will not require as much use of therapies that provide pressure through a face mask, and are already recognized by FDA as support therapies for respiratory insufficiency.
The overall objective of this study is to demonstrate that Vapotherm High Flow Therapy (HFT) via nasal cannula provides respiratory support to patients with COPD as a primary diagnosis, who present with respiratory insufficiency in the Emergency Department. We intend to demonstrate that Vapotherm HFT via nasal cannula will result in at least equivalent patient outcomes as the current standard of care, while eliminating the need for other non-invasive respiratory support devices cleared for the treatment of respiratory insufficiency. The current standard of care will include the use of other devices cleared by the FDA as respiratory assist devices for the treatment of adult respiratory insufficiency.
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Exclusion Criteria:
Use of High Flow Therapy for support of Respiratory Insufficiency
Device: Vapotherm High Flow Therapy
Device: Non-invasive positive pressure ventilation
use of high flow nasal cannula to support oxygenation and CO2 removal by flushing the nasopharynx with warmed, humidified respiratory gas at flow rates that exceed a patient's inspiratory flow rate
Also known as: high flow nasal cannula
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.
Institution of positive pressure ventilation (PPV) or non-invasive positive pressure ventilation (NIPPV)
Time frame: While in Emergency Department; at 24 hrs
Borg Dyspnea Scale
Time frame: 0, 2, 4 hrs
Respiratory Rate
Time frame: 0, 2, 4 hrs
Arterial blood chemistry including pH, pCO2, pO2, HCO3-, BE-
Time frame: 0, 2, 4 hrs
Pulse Ox and FIO2
Time frame: 0, 2, 4 hrs
Intensive Care Unit admission rate / Length of Stay
Time frame: 7 days
Hospital Length of Stay
Time frame: 7 days
Total duration of NIPPV/PPV or Vapotherm oxygen delivery
Time frame: 7 days
Integrated FIO2 exposure
Time frame: 7 days
Physician assessment - retractions, physician judgment of patient discomfort
Time frame: 0, 2, 4 hrs
This study is withdrawn, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Vapotherm, Inc.