Clinical Trial: High Flow Therapy (HFT) to Treat Respiratory Insufficiency in Chronic Obstructive Pulmonary Disease (COPD)

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: Vapotherm High Flow Therapy Via Nasal Cannula to Treat Respiratory Insufficiency in Patients With Chronic Obstructive Pulmonary Disease

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Vapotherm, Inc.

Current Primary Outcome: Institution of positive pressure ventilation (PPV) or non-invasive positive pressure ventilation (NIPPV) [ Time Frame: While in Emergency Department; at 24 hrs ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Vapotherm, Inc.

Dates:
Date Received: August 27, 2009
Date Started: September 2009
Date Completion: April 2014
Last Updated: February 26, 2014
Last Verified: February 2014