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

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ClinicalTrials.gov Identifier: NCT00990119
Recruitment Status : Suspended
First Posted : October 6, 2009
Last Update Posted : February 27, 2014
Sponsor:
Information provided by (Responsible Party):
Vapotherm, Inc.

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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Respiratory Insufficiency Device: Vapotherm High Flow Therapy Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vapotherm High Flow Therapy Via Nasal Cannula to Treat Respiratory Insufficiency in Patients With Chronic Obstructive Pulmonary Disease
Study Start Date : September 2009
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: High FLow Therapy
Use of High Flow Therapy for support of Respiratory Insufficiency
Device: Vapotherm High Flow Therapy
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
Other Name: high flow nasal cannula



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

Secondary Outcome Measures :
  1. Borg Dyspnea Scale [ Time Frame: 0, 2, 4 hrs ]
  2. Respiratory Rate [ Time Frame: 0, 2, 4 hrs ]
  3. Arterial blood chemistry including pH, pCO2, pO2, HCO3-, BE- [ Time Frame: 0, 2, 4 hrs ]
  4. Pulse Ox and FIO2 [ Time Frame: 0, 2, 4 hrs ]
  5. Intensive Care Unit admission rate / Length of Stay [ Time Frame: 7 days ]
  6. Hospital Length of Stay [ Time Frame: 7 days ]
  7. Total duration of NIPPV/PPV or Vapotherm oxygen delivery [ Time Frame: 7 days ]
  8. Integrated FIO2 exposure [ Time Frame: 7 days ]
  9. Physician assessment - retractions, physician judgment of patient discomfort [ Time Frame: 0, 2, 4 hrs ]


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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Present to the Emergency Department with a history of COPD and with symptoms consistent with a diagnosis of respiratory insufficiency and exacerbation of COPD
  • Must be hemodynamically stable as judged by treating clinician in the ED
  • Primary complaint is shortness of breath, and presumed diagnosis is exacerbation of COPD

Exclusion Criteria:

  • Fever
  • Radiographic evidence of pneumonia
  • Glasgow Coma score < 14 or unable to correctly answer at least one study-specific question

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): NCT00990119


Locations
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Vapotherm, Inc.
Investigators
Principal Investigator: Marla R Wolfson, PhD Temple University
Principal Investigator: Nina Gentile, MD Temple University Hospital

Publications:
Responsible Party: Vapotherm, Inc.
ClinicalTrials.gov Identifier: NCT00990119     History of Changes
Other Study ID Numbers: CRP-2009-03
Temple IRB protocol # 12573
First Posted: October 6, 2009    Key Record Dates
Last Update Posted: February 27, 2014
Last Verified: February 2014

Keywords provided by Vapotherm, Inc.:
high flow therapy
high flow nasal cannula
chronic obstructive pulmonary disease
respiratory insufficiency

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Respiration Disorders
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases