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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Vapotherm, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Vapotherm, Inc.
ClinicalTrials.gov Identifier:
NCT00990119
First received: August 27, 2009
Last updated: June 6, 2011
Last verified: October 2009
History of Changes
  Purpose

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 Intervention
Pulmonary Disease, Chronic Obstructive
Respiratory Insufficiency
 Device: Vapotherm High Flow Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vapotherm, Inc.:

Primary Outcome Measures:
  • Institution of positive pressure ventilation (PPV) or non-invasive positive pressure ventilation (NIPPV) [ Time Frame: While in Emergency Department; at 24 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Borg Dyspnea Scale [ Time Frame: 0, 2, 4 hrs ] [ Designated as safety issue: No ]
  • Respiratory Rate [ Time Frame: 0, 2, 4 hrs ] [ Designated as safety issue: No ]
  • Arterial blood chemistry including pH, pCO2, pO2, HCO3-, BE- [ Time Frame: 0, 2, 4 hrs ] [ Designated as safety issue: No ]
  • Pulse Ox and FIO2 [ Time Frame: 0, 2, 4 hrs ] [ Designated as safety issue: No ]
  • Intensive Care Unit admission rate / Length of Stay [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Hospital Length of Stay [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Total duration of NIPPV/PPV or Vapotherm oxygen delivery [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Integrated FIO2 exposure [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Physician assessment - retractions, physician judgment of patient discomfort [ Time Frame: 0, 2, 4 hrs ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990119

Contacts
Contact: Marla R Wolfson, PhD 215-707-4573 marla.wolfson@temple.edu
Contact: Nina Gentile, MD (215) 707-8402 ngentile@temple.edu

Locations
United States, Pennsylvania
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Marla R Wolfson, PhD     215-707-4573     marla.wolfson@temple.edu    
Principal Investigator: Nina Gentile, MD            
Sub-Investigator: Jacob Ufberg, MD            
Sponsors and Collaborators
Vapotherm, Inc.
Investigators
Principal Investigator: Marla R Wolfson, PhD Temple University
Principal Investigator: Nina Gentile, MD Temple University Hospital
  More Information

Publications:

Responsible Party: Thomas L. Miller, PhD, Director of Research and Education, Vapotherm, Inc.
ClinicalTrials.gov Identifier: NCT00990119     History of Changes
Other Study ID Numbers: CRP-2009-03, Temple IRB protocol # 12573
Study First Received: August 27, 2009
Last Updated: June 6, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 16, 2013