Clinical trial NCT00990119: High Flow Therapy (HFT) to Treat Respiratory Insufficiency in Chronic Obstructive Pulmonary Disease (COPD)
Official title: Vapotherm High Flow Therapy Via Nasal Cannula to Treat Respiratory Insufficiency in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Respiratory Insufficiency
Keywords: high flow therapy
high flow nasal cannula
chronic obstructive pulmonary disease
respiratory insufficiency
Lead sponsor: Vapotherm, Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-06
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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

Primary outcomes:
measure: Institution of positive pressure ventilation (PPV) or non-invasive positive pressure ventilation (NIPPV)
timeFrame: While in Emergency Department; at 24 hrs
Secondary outcomes:
measure: Borg Dyspnea Scale
timeFrame: 0, 2, 4 hrs
measure: Respiratory Rate
timeFrame: 0, 2, 4 hrs
measure: Arterial blood chemistry including pH, pCO2, pO2, HCO3-, BE-
timeFrame: 0, 2, 4 hrs
measure: Pulse Ox and FIO2
timeFrame: 0, 2, 4 hrs
measure: Intensive Care Unit admission rate / Length of Stay
timeFrame: 7 days
measure: Hospital Length of Stay
timeFrame: 7 days
measure: Total duration of NIPPV/PPV or Vapotherm oxygen delivery
timeFrame: 7 days
measure: Integrated FIO2 exposure
timeFrame: 7 days
measure: Physician assessment - retractions, physician judgment of patient discomfort
timeFrame: 0, 2, 4 hrs
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Marla R Wolfson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Temple University Hospital
name: Nina Gentile, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dysart K, Miller TL, Wolfson MR, Shaffer TH. Research in high flow therapy: mechanisms of action. Respir Med. 2009 Oct;103(10):1400-5. doi: 10.1016/j.rmed.2009.04.007. Epub 2009 May 21.