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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00990119
Other study ID # CRP-2009-03
Secondary ID Temple IRB proto
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 2009
Est. completion date April 2014

Study information

Verified date September 2020
Source Vapotherm, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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
Non-invasive positive pressure ventilation
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.

Locations

Country Name City State
United States Temple University Hospital Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Vapotherm, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Institution of positive pressure ventilation (PPV) or non-invasive positive pressure ventilation (NIPPV) While in Emergency Department; at 24 hrs
Secondary Borg Dyspnea Scale 0, 2, 4 hrs
Secondary Respiratory Rate 0, 2, 4 hrs
Secondary Arterial blood chemistry including pH, pCO2, pO2, HCO3-, BE- 0, 2, 4 hrs
Secondary Pulse Ox and FIO2 0, 2, 4 hrs
Secondary Intensive Care Unit admission rate / Length of Stay 7 days
Secondary Hospital Length of Stay 7 days
Secondary Total duration of NIPPV/PPV or Vapotherm oxygen delivery 7 days
Secondary Integrated FIO2 exposure 7 days
Secondary Physician assessment - retractions, physician judgment of patient discomfort 0, 2, 4 hrs
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