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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn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• Status: Withdrawn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
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

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