Back to results

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

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vapotherm High Flow Therapy

Non-invasive positive pressure ventilation

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring high flow therapy, high flow nasal cannula, chronic obstructive pulmonary disease, respiratory insufficiency

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Temple University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High FLow Therapy

NiPPV

Arm Description

Use of High Flow Therapy for support of Respiratory Insufficiency

Outcomes

Primary Outcome Measures

Institution of positive pressure ventilation (PPV) or non-invasive positive pressure ventilation (NIPPV)

Secondary Outcome Measures

Borg Dyspnea Scale

Respiratory Rate

Arterial blood chemistry including pH, pCO2, pO2, HCO3-, BE-

Pulse Ox and FIO2

Intensive Care Unit admission rate / Length of Stay

Hospital Length of Stay

Total duration of NIPPV/PPV or Vapotherm oxygen delivery

Integrated FIO2 exposure

Physician assessment - retractions, physician judgment of patient discomfort

Full Information

NCT ID

NCT00990119

First Posted

August 27, 2009

Last Updated

September 14, 2020

Sponsor

Vapotherm, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00990119

Brief Title

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

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Withdrawn

Why Stopped

Pilot enrollment criteria did not yield intended population.

Study Start Date

September 2009 (Actual)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vapotherm, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency

Keywords

high flow therapy, high flow nasal cannula, chronic obstructive pulmonary disease, respiratory insufficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High FLow Therapy

Arm Type

Experimental

Arm Description

Use of High Flow Therapy for support of Respiratory Insufficiency

Arm Title

NiPPV

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Vapotherm High Flow Therapy

Other Intervention Name(s)

high flow nasal cannula

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Non-invasive positive pressure ventilation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Institution of positive pressure ventilation (PPV) or non-invasive positive pressure ventilation (NIPPV)

Time Frame

While in Emergency Department; at 24 hrs

Secondary Outcome Measure Information:

Title

Borg Dyspnea Scale

Time Frame

0, 2, 4 hrs

Title

Respiratory Rate

Time Frame

0, 2, 4 hrs

Title

Arterial blood chemistry including pH, pCO2, pO2, HCO3-, BE-

Time Frame

0, 2, 4 hrs

Title

Pulse Ox and FIO2

Time Frame

0, 2, 4 hrs

Title

Intensive Care Unit admission rate / Length of Stay

Time Frame

7 days

Title

Hospital Length of Stay

Time Frame

7 days

Title

Total duration of NIPPV/PPV or Vapotherm oxygen delivery

Time Frame

7 days

Title

Integrated FIO2 exposure

Time Frame

7 days

Title

Physician assessment - retractions, physician judgment of patient discomfort

Time Frame

0, 2, 4 hrs

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marla R Wolfson, PhD

Organizational Affiliation

Temple University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Nina Gentile, MD

Organizational Affiliation

Temple University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Temple University Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19467849

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.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs