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

NCT ID: NCT00990119

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2014-04-30

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.

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High FLow Therapy

Use of High Flow Therapy for support of Respiratory Insufficiency

Group Type: EXPERIMENTAL

Vapotherm High Flow Therapy

Intervention Type: DEVICE

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

NiPPV

Group Type: ACTIVE_COMPARATOR

Non-invasive positive pressure ventilation

Intervention Type: DEVICE

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.

Interventions

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

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Other Intervention Names

high flow nasal cannula

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vapotherm, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marla R Wolfson, PhD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Nina Gentile, MD

Role: PRINCIPAL_INVESTIGATOR

Temple University Hospital

Locations

Temple University Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19467849 (View on PubMed)

Other Identifiers

Temple IRB protocol # 12573

Identifier Type: -

Identifier Source: secondary_id

CRP-2009-03

Identifier Type: -

Identifier Source: org_study_id