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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency
• Intervention / Treatment: Device: Vapotherm High Flow Therapy; Device: Non-invasive positive pressure ventilation

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High FLow Therapy; Use of High Flow Therapy for support of Respiratory Insufficiency	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; Other Names: high flow nasal cannula
Active Comparator: NiPPV	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Institution of positive pressure ventilation (PPV) or non-invasive positive pressure ventilation (NIPPV)	While in Emergency Department; at 24 hrs

Secondary Outcome Measures

Outcome Measure	Time Frame
Borg Dyspnea Scale	0, 2, 4 hrs
Respiratory Rate	0, 2, 4 hrs
Arterial blood chemistry including pH, pCO2, pO2, HCO3-, BE-	0, 2, 4 hrs
Pulse Ox and FIO2	0, 2, 4 hrs
Intensive Care Unit admission rate / Length of Stay	7 days
Hospital Length of Stay	7 days
Total duration of NIPPV/PPV or Vapotherm oxygen delivery	7 days
Integrated FIO2 exposure	7 days
Physician assessment - retractions, physician judgment of patient discomfort	0, 2, 4 hrs

Collaborators and Investigators

• Sponsor: Vapotherm, Inc.
• Investigators: Principal Investigator: Marla R Wolfson, PhD, Temple University; Principal Investigator: Nina Gentile, MD, Temple University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2009
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: August 27, 2009
• First Submitted That Met QC Criteria: October 2, 2009
• First Posted (Estimate): October 6, 2009

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: respiratory insufficiency; high flow nasal cannula; chronic obstructive pulmonary disease; high flow therapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency
• Other Study ID Numbers: CRP-2009-03; Temple IRB protocol # 12573