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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency

Intervention / Treatment
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* Device: Vapotherm High Flow Therapy
* Device: Non-invasive positive pressure ventilation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High FLow Therapy<br>Use of High Flow Therapy for support of Respiratory Insufficiency | Device: Vapotherm High Flow Therapy<br>* 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<br>* Other names: high flow nasal cannula;|
| Active Comparator: NiPPV<br> | Device: Non-invasive positive pressure ventilation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high flow therapy, high flow nasal cannula, chronic obstructive pulmonary disease, respiratory insufficiency