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

Not Applicable

Withdrawn

• Conditions: Respiratory Insufficiency; Pulmonary Disease, Chronic Obstructive
• Interventions: Device: Vapotherm High Flow Therapy; Device: Non-invasive positive pressure ventilation

• Registration Number: NCT00990119
• Lead Sponsor: Vapotherm, Inc.

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.

Study Timeline

• Study First Submitted: 2009-08-27
• Study Start: 2009-09
• Study First Submitted QC: 2009-10-02
• Study First Posted: 2009-10-06
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High FLow Therapy	Vapotherm High Flow Therapy	Use of High Flow Therapy for support of Respiratory Insufficiency
NiPPV	Non-invasive positive pressure ventilation	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States