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

V

Vapotherm

Status

Withdrawn

Conditions

Respiratory Insufficiency
Pulmonary Disease, Chronic Obstructive

Treatments

Device: Non-invasive positive pressure ventilation
Device: Vapotherm High Flow Therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT00990119
CRP-2009-03
Temple IRB protocol # 12573

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

50+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

High FLow Therapy
Experimental group
Description:
Use of High Flow Therapy for support of Respiratory Insufficiency
Treatment:
Device: Vapotherm High Flow Therapy
NiPPV
Active Comparator group
Treatment:
Device: Non-invasive positive pressure ventilation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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