NCT00990119

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 6, 2009

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

4.6 years

First QC Date

August 27, 2009

Last Update Submit

September 14, 2020

Conditions

Pulmonary Disease, Chronic ObstructiveRespiratory Insufficiency

Keywords

high flow therapyhigh flow nasal cannulachronic obstructive pulmonary diseaserespiratory insufficiency

Outcome Measures

Primary Outcomes (1)

  • Institution of positive pressure ventilation (PPV) or non-invasive positive pressure ventilation (NIPPV)

    While in Emergency Department; at 24 hrs

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

High FLow Therapy

EXPERIMENTAL

Use of High Flow Therapy for support of Respiratory Insufficiency

Device: Vapotherm High Flow Therapy

NiPPV

ACTIVE COMPARATOR
Device: Non-invasive positive pressure ventilation

Interventions

Vapotherm High Flow TherapyDEVICE

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

Also known as: high flow nasal cannula
High FLow Therapy
Non-invasive positive pressure ventilationDEVICE

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.

NiPPV

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Fever
  • Radiographic evidence of pneumonia
  • Glasgow Coma score \< 14 or unable to correctly answer at least one study-specific question

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (1)

  • 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.

    PMID: 19467849BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration Disorders

Study Officials

  • Marla R Wolfson, PhD

    Temple University

    PRINCIPAL INVESTIGATOR

  • Nina Gentile, MD

    Temple University Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2009

First Posted

October 6, 2009

Study Start

September 1, 2009

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations

US(1)