Pulmonary Disease, Chronic ObstructiveNCT00990119
High Flow Therapy (HFT) to Treat Respiratory Insufficiency in Chronic Obstructive Pulmonary Disease (COPD)
A study testing Vapotherm High Flow Therapy and Non-invasive positive pressure ventilation in people with Pulmonary Disease, Chronic Obstructive and Respiratory Insufficiency, run by Vapotherm, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency
- What is being tested?
- Vapotherm High Flow Therapy and Non-invasive positive pressure ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Fever
- Radiographic evidence of pneumonia
- Glasgow Coma score < 14 or unable to correctly answer at least one study-specific question
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University Hospital
Philadelphia, Pennsylvania, 19140
About this study
Official title: 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.
Read the 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.
- Being tested
- Vapotherm High Flow Therapy, Non-invasive positive pressure ventilation
- Keywords
- high flow therapy, high flow nasal cannula, chronic obstructive pulmonary disease, respiratory insufficiency
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vapotherm High Flow TherapyDevice
Also called high flow nasal cannula
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
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.
| Study group | Role | What they receive |
|---|---|---|
| High FLow Therapy | Experimental | Use of High Flow Therapy for support of Respiratory Insufficiency Receives: Device: Vapotherm High Flow Therapy |
| NiPPV | Active comparator | Not described Receives: Device: Non-invasive positive pressure ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Institution of positive pressure ventilation (PPV) or non-invasive positive pressure ventilation (NIPPV)
Measured: While in Emergency Department; at 24 hrs
Secondary outcomes (9)
Borg Dyspnea Scale
Measured: 0, 2, 4 hrs
Respiratory Rate
Measured: 0, 2, 4 hrs
Arterial blood chemistry including pH, pCO2, pO2, HCO3-, BE-
Measured: 0, 2, 4 hrs
Pulse Ox and FIO2
Measured: 0, 2, 4 hrs
Intensive Care Unit admission rate / Length of Stay
Measured: 7 days
Hospital Length of Stay
Measured: 7 days
Total duration of NIPPV/PPV or Vapotherm oxygen delivery
Measured: 7 days
Integrated FIO2 exposure
Measured: 7 days
Physician assessment - retractions, physician judgment of patient discomfort
Measured: 0, 2, 4 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: Pilot enrollment criteria did not yield intended population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vapotherm, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marla R Wolfson, PhD, Principal investigator, Temple UniversityNina Gentile, MD, Principal investigator, Temple University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990119
- Sponsor's protocol ID
- CRP-2009-03
- Other IDs
- Temple IRB protocol # 12573
- Status last verified
- Sep 2020
- First submitted
- 27 Aug 2009
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19467849
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vapotherm High Flow Therapy Via Nasal Cannula to Treat Respiratory Insufficiency in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00990119
- Acronym / sponsor ID
- CRP-2009-03
- Keywords
- high flow therapy, high flow nasal cannula, chronic obstructive pulmonary disease, respiratory insufficiency
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Pilot enrollment criteria did not yield intended population.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vapotherm, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 6 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High FLow Therapy | Experimental | Device: Vapotherm High Flow TherapyUse of High Flow Therapy for support of Respiratory Insufficiency |
| NiPPV | Active comparator | Device: Non-invasive positive pressure ventilation |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Fever
- Radiographic evidence of pneumonia
- Glasgow Coma score < 14 or unable to correctly answer at least one study-specific question
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vapotherm High Flow TherapyAlso: high flow nasal cannulause 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 | Device | High FLow Therapy |
| Non-invasive positive pressure ventilationPatients 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. | Device | NiPPV |
Primary outcome
Institution of positive pressure ventilation (PPV) or non-invasive positive pressure ventilation (NIPPV)
Time frame: While in Emergency Department; at 24 hrs
9 secondary outcomes
Borg Dyspnea Scale
Time frame: 0, 2, 4 hrs
Respiratory Rate
Time frame: 0, 2, 4 hrs
Arterial blood chemistry including pH, pCO2, pO2, HCO3-, BE-
Time frame: 0, 2, 4 hrs
Pulse Ox and FIO2
Time frame: 0, 2, 4 hrs
Intensive Care Unit admission rate / Length of Stay
Time frame: 7 days
Hospital Length of Stay
Time frame: 7 days
Total duration of NIPPV/PPV or Vapotherm oxygen delivery
Time frame: 7 days
Integrated FIO2 exposure
Time frame: 7 days
Physician assessment - retractions, physician judgment of patient discomfort
Time frame: 0, 2, 4 hrs
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Background: PubMed 19467849Dysart 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marla R Wolfson, PhD principal investigator
Temple University
Nina Gentile, MD principal investigator
Temple University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vapotherm High Flow Therapy and Non-invasive positive pressure ventilation in people with Pulmonary Disease, Chronic Obstructive and Respiratory Insufficiency, run by Vapotherm, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Institution of positive pressure ventilation (PPV) or non-invasive positive pressure ventilation (NIPPV) (time frame: While in Emergency Department; at 24 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00990119, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.