Acute Respiratory Distress SyndromeNCT02867228
Noninvasive Estimation of Work of Breathing
A study testing changes in ventilator settings in people with Acute Respiratory Distress Syndrome, run by Respironics, California, Inc. at 1 site in United States.
Trial summary
This study will evaluate the correlation between invasively measured parameters (work of breathing/power of breathing, resistance and elastance), derived using esophageal pressure measurements, and their corresponding non-invasive estimated values (noninvasive work of breathing/power of breathing, resistance and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- changes in ventilator settings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 4 May 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult medical/surgical ICU patients (Age≥18) on mechanical ventilation for respiratory failure, spontaneously breathing and receiving eligible for pressure support ventilation (PSV).
Who cannot join
- Prisoners and patients with closed-head injury (e.g., trauma), hemodynamic instability, multiple organ system failure or late term pregnancy will not be studied.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
This study will evaluate the correlation between invasively measured parameters (work of breathing/power of breathing, resistance and elastance), derived using esophageal pressure measurements, and their corresponding non-invasive estimated values (noninvasive work of breathing/power of breathing, resistance and elastance), computed using airway pressure and flow measurements only.
Read the detailed description
This study will evaluate the correlation between invasively measured parameters (work of breathing/power of breathing, resistance and elastance), derived using esophageal pressure measurements, and their corresponding non-invasive estimated values (noninvasive work of breathing/power of breathing, resistance and elastance), computed using airway pressure and flow measurements only. Vent settings will be adjusted to test accuracy over a range of respiratory support conditions.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- changes in ventilator settings
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
changes in ventilator settingsOther
Ventilator settings will be adjusted (vent mode, pressure support/control level, cycling, inspiratory time, mandatory rate).
| Study group | Role | What they receive |
|---|---|---|
| Single Observational Group | Other | Patients receiving mechanical ventilation and subject to the intervention: changes in ventilator settings. Receives: Other: changes in ventilator settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of lung mechanics measurements
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startSep 2016
- Primary completion4 May 2017
- Study completion4 May 2017
Why it stopped: Resources to be able to screen and enroll patients are no longer available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respironics, California, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David H Chong, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867228
- Sponsor's protocol ID
- IRB-AAAP8801
- Status last verified
- Aug 2016
- First submitted
- 10 Aug 2016
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Banner MJ, Kirby RR, Kirton OC, DeHaven CB, Blanch PB. Breathing frequency and pattern are poor predictors of work of breathing in patients receiving pressure support ventilation. Chest. 1995 Nov;108(5):1338-44. doi: 10.1378/chest.108.5.1338.
PubMed 7587438Kirton OC, DeHaven CB, Hudson-Civetta J, Morgan JP, Windsor J, Civetta JM. Re-engineering ventilatory support to decrease days and improve resource utilization. Ann Surg. 1996 Sep;224(3):396-402; discussion 402-4. doi: 10.1097/00000658-199609000-00016.
PubMed 8813268
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Estimation of Work of Breathing
- ClinicalTrials.gov ID
- NCT02867228
- Acronym / sponsor ID
- IRB-AAAP8801
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Resources to be able to screen and enroll patients are no longer available.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Respironics, California, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- 4 May 2017 (actual)
- Study completion
- 4 May 2017 (actual)
- First posted
- 15 Aug 2016 (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.
This study will evaluate the correlation between invasively measured parameters (work of breathing/power of breathing, resistance and elastance), derived using esophageal pressure measurements, and their corresponding non-invasive estimated values (noninvasive work of breathing/power of breathing, resistance and elastance), computed using airway pressure and flow measurements only.
Detailed description
This study will evaluate the correlation between invasively measured parameters (work of breathing/power of breathing, resistance and elastance), derived using esophageal pressure measurements, and their corresponding non-invasive estimated values (noninvasive work of breathing/power of breathing, resistance and elastance), computed using airway pressure and flow measurements only. Vent settings will be adjusted to test accuracy over a range of respiratory support conditions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Observational Group | Other | Other: changes in ventilator settingsPatients receiving mechanical ventilation and subject to the intervention: changes in ventilator settings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult medical/surgical ICU patients (Age≥18) on mechanical ventilation for respiratory failure, spontaneously breathing and receiving eligible for pressure support ventilation (PSV).
Key exclusion criteria (1 listed)
- Prisoners and patients with closed-head injury (e.g., trauma), hemodynamic instability, multiple organ system failure or late term pregnancy will not be studied.
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 |
|---|---|---|
| changes in ventilator settingsVentilator settings will be adjusted (vent mode, pressure support/control level, cycling, inspiratory time, mandatory rate). | Other | Single Observational Group |
Primary outcome
Accuracy of lung mechanics measurements
Time frame: Immediate
Results and safety
The study was stopped early (reason given: Resources to be able to screen and enroll patients are no longer available.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Results publication: PubMed 7587438Banner MJ, Kirby RR, Kirton OC, DeHaven CB, Blanch PB. Breathing frequency and pattern are poor predictors of work of breathing in patients receiving pressure support ventilation. Chest. 1995 Nov;108(5):1338-44. doi: 10.1378/chest.108.5.1338.
- Results publication: PubMed 8813268Kirton OC, DeHaven CB, Hudson-Civetta J, Morgan JP, Windsor J, Civetta JM. Re-engineering ventilatory support to decrease days and improve resource utilization. Ann Surg. 1996 Sep;224(3):396-402; discussion 402-4. doi: 10.1097/00000658-199609000-00016.
- Individual participant dataSharing planned: No
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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.
David H Chong, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing changes in ventilator settings in people with Acute Respiratory Distress Syndrome, run by Respironics, California, 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 27 Jul 2017. 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 stopped early (reason given: Resources to be able to screen and enroll patients are no longer available.). Results are not available in the source record.
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?
Accuracy of lung mechanics measurements (time frame: Immediate). 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 NCT02867228, which also lists 2 linked publications.
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 27 Jul 2017.