Respiratory FailureNCT02292992
Lung Volume Change Between Noninvasive Positive Pressure Ventilation by Nasal Pillow and High Flow Nasal Cannula
A study testing Nasal Pillow CPAP in people with Respiratory Failure, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
The difference of lung volume change will be monitored by electrical impedance tomography before and after use of noninvasive positive pressure ventilation by nasal pillow and high flow nasal cannula in post-extubation patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Nasal Pillow CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2014to Oct 2015
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >20 y/o
- Any extubated patients after tolerating spontaneous breathing trial
Who cannot join
- Presence of tracheostomy
- Recent facial trauma
- Active gastro-intestinal bleeding
- Do-not-intubate status and
- Planned use of BiPAP after extubation.
- Patients with unstable spinal lesions or fractures.
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- BMI> 50
- Patients with a cardiac pacemaker
- Burn injury with skin defect
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Mackay Memorial Hospital
Taipei
Kuo Li Kuo, MD
About this study
Official title: The Difference of Lung Volume Change Detected by Electrical Impedance Tomography (EIT) Between Noninvasive Positive-pressure Ventilation (NIPPV) Support by Nasal Pillow and High Flow Nasal Cannula in Post-extubation Patients
The difference of lung volume change will be monitored by electrical impedance tomography before and after use of noninvasive positive pressure ventilation by nasal pillow and high flow nasal cannula in post-extubation patients.
Read the detailed description
Electrical impedance tomography can effectively monitor the lung volume change in ICU patients who were under mechanical ventilator or noninvasive positive pressure ventilator support. Continuous positive airway pressure (CPAP) support by nasal pillow and high flow nasal cannula can improve inspiratory function in extubated patients . However, the extent of lung volume change or functional residual volume (FRC) change by using these two devices were never surveyed before in extubated patients. The investigators will check end-expiratory lung volume (EELV) ,anterior, medio-anterior, medio-posterior and posterior EELV by electrical impedance tomography after use of these two devices in extubated patients.
- Conditions
- Respiratory Failure
- Being tested
- Nasal Pillow CPAP
- Keywords
- Electrical impedance tomography, Nasal Pillow Continuous Positive Airway Pressure(CPAP), High Flow Nasal Cannula, extubation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal Pillow CPAPDevice
Nasal Pillow CPAP in extubated patients
| Study group | Role | What they receive |
|---|---|---|
| Nasal pillow CPAP | Experimental | Nasal pillow CPAP Receives: Device: Nasal Pillow CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
• End-expiratory lung volume (EELV) determined by electrical impedance tomography after high flow nasal cannula and nasal pillow CPAP
Measured: at day 1
Secondary outcomes (1)
Anterior, medio-anterior, medio-posterior and posterior EELV at each time
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lee Chao-Hsien, MD, Principal investigator, +886975835770 l49428@mmh.org.tw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292992
- Sponsor's protocol ID
- 14MMHIS167
- Status last verified
- Dec 2014
- First submitted
- 27 Oct 2014
- Last updated
- 15 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Difference of Lung Volume Change Detected by Electrical Impedance Tomography (EIT) Between Noninvasive Positive-pressure Ventilation (NIPPV) Support by Nasal Pillow and High Flow Nasal Cannula in Post-extubation Patients
- ClinicalTrials.gov ID
- NCT02292992
- Acronym / sponsor ID
- 14MMHIS167
- Conditions
- Respiratory Failure
- Keywords
- Electrical impedance tomography, Nasal Pillow Continuous Positive Airway Pressure(CPAP), High Flow Nasal Cannula, extubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 18 Nov 2014 (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 difference of lung volume change will be monitored by electrical impedance tomography before and after use of noninvasive positive pressure ventilation by nasal pillow and high flow nasal cannula in post-extubation patients.
Detailed description
Electrical impedance tomography can effectively monitor the lung volume change in ICU patients who were under mechanical ventilator or noninvasive positive pressure ventilator support. Continuous positive airway pressure (CPAP) support by nasal pillow and high flow nasal cannula can improve inspiratory function in extubated patients . However, the extent of lung volume change or functional residual volume (FRC) change by using these two devices were never surveyed before in extubated patients. The investigators will check end-expiratory lung volume (EELV) ,anterior, medio-anterior, medio-posterior and posterior EELV by electrical impedance tomography after use of these two devices in extubated patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasal pillow CPAP | Experimental | Device: Nasal Pillow CPAPNasal pillow CPAP |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >20 y/o
- Any extubated patients after tolerating spontaneous breathing trial
Key exclusion criteria (9 listed)
- Presence of tracheostomy
- Recent facial trauma
- Active gastro-intestinal bleeding
- Do-not-intubate status and
- Planned use of BiPAP after extubation.
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 |
|---|---|---|
| Nasal Pillow CPAPNasal Pillow CPAP in extubated patients | Device | Nasal pillow CPAP |
Primary outcome
• End-expiratory lung volume (EELV) determined by electrical impedance tomography after high flow nasal cannula and nasal pillow CPAP
Time frame: at day 1
1 secondary outcome
Anterior, medio-anterior, medio-posterior and posterior EELV at each time
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2014.
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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.
Lee Chao-Hsien, MD principal investigator
+886975835770 l49428@mmh.org.tw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal Pillow CPAP in people with Respiratory Failure, run by Mackay Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 15 Dec 2014. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kuo Li Kuo, MD (+886975835135, lmn4093@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• End-expiratory lung volume (EELV) determined by electrical impedance tomography after high flow nasal cannula and nasal pillow CPAP (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2014.