High-flow Nasal CannulaNCT04245241
Effects of High-Flow Nasal Cannula Therapy Assessed by Electrical Impedance Tomography
An observational study of High-flow Nasal Cannula and Electrical Impedance Tomography, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study aimed to determine the effects of HFNC therapy on lung recruitment and lung strain change assessed by electrical impedance tomography (EIT) Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- High-flow Nasal Cannula, Electrical Impedance Tomography
- What is being tested?
- High-flow nasal cannula (HFNC)
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 1 Nov 2019
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult critically ill patients, who received a HENC therapy within 24 h after the extubation, were enrolled.
Who may be able to join
- Patient who received a HENC therapy within 24 h after the extubation
Who cannot join
- Aged <18 years
- Pregnancy
- Body mass index (BMI) over 50 kg/m2
- ribcage malformation .any contraindication of using EIT monitoring (automatic implantable cardioverter defibrillator, chest skin injury, etc.).
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences,
Beijing, Beijing Municipality, 100730
About this study
Official title: Effects of High-Flow Nasal Cannula Therapy on Lung Recruitment and Lung Strain Change Assessed by Electrical Impedance Tomography
This study aimed to determine the effects of HFNC therapy on lung recruitment and lung strain change assessed by electrical impedance tomography (EIT)
- Being tested
- High-flow nasal cannula (HFNC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow nasal cannula (HFNC)Other
24 patients who receiving HFNC within 24 hours after extubation were prospectively enrolled in this study. EIT was used to monitor regional lung ventilation distributions at baseline (conventional oxygen therapy) and three flow rate levels of HFNC therapy (20, 40 and 60 L/min).
What is being measured
The primary outcome is the main question the study is designed to answer.
lung regional ventilation distribution
lung regional ventilation distribution measured by EIT
Measured: minute 80
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 May 2018
- Primary completion1 Jul 2019
- Study completion1 Nov 2019
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 High-flow Nasal CannulaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245241
- Sponsor's protocol ID
- EIT-HFNC
- Status last verified
- Jan 2020
- First submitted
- 20 Jan 2020
- Last updated
- 28 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang R, He H, Yun L, Zhou X, Wang X, Chi Y, Yuan S, Zhao Z. Effect of postextubation high-flow nasal cannula therapy on lung recruitment and overdistension in high-risk patient. Crit Care. 2020 Mar 6;24(1):82. doi: 10.1186/s13054-020-2809-7.
PubMed 32143664
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-Flow Nasal Cannula Therapy on Lung Recruitment and Lung Strain Change Assessed by Electrical Impedance Tomography
- ClinicalTrials.gov ID
- NCT04245241
- Acronym / sponsor ID
- EIT-HFNC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 28 Jan 2020 (actual)
- 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 aimed to determine the effects of HFNC therapy on lung recruitment and lung strain change assessed by electrical impedance tomography (EIT)
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult critically ill patients, who received a HENC therapy within 24 h after the extubation, were enrolled.
Key inclusion criteria (1 listed)
- Patient who received a HENC therapy within 24 h after the extubation
Key exclusion criteria (4 listed)
- Aged <18 years
- Pregnancy
- Body mass index (BMI) over 50 kg/m2
- ribcage malformation .any contraindication of using EIT monitoring (automatic implantable cardioverter defibrillator, chest skin injury, etc.).
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 |
|---|---|---|
| High-flow nasal cannula (HFNC)24 patients who receiving HFNC within 24 hours after extubation were prospectively enrolled in this study. EIT was used to monitor regional lung ventilation distributions at baseline (conventional oxygen therapy) and three flow rate levels of HFNC therapy (20, 40 and 60 L/min). | Other | – |
Primary outcome
lung regional ventilation distribution
Time frame: minute 80
lung regional ventilation distribution measured by EIT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Derived from this study: PubMed 32143664Zhang R, He H, Yun L, Zhou X, Wang X, Chi Y, Yuan S, Zhao Z. Effect of postextubation high-flow nasal cannula therapy on lung recruitment and overdistension in high-risk patient. Crit Care. 2020 Mar 6;24(1):82. doi: 10.1186/s13054-020-2809-7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High-flow Nasal Cannula and Electrical Impedance Tomography, run by Peking Union Medical College Hospital at 1 site in China.
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 4 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: finished, as of the sponsor's last update on 28 Jan 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
lung regional ventilation distribution (time frame: minute 80). 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 NCT04245241, 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 28 Jan 2020.