Critical IllnessNCT04081129
Effect of Early Mobilization on Regional Lung Ventilation Assessed by EIT
An observational study of Critical Illness and Lung Function Decreased, run by Yun Long at 1 site in China.
Trial summary
Changes in pulmonary ventilation and perfusion by EIT to out-of-bed activity in critically ill patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Lung Function Decreased, ICU Acquired Weakness
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients was performed out-of-bed activity, who were sequentially admitted to the ICU
Who may be able to join
- adult patients was performed out-of-bed activity in the ICU department based on doctor order
- Age (> 18 years old) and (< 90 years old)
Who cannot join
- Chest skin is injury and cannot be monitored by EIT
- The patients or their families refused to participate in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Yun Long, 13911608699, ly_icu@aliyun.com
Siyi Yuan, 15201518815, yuansiyizqh@163.com
About this study
Official title: Using EIT to Assess the Effect of Early Mobilization on Regional Lung Ventilation in ICU Patients
Changes in pulmonary ventilation and perfusion by EIT to out-of-bed activity in critically ill patients
Read the detailed description
- EIT measurements were performed in ICU patients who under out-of-bed activity
- Measurement of EIT was taken place at 4 time points: supine position before early mobilization, 30min, 60min during early mobilization, supine positon after early mobilization. All of them were without invasive ventilation. Measurements were made in triplicate at all time points.
- Keywords
- EIT, early mobilization
- Medical subject headings
- Critical Illness, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICU patients with early mobilization | Not described |
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 was measured by EIT
Measured: Hour 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
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 Critical IllnessStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yun Long
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yun Long, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081129
- Sponsor's protocol ID
- EIT-early mobilization
- Status last verified
- Sep 2019
- First submitted
- 3 Sep 2019
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yuan S, Chi Y, Long Y, He H, Zhao Z. Effect of Position Change From the Bed to a Wheelchair on the Regional Ventilation Distribution Assessed by Electrical Impedance Tomography in Patients With Respiratory Failure. Front Med (Lausanne). 2021 Nov 4;8:744958. doi: 10.3389/fmed.2021.744958. eCollection 2021.
PubMed 34805212
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using EIT to Assess the Effect of Early Mobilization on Regional Lung Ventilation in ICU Patients
- ClinicalTrials.gov ID
- NCT04081129
- Acronym / sponsor ID
- EIT-early mobilization
- Keywords
- EIT, early mobilization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yun LongUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 9 Sep 2019 (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.
Changes in pulmonary ventilation and perfusion by EIT to out-of-bed activity in critically ill patients
Detailed description
- EIT measurements were performed in ICU patients who under out-of-bed activity
- Measurement of EIT was taken place at 4 time points: supine position before early mobilization, 30min, 60min during early mobilization, supine positon after early mobilization. All of them were without invasive ventilation. Measurements were made in triplicate at all time points.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients with early mobilization | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients was performed out-of-bed activity, who were sequentially admitted to the ICU
Key inclusion criteria (2 listed)
- adult patients was performed out-of-bed activity in the ICU department based on doctor order
- Age (> 18 years old) and (< 90 years old)
Key exclusion criteria (2 listed)
- Chest skin is injury and cannot be monitored by EIT
- The patients or their families refused to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
lung regional ventilation distribution
Time frame: Hour 1
lung regional ventilation distribution was measured by EIT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Derived from this study: PubMed 34805212Yuan S, Chi Y, Long Y, He H, Zhao Z. Effect of Position Change From the Bed to a Wheelchair on the Regional Ventilation Distribution Assessed by Electrical Impedance Tomography in Patients With Respiratory Failure. Front Med (Lausanne). 2021 Nov 4;8:744958. doi: 10.3389/fmed.2021.744958. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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.
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 Critical Illness and Lung Function Decreased, run by Yun Long 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 2 inclusion and 2 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 10 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun Long (13911608699, ly_icu@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lung regional ventilation distribution (time frame: Hour 1). 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 NCT04081129, 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 10 Sep 2019.