ICU(Intensive Care Unit) PatientsNCT02998294
Respiratory Volume Measure Using ExSpiron 1Xi
A study testing Respiratory Volume Monitor(RVM) and artificial respirator in people with ICU(Intensive Care Unit) Patients and Mechanical Ventilation After Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study was to determine the accuracy of one-time respiratory volume measured by RVM(Respiratory Volume Monitor) compared to the one-time respiratory volume measured by mechanical ventilation in post-operative ICU patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- ICU(Intensive Care Unit) Patients, Mechanical Ventilation After Surgery
- What is being tested?
- Respiratory Volume Monitor(RVM) and artificial respirator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Apr 2016to 15 Feb 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An adult patients ( ≥ age 19)
- patients who receive mechanical ventilation in the ICU of the Severance Hospital after surgery and plans to wean the mechanical ventilation within 3 days.
Who cannot join
- severe respiratory illness patients (pneumothorax, chest tube intubation status, severe restrictive respiratory disease, unilateral lung ventilation, lung transplantation status, chronic restrictive respiratory disease, hydrothorax, diaphragmatic movement disorder)
- If the candidate can not understand and carry out the experiment contents and process
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 03722
About this study
The purpose of this study was to determine the accuracy of one-time respiratory volume measured by RVM(Respiratory Volume Monitor) compared to the one-time respiratory volume measured by mechanical ventilation in post-operative ICU patients.
Read the detailed description
The purpose of this study was to determine the accuracy of one-time respiratory volume measured by RVM(Respiratory Volume Monitor) compared to the one-time respiratory volume measured by mechanical ventilation in post-operative ICU patients.
In addition, the investigators investigated the decrease in respiratory volume in opioid infusion after ventilator weaning in this patient, and to measure the one-time respiratory volume change by RVM during deep breathing induction using Inspirometry exercise.
- Being tested
- Respiratory Volume Monitor(RVM), artificial respirator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Volume Monitor(RVM)Device
Also called ExSpiron™ 1Xi
The purpose of this study was to determine the accuracy of one-time respiratory volume measured by RVM compared to the one-time respiratory volume measured by mechanical ventilation in post-operative ICU patients.
artificial respiratorDevice
The purpose of this study was to determine the accuracy of one-time respiratory volume measured by RVM compared to the one-time respiratory volume measured by mechanical ventilation in post-operative ICU patients.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory monitoring group | Experimental | Not described Receives: Device: Respiratory Volume Monitor(RVM); Device: artificial respirator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory volume measure using ExSpiron 1Xi
During mechanical ventilator, we obtained respiratory parameter from ventilator and also we collected same parameter via RVM.
Measured: during 10-minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start6 Apr 2016
- Primary completion15 Feb 2017
- Study completion15 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU(Intensive Care Unit) PatientsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998294
- Sponsor's protocol ID
- 1-2016-0008
- Status last verified
- Jul 2018
- First submitted
- 13 Dec 2016
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Volume Measure Using ExSpiron 1Xi
- ClinicalTrials.gov ID
- NCT02998294
- Acronym / sponsor ID
- 1-2016-0008
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 6 Apr 2016 (actual)
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 15 Feb 2017 (actual)
- First posted
- 20 Dec 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.
The purpose of this study was to determine the accuracy of one-time respiratory volume measured by RVM(Respiratory Volume Monitor) compared to the one-time respiratory volume measured by mechanical ventilation in post-operative ICU patients.
Detailed description
The purpose of this study was to determine the accuracy of one-time respiratory volume measured by RVM(Respiratory Volume Monitor) compared to the one-time respiratory volume measured by mechanical ventilation in post-operative ICU patients.
In addition, the investigators investigated the decrease in respiratory volume in opioid infusion after ventilator weaning in this patient, and to measure the one-time respiratory volume change by RVM during deep breathing induction using Inspirometry exercise.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiratory monitoring group | Experimental | Device: Respiratory Volume Monitor(RVM), Device: artificial respirator |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- An adult patients ( ≥ age 19)
- patients who receive mechanical ventilation in the ICU of the Severance Hospital after surgery and plans to wean the mechanical ventilation within 3 days.
Key exclusion criteria (2 listed)
- severe respiratory illness patients (pneumothorax, chest tube intubation status, severe restrictive respiratory disease, unilateral lung ventilation, lung transplantation status, chronic restrictive respiratory disease, hydrothorax, diaphragmatic movement disorder)
- If the candidate can not understand and carry out the experiment contents and process
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 |
|---|---|---|
| Respiratory Volume Monitor(RVM)Also: ExSpiron™ 1XiThe purpose of this study was to determine the accuracy of one-time respiratory volume measured by RVM compared to the one-time respiratory volume measured by mechanical ventilation in post-operative ICU patients. | Device | Respiratory monitoring group |
| artificial respiratorThe purpose of this study was to determine the accuracy of one-time respiratory volume measured by RVM compared to the one-time respiratory volume measured by mechanical ventilation in post-operative ICU patients. | Device | Respiratory monitoring group |
Primary outcome
Respiratory volume measure using ExSpiron 1Xi
Time frame: during 10-minute
During mechanical ventilator, we obtained respiratory parameter from ventilator and also we collected same parameter via RVM.
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 18 Jul 2018.
- 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.
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?
A study testing Respiratory Volume Monitor(RVM) and artificial respirator in people with ICU(Intensive Care Unit) Patients and Mechanical Ventilation After Surgery, run by Yonsei University at 1 site in South Korea.
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: finished, as of the sponsor's last update on 18 Jul 2018. 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 South Korea. 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?
Respiratory volume measure using ExSpiron 1Xi (time frame: during 10-minute). 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 18 Jul 2018.