Acute Respiratory Distress SyndromeNCT02881385
Effects on Respiratory Patterns and Patient-ventilator Synchrony Using Pressure Support Ventilation
An observational study of Acute Respiratory Distress Syndrome and COPD, run by Southeast University, China.
Trial summary
Pressure Support Ventilation use Expiratory triggering sensitivity(Esense) to transfer inspiration to expiration,the value of Esense is fixed.That may lead to asynchrony between humans and ventilators,making people uncomfortable and prolonging weaning time.Some ventilators have auto cycle function Based on curves of… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome, COPD, Post Operative
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Aug 2017
- 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: mechanical ventilation adult people using PSV mode in ICU
Who may be able to join
- ARDS,COPD and Postoperative patient
Who cannot join
- variety of reasons can not be placed next to the bed by the nasal EAdi catheter
About this study
Official title: Effects on Respiratory Patterns and Patient-ventilator Synchrony in Different Ventilator Using Pressure Support Ventilation
Pressure Support Ventilation use Expiratory triggering sensitivity(Esense) to transfer inspiration to expiration,the value of Esense is fixed.That may lead to asynchrony between humans and ventilators,making people uncomfortable and prolonging weaning time.Some ventilators have auto cycle function Based on curves of pressure on respiratory patterns,it will make the transforming more synchrony with humans.Our prospective observational study will prove the superiority of the auto cycle function.
Read the detailed description
From August 31st 2016 to August 31st 2017, all ARDS 、COPD and postoperative patients admitted to the ICUs will be enrolled. The demographic characteristics, diagnosis, formerly medical history, Ventilator indications, Ventilator data, other respiratory treatments, weaning outcome and 28 day mortality will be recorded
- Conditions
- Acute Respiratory Distress Syndrome, COPD, Post Operative
- Keywords
- Synchrony, Pressure Support Ventilation
- Medical subject headings
- Respiratory Distress Syndrome, Pulmonary Disease, Chronic Obstructive
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 |
|---|---|---|
| E5 Esense 10% | PSV mode using E5 ventilator with Esense 10% | |
| E5 Esense 30% | PSV mode using E5 ventilator with Esense 30% | |
| E5 Esense 50% | PSV mode using E5 ventilator with Esense 50% | |
| Servo-I Esense 10% | PSV mode using Servo-I ventilator with Esense 10% | |
| Servo-I Esense 30% | PSV mode using Servo-I ventilator with Esense 30% | |
| Servo-I Esense 50% | PSV mode using Servo-I ventilator with Esense 50% | |
| E5 Esense autocycle | PSV mode using E5 ventilator with Esense Auto cycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient-ventilator synchrony using PSV mode between different ventilator for 180mins
Measured: 180mins after the patients involved
Secondary outcomes (4)
Patient Respiratory Patterns during Pressure Support Ventilation for 180mins
Measured: 180mins
Patient gas exchange during Pressure Support Ventilation for 180mins
Measured: 180mins
Effects on Respiratory Patterns in different Expiratory triggering sensitivity for 180mins
Measured: 180mins
work of triggering and respiratory in different Expiratory triggering sensitivity for 180mins
Measured: 180mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Pan, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881385
- Sponsor's protocol ID
- zhongdayiyuanICU
- Status last verified
- Sep 2016
- First submitted
- 30 Jul 2016
- Last updated
- 13 Sep 2016
- 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 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Respiratory Patterns and Patient-ventilator Synchrony in Different Ventilator Using Pressure Support Ventilation
- ClinicalTrials.gov ID
- NCT02881385
- Acronym / sponsor ID
- zhongdayiyuanICU
- Conditions
- Acute Respiratory Distress Syndrome, COPD, Post Operative
- Keywords
- Synchrony, Pressure Support Ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 29 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.
Pressure Support Ventilation use Expiratory triggering sensitivity(Esense) to transfer inspiration to expiration,the value of Esense is fixed.That may lead to asynchrony between humans and ventilators,making people uncomfortable and prolonging weaning time.Some ventilators have auto cycle function Based on curves of pressure on respiratory patterns,it will make the transforming more synchrony with humans.Our prospective observational study will prove the superiority of the auto cycle function.
Detailed description
From August 31st 2016 to August 31st 2017, all ARDS 、COPD and postoperative patients admitted to the ICUs will be enrolled. The demographic characteristics, diagnosis, formerly medical history, Ventilator indications, Ventilator data, other respiratory treatments, weaning outcome and 28 day mortality will be recorded
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| E5 Esense 10% | – | –PSV mode using E5 ventilator with Esense 10% |
| E5 Esense 30% | – | –PSV mode using E5 ventilator with Esense 30% |
| E5 Esense 50% | – | –PSV mode using E5 ventilator with Esense 50% |
| Servo-I Esense 10% | – | –PSV mode using Servo-I ventilator with Esense 10% |
| Servo-I Esense 30% | – | –PSV mode using Servo-I ventilator with Esense 30% |
| Servo-I Esense 50% | – | –PSV mode using Servo-I ventilator with Esense 50% |
| E5 Esense autocycle | – | –PSV mode using E5 ventilator with Esense Auto cycle |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- mechanical ventilation adult people using PSV mode in ICU
Key inclusion criteria (1 listed)
- ARDS,COPD and Postoperative patient
Key exclusion criteria (1 listed)
- variety of reasons can not be placed next to the bed by the nasal EAdi catheter
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
patient-ventilator synchrony using PSV mode between different ventilator for 180mins
Time frame: 180mins after the patients involved
4 secondary outcomes
Patient Respiratory Patterns during Pressure Support Ventilation for 180mins
Time frame: 180mins
Patient gas exchange during Pressure Support Ventilation for 180mins
Time frame: 180mins
Effects on Respiratory Patterns in different Expiratory triggering sensitivity for 180mins
Time frame: 180mins
work of triggering and respiratory in different Expiratory triggering sensitivity for 180mins
Time frame: 180mins
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome and COPD, run by Southeast University, 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 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: status not confirmed, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
patient-ventilator synchrony using PSV mode between different ventilator for 180mins (time frame: 180mins after the patients involved). 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 13 Sep 2016.