Automatic Adjustmen of Inspiratory Triger and Cycling-offNCT04091269
IntelliCycleTM 2.0 Improved Patient-ventilator Asynchrony During PSV
A study testing automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence in people with Automatic Adjustmen of Inspiratory Triger and Cycling-off, run by Southeast University, China at 1 site in 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Automatic Adjustmen of Inspiratory Triger and Cycling-off
- What is being tested?
- automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 18 Sep 2019to 31 Dec 2019
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postoperation patients
- receiving invasive mechanical ventilation due to operation
- abdominal surgery, orthopedic surgery or gynecological surgery
- without respiratory system Comorbidity
- able to sustain PSV more than 1 h with inspiratory support ≤ 15 cmH2O.
- COPD and ARDS patients
- receiving invasive mechanical ventilation due to acute respiratory failure
- able to sustain PSV more than 1 h with inspiratory support ≤ 15 cmH2O.
Who cannot join
- age < 18 or >85 years,
- tracheostomy at time of inclusion,
- contra-indication for nasogastric tube insertion (e.g. history of esophageal varices, gastro-esophageal surgery in the previous 12 months or gastro-esophageal bleeding in the previous 7 days, INR ratio > 1.5 , APTT > 44 s, history of leukemia),
- neuromuscular disease affecting spontaneous breathing (e.g. history of acute central or peripheral nervous system disorder or neuromuscular disease with irregular spontaneous rhythm),
- hemodynamic unstable (heart rate > 140 beats/min, vasopressors required with ≥ 5 μg.kg-1.min-1 dopamine/ dobutamine, or ≥ 0.2 μg.kg-1.min-1 norepinephrine),
- sedation level Richmond Agitation-Sedation Scale (RASS) ≤ -2 or ≥ 2,
- lack of informed consent and patients included in other intervention study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Automatic Adjustmen of Inspiratory Triger and Cycling-off Based on Waveform Improved Patient-ventilator Interation During 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. Furthermore，trigger delay or inffective trigger happens frequently during insppiratory triggering. The ventilators have a compunter drived funcation of automatic adjustmen of inspiratory triger and cycling-off based on waveform, IntelliCycleTM 2.0. It will make the transforming more synchrony with humans. The objectibe of the present study is to detect the effect of automatic adjustmen of inspiratory triger and cycling-off based on waveform on patient-ventilator interation.
Read the detailed description
This is a physiological cross-over study. Enrolled patient with different baseline respiratory mechanics, for example ARDS patients with low compliance, COPD patient with high airway resistance and postoperative patients with almost normal compliance and airway resistance. Patients are ventilated with PSV+ Automatic adjustmen of inspiratory triger and cycling-off based on waveform, PSV with fixed inspiratory and expiratory and NAVA in two different levels of support. The demographic characteristics, diagnosis, formerly medical history, Ventilator indications, Ventilator data, other respiratory treatments, patient-ventilator interation, work of breathing, Eadi, will be recorded.
- Being tested
- automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence
- Keywords
- patient-ventilator interation, automatic adjustmen of inspiratory triger and cycling-off, Neurally controlled PS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed EsenceDevice
The ventilators have a compunter drived funcation of automatic adjustmen of inspiratory triger and cycling-off based on waveform, IntelliCycleTM 2.0.
| Study group | Role | What they receive |
|---|---|---|
| PSV-10% | Placebo comparator | PSV mode using E5 ventilator with fixed flow trigger and Esense 10% Receives: Device: automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence |
| PVS-30% | Placebo comparator | PSV mode using E5 ventilator with fixed flow trigger and Esense 30% Receives: Device: automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence |
| PSV-50% | Placebo comparator | PSV mode using E5 ventilator with fixed flow trigger and Esense 50% Receives: Device: automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence |
| PSV-auto | Experimental | PSV mode using automatic adjustmen of inspiratory triger and cycling-off based on waveform Receives: Device: automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence |
| PSV-neuro | Active comparator | NAVA mode using NAVA level of 15 cmH2O/uV and pressure limit function to simulated EAdi triggered PSV. Receives: Device: automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asynchrony Index
number of asynchrony events divided by the total neural respiratory rate
Measured: 20 minutes
Secondary outcomes (4)
Patient Respiratory Patterns
Patient Respiratory Patterns during Pressure Support Ventilation
Measured: 20 minutes
gas exchange
Patient gas exchange during Pressure Support Ventilation
Measured: 20 minutes
work of breathing
work of triggering and respiratory in different arms
Measured: 20 minutes
other patient-ventilator synchrony parameters
trigger and cycle-off asynchrony, Ineffective efforts, double triggering, auto-triggering, premature cycling and late cycling
Measured: 20minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start18 Sep 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Automatic Adjustmen of Inspiratory Triger and Cycling-offStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- PSV+ Automatic adjustmen of inspiratory triger and cycling-off based on waveform PSV with fixed inspiratory and expiratory NAVA
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
- Investigators
- Ling Liu, Study director, Zhongda Hospital, School of Medicine, Southeast University,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091269
- Sponsor's protocol ID
- ZDSYLL067-P01
- Status last verified
- Jul 2021
- First submitted
- 11 Sep 2019
- Last updated
- 28 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Adjustmen of Inspiratory Triger and Cycling-off Based on Waveform Improved Patient-ventilator Interation During Pressure Support Ventilation
- ClinicalTrials.gov ID
- NCT04091269
- Acronym / sponsor ID
- ZDSYLL067-P01
- Keywords
- patient-ventilator interation, automatic adjustmen of inspiratory triger and cycling-off, Neurally controlled PS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 16 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.
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. Furthermore，trigger delay or inffective trigger happens frequently during insppiratory triggering. The ventilators have a compunter drived funcation of automatic adjustmen of inspiratory triger and cycling-off based on waveform, IntelliCycleTM 2.0. It will make the transforming more synchrony with humans. The objectibe of the present study is to detect the effect of automatic adjustmen of inspiratory triger and cycling-off based on waveform on patient-ventilator interation.
Detailed description
This is a physiological cross-over study. Enrolled patient with different baseline respiratory mechanics, for example ARDS patients with low compliance, COPD patient with high airway resistance and postoperative patients with almost normal compliance and airway resistance. Patients are ventilated with PSV+ Automatic adjustmen of inspiratory triger and cycling-off based on waveform, PSV with fixed inspiratory and expiratory and NAVA in two different levels of support. The demographic characteristics, diagnosis, formerly medical history, Ventilator indications, Ventilator data, other respiratory treatments, patient-ventilator interation, work of breathing, Eadi, will be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- PSV+ Automatic adjustmen of inspiratory triger and cycling-off based on waveform PSV with fixed inspiratory and expiratory NAVA
| Arm | Type | Receives |
|---|---|---|
| PSV-10% | Placebo comparator | Device: automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed EsencePSV mode using E5 ventilator with fixed flow trigger and Esense 10% |
| PVS-30% | Placebo comparator | Device: automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed EsencePSV mode using E5 ventilator with fixed flow trigger and Esense 30% |
| PSV-50% | Placebo comparator | Device: automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed EsencePSV mode using E5 ventilator with fixed flow trigger and Esense 50% |
| PSV-auto | Experimental | Device: automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed EsencePSV mode using automatic adjustmen of inspiratory triger and cycling-off based on waveform |
| PSV-neuro | Active comparator | Device: automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed EsenceNAVA mode using NAVA level of 15 cmH2O/uV and pressure limit function to simulated EAdi triggered PSV. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Postoperation patients
- receiving invasive mechanical ventilation due to operation
- abdominal surgery, orthopedic surgery or gynecological surgery
- without respiratory system Comorbidity
- able to sustain PSV more than 1 h with inspiratory support ≤ 15 cmH2O.
Key exclusion criteria (7 listed)
- age < 18 or >85 years,
- tracheostomy at time of inclusion,
- contra-indication for nasogastric tube insertion (e.g. history of esophageal varices, gastro-esophageal surgery in the previous 12 months or gastro-esophageal bleeding in the previous 7 days, INR ratio > 1.5 , APTT > 44 s, history of leukemia),
- neuromuscular disease affecting spontaneous breathing (e.g. history of acute central or peripheral nervous system disorder or neuromuscular disease with irregular spontaneous rhythm),
- hemodynamic unstable (heart rate > 140 beats/min, vasopressors required with ≥ 5 μg.kg-1.min-1 dopamine/ dobutamine, or ≥ 0.2 μg.kg-1.min-1 norepinephrine),
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 |
|---|---|---|
| automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed EsenceThe ventilators have a compunter drived funcation of automatic adjustmen of inspiratory triger and cycling-off based on waveform, IntelliCycleTM 2.0. | Device | PSV-10%, PSV-50%, PSV-auto, PSV-neuro, PVS-30% |
Primary outcome
Asynchrony Index
Time frame: 20 minutes
number of asynchrony events divided by the total neural respiratory rate
4 secondary outcomes
Patient Respiratory Patterns
Time frame: 20 minutes
gas exchange
Time frame: 20 minutes
work of breathing
Time frame: 20 minutes
other patient-ventilator synchrony parameters
Time frame: 20minutes
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 Jul 2021.
- Individual participant dataSharing planned: Undecided
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.
Ling Liu study director
Zhongda Hospital, School of Medicine, Southeast University,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence in people with Automatic Adjustmen of Inspiratory Triger and Cycling-off, run by Southeast University, China 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 8 inclusion and 7 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 Jul 2021. 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. Some participants in this study may receive a placebo. 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?
Asynchrony Index (time frame: 20 minutes). 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 28 Jul 2021.