IntelliCycleTM 2.0 Improved Patient-ventilator Asynchrony During PSV

Study Overview
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Brief Summary
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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
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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.

Official Title
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Automatic Adjustmen of Inspiratory Triger and Cycling-off Based on Waveform Improved Patient-ventilator Interation During Pressure Support Ventilation

Conditions
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Automatic Adjustmen of Inspiratory Triger and Cycling-off

Intervention / Treatment
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* Device: automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: PSV-10%<br>PSV mode using E5 ventilator with fixed flow trigger and Esense 10% | Device: automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence<br>* The ventilators have a compunter drived funcation of automatic adjustmen of inspiratory triger and cycling-off based on waveform, IntelliCycleTM 2.0.<br>|
| Placebo Comparator: PVS-30%<br>PSV mode using E5 ventilator with fixed flow trigger and Esense 30% | Device: automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence<br>* The ventilators have a compunter drived funcation of automatic adjustmen of inspiratory triger and cycling-off based on waveform, IntelliCycleTM 2.0.<br>|
| Placebo Comparator: PSV-50%<br>PSV mode using E5 ventilator with fixed flow trigger and Esense 50% | Device: automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence<br>* The ventilators have a compunter drived funcation of automatic adjustmen of inspiratory triger and cycling-off based on waveform, IntelliCycleTM 2.0.<br>|
| Experimental: PSV-auto<br>PSV mode using automatic adjustmen of inspiratory triger and cycling-off based on waveform | Device: automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence<br>* The ventilators have a compunter drived funcation of automatic adjustmen of inspiratory triger and cycling-off based on waveform, IntelliCycleTM 2.0.<br>|
| Active Comparator: PSV-neuro<br>NAVA mode using NAVA level of 15 cmH2O/uV and pressure limit function to simulated EAdi triggered PSV. | Device: automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence<br>* The ventilators have a compunter drived funcation of automatic adjustmen of inspiratory triger and cycling-off based on waveform, IntelliCycleTM 2.0.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asynchrony Index | number of asynchrony events divided by the total neural respiratory rate | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Respiratory Patterns | Patient Respiratory Patterns during Pressure Support Ventilation | 20 minutes | 
| gas exchange | Patient gas exchange during Pressure Support Ventilation | 20 minutes | 
| work of breathing | work of triggering and respiratory in different arms | 20 minutes | 
| other patient-ventilator synchrony parameters | trigger and cycle-off asynchrony, Ineffective efforts, double triggering, auto-triggering, premature cycling and late cycling | 20minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient-ventilator interation, automatic adjustmen of inspiratory triger and cycling-off, Neurally controlled PS