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IntelliCycleTM 2.0 Improved Patient-ventilator Asynchrony During PSV

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04091269
Enrollment
24
Registered
2019-09-16
Start date
2019-09-18
Completion date
2019-12-31
Last updated
2021-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Automatic Adjustmen of Inspiratory Triger and Cycling-off

Keywords

patient-ventilator interation, automatic adjustmen of inspiratory triger and cycling-off, Neurally controlled PS

Brief 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. 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.

Interventions

DEVICEautomatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence

The ventilators have a compunter drived funcation of automatic adjustmen of inspiratory triger and cycling-off based on waveform, IntelliCycleTM 2.0.

Sponsors

Southeast University, China
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

PSV+ Automatic adjustmen of inspiratory triger and cycling-off based on waveform PSV with fixed inspiratory and expiratory NAVA

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

Postoperation patients 1. receiving invasive mechanical ventilation due to operation 2. abdominal surgery, orthopedic surgery or gynecological surgery 3. without respiratory system Comorbidity 4. able to sustain PSV more than 1 h with inspiratory support ≤ 15 cmH2O. COPD and ARDS patients 1. receiving invasive mechanical ventilation due to acute respiratory failure 2. able to sustain PSV more than 1 h with inspiratory support ≤ 15 cmH2O.

Exclusion criteria

1. age \< 18 or \>85 years, 2. tracheostomy at time of inclusion, 3. 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), 4. neuromuscular disease affecting spontaneous breathing (e.g. history of acute central or peripheral nervous system disorder or neuromuscular disease with irregular spontaneous rhythm), 5. 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), 6. sedation level Richmond Agitation-Sedation Scale (RASS) ≤ -2 or ≥ 2, 7. lack of informed consent and patients included in other intervention study.

Design outcomes

Primary

MeasureTime frameDescription
Asynchrony Index20 minutesnumber of asynchrony events divided by the total neural respiratory rate

Secondary

MeasureTime frameDescription
Patient Respiratory Patterns20 minutesPatient Respiratory Patterns during Pressure Support Ventilation
gas exchange20 minutesPatient gas exchange during Pressure Support Ventilation
work of breathing20 minuteswork of triggering and respiratory in different arms
other patient-ventilator synchrony parameters20minutestrigger and cycle-off asynchrony, Ineffective efforts, double triggering, auto-triggering, premature cycling and late cycling

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026