IntelliCycleTM 2.0 Improved Patient-ventilator Asynchrony During PSV

Not Applicable

Completed

• Conditions: Automatic Adjustmen of Inspiratory Triger and Cycling-off
• Interventions: Device: automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence

• Registration Number: NCT04091269
• Lead Sponsor: Southeast University, China

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.

Study Timeline

• Study First Submitted: 2019-09-11
• Study First Submitted QC: 2019-09-12
• Study First Posted: 2019-09-16
• Study Start: 2019-09-18
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-25
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PSV-auto	automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence	PSV mode using automatic adjustmen of inspiratory triger and cycling-off based on waveform
PVS-30%	automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence	PSV mode using E5 ventilator with fixed flow trigger and Esense 30%
PSV-10%	automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence	PSV mode using E5 ventilator with fixed flow trigger and Esense 10%
PSV-50%	automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence	PSV mode using E5 ventilator with fixed flow trigger and Esense 50%
PSV-neuro	automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence	NAVA mode using NAVA level of 15 cmH2O/uV and pressure limit function to simulated EAdi triggered PSV.

Primary Outcome Measures

Name	Time	Method
Asynchrony Index	20 minutes	number of asynchrony events divided by the total neural respiratory rate

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ling Liu; 🇨🇳 Nanjing, Jiangsu, China