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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Ling Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: PSV-10%; 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; The ventilators have a compunter drived funcation of automatic adjustmen of inspiratory triger and cycling-off based on waveform, IntelliCycleTM 2.0.
PLACEBO_COMPARATOR: PVS-30%; 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; The ventilators have a compunter drived funcation of automatic adjustmen of inspiratory triger and cycling-off based on waveform, IntelliCycleTM 2.0.
PLACEBO_COMPARATOR: PSV-50%; 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; The ventilators have a compunter drived funcation of automatic adjustmen of inspiratory triger and cycling-off based on waveform, IntelliCycleTM 2.0.
EXPERIMENTAL: PSV-auto; 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; The ventilators have a compunter drived funcation of automatic adjustmen of inspiratory triger and cycling-off based on waveform, IntelliCycleTM 2.0.
ACTIVE_COMPARATOR: PSV-neuro; 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; The ventilators have a compunter drived funcation of automatic adjustmen of inspiratory triger and cycling-off based on waveform, IntelliCycleTM 2.0.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Southeast University, China
• Investigators: Study Director: Ling Liu, Zhongda Hospital, School of Medicine, Southeast University,

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 18, 2019
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (ACTUAL): September 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 25, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: patient-ventilator interation; automatic adjustmen of inspiratory triger and cycling-off; Neurally controlled PS
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: ZDSYLL067-P01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No