Back to resultsIntelliCycleTM 2.0 Improved Patient-ventilator Asynchrony During PSV
Primary Purpose
Automatic Adjustmen of Inspiratory Triger and Cycling-off
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence
Sponsored by
About this trial
This is an interventional supportive care trial for Automatic Adjustmen of Inspiratory Triger and Cycling-off focused on measuring patient-ventilator interation, automatic adjustmen of inspiratory triger and cycling-off, Neurally controlled PS
Eligibility Criteria
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.
Sites / Locations
- Ling Liu
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Placebo Comparator
Placebo Comparator
Placebo Comparator
Experimental
Active Comparator
Arm Label
PSV-10%
PVS-30%
PSV-50%
PSV-auto
PSV-neuro
Arm Description
PSV mode using E5 ventilator with fixed flow trigger and Esense 10%
PSV mode using E5 ventilator with fixed flow trigger and Esense 30%
PSV mode using E5 ventilator with fixed flow trigger and Esense 50%
PSV mode using automatic adjustmen of inspiratory triger and cycling-off based on waveform
NAVA mode using NAVA level of 15 cmH2O/uV and pressure limit function to simulated EAdi triggered PSV.
Outcomes
Primary Outcome Measures
Asynchrony Index
number of asynchrony events divided by the total neural respiratory rate
Secondary Outcome Measures
Patient Respiratory Patterns
Patient Respiratory Patterns during Pressure Support Ventilation
gas exchange
Patient gas exchange during Pressure Support Ventilation
work of breathing
work of triggering and respiratory in different arms
other patient-ventilator synchrony parameters
trigger and cycle-off asynchrony, Ineffective efforts, double triggering, auto-triggering, premature cycling and late cycling
Full Information
NCT ID
NCT04091269
First Posted
September 11, 2019
Last Updated
July 25, 2021
Sponsor
Southeast University, China
1. Study Identification
Unique Protocol Identification Number
NCT04091269
Brief Title
IntelliCycleTM 2.0 Improved Patient-ventilator Asynchrony During PSV
Official Title
Automatic Adjustmen of Inspiratory Triger and Cycling-off Based on Waveform Improved Patient-ventilator Interation During Pressure Support Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 18, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Automatic Adjustmen of Inspiratory Triger and Cycling-off
Keywords
patient-ventilator interation, automatic adjustmen of inspiratory triger and cycling-off, Neurally controlled PS
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PSV-10%
Arm Type
Placebo Comparator
Arm Description
PSV mode using E5 ventilator with fixed flow trigger and Esense 10%
Arm Title
PVS-30%
Arm Type
Placebo Comparator
Arm Description
PSV mode using E5 ventilator with fixed flow trigger and Esense 30%
Arm Title
PSV-50%
Arm Type
Placebo Comparator
Arm Description
PSV mode using E5 ventilator with fixed flow trigger and Esense 50%
Arm Title
PSV-auto
Arm Type
Experimental
Arm Description
PSV mode using automatic adjustmen of inspiratory triger and cycling-off based on waveform
Arm Title
PSV-neuro
Arm Type
Active Comparator
Arm Description
NAVA mode using NAVA level of 15 cmH2O/uV and pressure limit function to simulated EAdi triggered PSV.
Intervention Type
Device
Intervention Name(s)
automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence
Intervention Description
The ventilators have a compunter drived funcation of automatic adjustmen of inspiratory triger and cycling-off based on waveform, IntelliCycleTM 2.0.
Primary Outcome Measure Information:
Title
Asynchrony Index
Description
number of asynchrony events divided by the total neural respiratory rate
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Patient Respiratory Patterns
Description
Patient Respiratory Patterns during Pressure Support Ventilation
Time Frame
20 minutes
Title
gas exchange
Description
Patient gas exchange during Pressure Support Ventilation
Time Frame
20 minutes
Title
work of breathing
Description
work of triggering and respiratory in different arms
Time Frame
20 minutes
Title
other patient-ventilator synchrony parameters
Description
trigger and cycle-off asynchrony, Ineffective efforts, double triggering, auto-triggering, premature cycling and late cycling
Time Frame
20minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ling Liu
Organizational Affiliation
Zhongda Hospital, School of Medicine, Southeast University,
Official's Role
Study Director
Facility Information:
Facility Name
Ling Liu
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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IntelliCycleTM 2.0 Improved Patient-ventilator Asynchrony During PSV
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