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IntelliCycleTM 2.0 Improved Patient-ventilator Asynchrony During PSV

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ClinicalTrials.gov Identifier: NCT04091269
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Ling Liu, 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.

Condition or disease Intervention/treatment Phase
Automatic Adjustmen of Inspiratory Triger and Cycling-off Device: automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: Automatic Adjustmen of Inspiratory Triger and Cycling-off Based on Waveform Improved Patient-ventilator Interation During Pressure Support Ventilation
Estimated Study Start Date : September 18, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 30, 2020

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.




Primary Outcome Measures :
  1. Cycle-off error [ Time Frame: 20 minutes ]
    cycle-off asynchrony form EAdi and ventilator


Secondary Outcome Measures :
  1. Patient Respiratory Patterns [ Time Frame: 20 minutes ]
    Patient Respiratory Patterns during Pressure Support Ventilation

  2. gas exchange [ Time Frame: 20 minutes ]
    Patient gas exchange during Pressure Support Ventilation

  3. work of breathing [ Time Frame: 20 minutes ]
    work of triggering and respiratory in different arms

  4. other patient-ventilator synchrony parameters [ Time Frame: 20minutes ]
    trigger and cycle-off asynchrony, Ineffective efforts, double triggering, auto-triggering, premature cycling and late cycling



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091269


Contacts
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Contact: Yue Yu +8613851435472 ext +8613851435472 liulingdoctor@126.com
Contact: Xiaoting Xu +8613645188041 ext +8613645188041 xuxiaoting2005@163.com

Sponsors and Collaborators
Southeast University, China
Investigators
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Study Director: Ling Liu Zhongda Hospital, School of Medicine, Southeast University,

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Responsible Party: Ling Liu, Principal Investigator, Southeast University, China
ClinicalTrials.gov Identifier: NCT04091269     History of Changes
Other Study ID Numbers: ZDSYLL067-P01
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ling Liu, Southeast University, China:
patient-ventilator interation
automatic adjustmen of inspiratory triger and cycling-off
NAVA
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes