IntelliCycleTM 2.0 Improved Patient-ventilator Asynchrony During PSV

NCT ID: NCT04091269

Last Updated: 2021-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-18

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Automatic Adjustmen of Inspiratory Triger and Cycling-off

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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PSV-10%

PSV mode using E5 ventilator with fixed flow trigger and Esense 10%

Group Type PLACEBO_COMPARATOR

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

Intervention Type DEVICE

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

PVS-30%

PSV mode using E5 ventilator with fixed flow trigger and Esense 30%

Group Type PLACEBO_COMPARATOR

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

Intervention Type DEVICE

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

PSV-50%

PSV mode using E5 ventilator with fixed flow trigger and Esense 50%

Group Type PLACEBO_COMPARATOR

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

Intervention Type DEVICE

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

PSV-auto

PSV mode using automatic adjustmen of inspiratory triger and cycling-off based on waveform

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

PSV-neuro

NAVA mode using NAVA level of 15 cmH2O/uV and pressure limit function to simulated EAdi triggered PSV.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southeast University, China

OTHER

Sponsor Role lead

Responsible Party

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Ling Liu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ling Liu

Role: STUDY_DIRECTOR

Zhongda Hospital, School of Medicine, Southeast University,

Locations

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Ling Liu

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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ZDSYLL067-P01

Identifier Type: -

Identifier Source: org_study_id

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