IntelliCycleTM 2.0 Improved Patient-ventilator Asynchrony During PSV

Automatic Adjustmen of Inspiratory Triger and Cycling-off Clinical Trial

Official title:

Automatic Adjustmen of Inspiratory Triger and Cycling-off Based on Waveform Improved Patient-ventilator Interation During Pressure Support Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04091269
• Other study ID #: ZDSYLL067-P01
• Status: Completed
• Phase: N/A
• Start date: September 18, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2021
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Automatic Adjustmen of Inspiratory Triger and Cycling-off
• Respiratory Aspiration

Intervention

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.

Locations

Country	Name	City	State
China	Ling Liu	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asynchrony Index	number of asynchrony events divided by the total neural respiratory rate	20 minutes
Secondary	Patient Respiratory Patterns	Patient Respiratory Patterns during Pressure Support Ventilation	20 minutes
Secondary	gas exchange	Patient gas exchange during Pressure Support Ventilation	20 minutes
Secondary	work of breathing	work of triggering and respiratory in different arms	20 minutes
Secondary	other patient-ventilator synchrony parameters	trigger and cycle-off asynchrony, Ineffective efforts, double triggering, auto-triggering, premature cycling and late cycling	20minutes