NCT02881385

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.Some ventilators have auto cycle function Based on curves of pressure on respiratory patterns,it will make the transforming more synchrony with humans.Our prospective observational study will prove the superiority of the auto cycle function.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

11 months

First QC Date

July 30, 2016

Last Update Submit

September 10, 2016

Conditions

Keywords

SynchronyPressure Support Ventilation

Outcome Measures

Primary Outcomes (1)

  • patient-ventilator synchrony using PSV mode between different ventilator for 180mins

    180mins after the patients involved

Secondary Outcomes (4)

  • Patient Respiratory Patterns during Pressure Support Ventilation for 180mins

    180mins

  • Patient gas exchange during Pressure Support Ventilation for 180mins

    180mins

  • Effects on Respiratory Patterns in different Expiratory triggering sensitivity for 180mins

    180mins

  • work of triggering and respiratory in different Expiratory triggering sensitivity for 180mins

    180mins

Study Arms (7)

E5 Esense 10%

PSV mode using E5 ventilator with Esense 10%

E5 Esense 30%

PSV mode using E5 ventilator with Esense 30%

E5 Esense 50%

PSV mode using E5 ventilator with Esense 50%

Servo-I Esense 10%

PSV mode using Servo-I ventilator with Esense 10%

Servo-I Esense 30%

PSV mode using Servo-I ventilator with Esense 30%

Servo-I Esense 50%

PSV mode using Servo-I ventilator with Esense 50%

E5 Esense autocycle

PSV mode using E5 ventilator with Esense Auto cycle

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

mechanical ventilation adult people using PSV mode in ICU

You may qualify if:

  • ARDS,COPD and Postoperative patient

You may not qualify if:

  • variety of reasons can not be placed next to the bed by the nasal EAdi catheter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Distress SyndromePulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physician

Study Record Dates

First Submitted

July 30, 2016

First Posted

August 29, 2016

Study Start

September 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

September 13, 2016

Record last verified: 2016-09