Condition category
Respiratory
Date applied
06/11/2019
Date assigned
12/11/2019
Last edited
11/11/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Invasive assisted mechanical ventilation (MV) provides primary life support to the patients without the ability to breathe in the intensive care unit (ICU). A mismatch between the MV and the breathing rate controlled by the brain of the patients results in patient-ventilator asynchrony (PVA), which will lead to a series of adverse clinical outcomes. Automatic detection of PVA is highly necessary for monitoring its occurrence in clinic.

Who can participate?
Patients aged above 18 years, admitted to intensive care unit and on invasive mechanical ventilation

What does the study involve?
From enrolment to the end of their participation, we will pay attention to the incidence of patient-ventilator asynchrony during invasive mechanical ventilation and the outcome when they leave ICU. The total duration of observation is the mechanical ventilation time in ICU and the total duration of follow-up are 28 days.

What are the possible benefits and risks of participating?
Improper mechanical respiratory assistance can lead to a series of poor clinical outcomes. Based on the ventilator waveform monitoring, patient-ventilator asynchrony can be further understood on the prognosis of patients, providing a basis for the understanding and treatment of improper mechanical respiratory assistance in clinical practice. Because this is an observational trial,we will not consider the risks during our observation.

Where is the study run from?
Sir Run Run Shaw Hospital affiliated to medical college of ZheJiang University, China

When is the study starting and how long is it expected to run for?
Nov ember 2019 to November 2020

Who is funding the study?
Sir Run Run Shaw Hospital, school of medicine, Zhejiang University, China

Who is the main contact?
Dr Huiqing Ge
gehq@zju.edu.cn
Jie Ding
2233702918@qq.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Huiqing Ge

ORCID ID

Contact details

3 QingChun East Road
Jianggan district
HangZhou
310016
China
+86 13588706787
gehq@zju.edu.cn

Type

Scientific

Additional contact

Miss Jie Ding

ORCID ID

Contact details

3 QingChun East Road
Jianggan district
HangZhou
310016
China
+86 18268113280
2233702918@qq.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

20190916-16

Study information

Scientific title

The influence of the incidence of patient-ventilator asynchrony on the prognosis of mechanical ventilated patients—analysis based on the deep learning results of ventilator waveforms

Acronym

PVA

Study hypothesis

Mismatch between the MV and the need of the patients results in patient ventilator asynchrony (PVA), which will lead to a series of adverse clinical outcomes. So our observational trial is to learn more about the effects of the incidence of patient-ventilator asynchrony on the prognosis of invasive mechanical ventilated patients

Ethics approval

Approved 16/09/2019, Ethics committee of Sir Run Run Shaw Hospital of Zhejiang University (Zhejiang 310016, China; +86 571 86006811; 594961420@qq.com), ref: 20190916-16

Study design

Cross-sectional cohort study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Patients with invasive mechanical ventilation

Intervention

From enrolment to the end of their participation, we will pay attention to the incidence of patient-ventilator asynchrony during invasive mechanical ventilation and the outcome when they leave ICU. The total duration of observation is the mechanical ventilation time in ICU and the total duration of follow-up are 28 days.

Ventilator waveforms will be collected from the adults (> 18 years old) in the ICUs. Data annotation will be performed on a manually screened dataset rather than on the whole one. A self-developed software is used for annotating the waveforms in the screened dataset. We propose a 2-layer long short-term memory (LSTM) network to detect two common types of PVA – double triggering (DT) and ineffective inspiratory effort during expiration (IEE).The labels of “DT”, “IEE”, and “Others” will be given to each breath.

Intervention type

Other

Phase

Drug names

Primary outcome measure

The incidence of PVA during the mechanical ventilation time

Secondary outcome measures

Analysis of the related factors of PVA incidence:
1. Practice models and patterns of mechanical ventilation in patients during the mechanical ventilation time
2. Mechanical ventilation time
3. Mortality at 28 days

Overall trial start date

02/09/2019

Overall trial end date

15/11/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age above 18 years
2. Admitted to the intensive care unit and on invasive mechanical ventilation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

at least 300

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

15/11/2019

Recruitment end date

15/11/2020

Locations

Countries of recruitment

China

Trial participating centre

Sir Run Run Shaw Hospital affiliated to medical college of ZheJiang University
3 QingChun East Road Jianggan district
HangZhou
310000
China

Sponsor information

Organisation

Sir Run Run Shaw Hospital, school of medicine, Zhejiang university

Sponsor details

3 QingChun East Road
Jianggan district
HangZhou
310016
China
+86 571 86006811
594961420@qq.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

Sir Run Run Shaw Hospital, school of medicine, Zhejiang university

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

15/11/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/11/2019: Trial’s existence confirmed by Ethics committee of Sir Run Run Shaw Hospital of Zhejiang University