The effect of mistimed mechanical breathing assistance on patient outcomes

ISRCTN ISRCTN17848241
DOI https://doi.org/10.1186/ISRCTN17848241
Secondary identifying numbers 20190916-16
Submission date
06/11/2019
Registration date
12/11/2019
Last edited
05/11/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Huiqing Ge
Scientific

3 QingChun East Road
Jianggan district
HangZhou
310016
China

Phone +86 13588706787
Email gehq@zju.edu.cn
Miss Jie Ding
Scientific

3 QingChun East Road
Jianggan district
HangZhou
310016
China

Phone +86 18268113280
Email 2233702918@qq.com

Study information

Study designCross-sectional cohort study
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleThe 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
Study acronymPVA
Study objectivesMismatch 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(s)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
Health condition(s) or problem(s) studiedPatients with invasive mechanical ventilation
InterventionFrom 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 typeOther
Primary outcome measureThe incidence of PVA during the mechanical ventilation time
Secondary outcome measuresAnalysis 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 study start date02/09/2019
Completion date15/11/2020

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsat least 300
Key inclusion criteria1. Age above 18 years
2. Admitted to the intensive care unit and on invasive mechanical ventilation
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment15/11/2019
Date of final enrolment15/11/2020

Locations

Countries of recruitment

  • China

Study 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

Sir Run Run Shaw Hospital, school of medicine, Zhejiang university
Hospital/treatment centre

3 QingChun East Road
Jianggan district
HangZhou
310016
China

Phone +86 571 86006811
Email 594961420@qq.com
ROR logo "ROR" https://ror.org/00ka6rp58

Funders

Funder type

University/education

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

No information available

Results and Publications

Intention to publish date15/11/2021
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe current data sharing plans for this study are unknown and will be available at a later date

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2020 05/11/2020 Yes No

Editorial Notes

05/11/2020: Publication reference added.
11/11/2019: Trial’s existence confirmed by Ethics committee of Sir Run Run Shaw Hospital of Zhejiang University