The effect of mistimed mechanical breathing assistance on patient outcomes
| ISRCTN | ISRCTN17848241 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17848241 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 20190916-16 |
| Sponsor | Sir Run Run Shaw Hospital, school of medicine, Zhejiang university |
| Funder | Sir Run Run Shaw Hospital, school of medicine, Zhejiang university |
- 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
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
Scientific
3 QingChun East Road
Jianggan district
HangZhou
310016
China
| Phone | +86 13588706787 |
|---|---|
| gehq@zju.edu.cn |
Scientific
3 QingChun East Road
Jianggan district
HangZhou
310016
China
| Phone | +86 18268113280 |
|---|---|
| 2233702918@qq.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Cross-sectional cohort study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| 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 |
| Study acronym | PVA |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
The incidence of PVA during the mechanical ventilation time |
| Key secondary outcome measure(s) |
Analysis of the related factors of PVA incidence: |
| Completion date | 15/11/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Key inclusion criteria | 1. Age above 18 years 2. Admitted to the intensive care unit and on invasive mechanical ventilation |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 15/11/2019 |
| Date of final enrolment | 15/11/2020 |
Locations
Countries of recruitment
- China
Study participating centre
Jianggan district
HangZhou
310000
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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
