Identify and understand patient-ventilator asynchrony in patients with mechanical ventilation using electrical impedance tomography
| ISRCTN | ISRCTN91644265 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91644265 |
| Secondary identifying numbers | 20210728-34 |
- Submission date
- 09/08/2021
- Registration date
- 25/08/2021
- Last edited
- 31/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
The concept of safe mechanical ventilation continues to develop, especially for special diseases, such as acute respiratory distress syndrome (ARDS) and chronic obstructive pulmonary disease (COPD), ventilation strategy based on respiratory mechanics and lung-protective ventilation, in order to provide life support for critically ill patients and minimize iatrogenic injury. When the patient and ventilator do not match in the respiratory transmission process, patient ventilation asynchrony (PVA) will occur between the patient and ventilator. The high incidence of asynchrony is associated with prolonged hospitalization and death. Electrical impedance tomography (EIT) can evaluate the regional distribution of lung during ventilation, with time and space information, so as to provide the basis for lung protection and diaphragm protection ventilation.
Who can participate?
ICU patients over 18 years old who requiring invasive mechanical ventilation
What does the study involve?
This study is an observational study, which only collects the patients’ clinical data (basic data, ventilator waveform, esophageal internal pressure, and gas distribution in the lung), and alveolar lavage fluid (this biological sample is the sample to be collected in the process of routine clinical diagnosis and treatment, which is not a special requirement of this study), does not interfere with the clinical diagnosis and treatment process.
What are the possible benefits and risks of participating?
None
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?
July 2021 to March 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Miss Jie Ding, 2233702918@qq.com
Contact information
Public
Sir Run Run Shaw Hospital Affiliated to Medical College of Zhejiang University
3 QingChun East Road
Jianggan District
HangZhou
310016
China
| Phone | +86 18268113280 |
|---|---|
| 2233702918@qq.com |
Study information
| Study design | Single-centre observational cross-sectional cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Identification and mechanism of patient-ventilator asynchrony (PVA) in patients with mechanical ventilation by electrical impedance tomography (EIT) |
| Study objectives | The purpose of this study is to explore the identification of man-machine asynchrony and its mechanical mechanism in patients with mechanical ventilation by EIT, as well as the impact of different subtypes on the prognosis of patients, so as to provide basis for lung protection and diaphragm protection ventilation. |
| Ethics approval(s) | Approved 28/07/2021, Ethics committee of Shaw Hospital Affiliated to Zhejiang University (3 qingchun east road, jianggan district, hangzhou; +86 (0)571-86960497; yyc261@foxmail.com), ref: 310016 |
| Health condition(s) or problem(s) studied | Patients requiring invasive mechanical ventilation |
| Intervention | After the eligible patients are enrolled, we will use the respcare information system continuously and automatically collect the ventilator waveform and record the respiratory mechanical parameters. We will also use the gastric tube to monitor esophageal pressure and observe the gas distribution in the lung by chest wall electrical impedance imaging every day, the identify invalid trigger (IEE), double trigger (DT) and reverse trigger (RT) in PVA through the machine . All the above will help us identify and analyse the mechanical mechanism of PVA in patients with mechanical ventilation. 1. Collection of basic data: disease diagnosis, severity score (SAPS II, sofa), presence or absence of sepsis, chest imaging, laboratory examination (ABG, cx3, CX4, CBC), treatment and outcome. Use standardized data collection tables. Identification results and clinical interpretation. 2. The Respcare information system continuously and automatically collects the ventilator waveform and records the respiratory mechanical parameters: Pvent, PMUs, paw, ers, RRs, PES, PL, Pplat, flow and volume. 3. Through gastric tube (including esophageal pressure monitoring): place the gastric tube with esophageal pressure measurement function, calibrate and measure the esophageal internal pressure (4 times a day, 1 hour each time, 10 hours in total). 4. The gas distribution in the lung was observed by chest wall electrical impedance imaging (4 times a day, 1 hour each time, a total of 10 hours): by comparing the impedance change with the reference state, the improved Newton Raphson algorithm was used to reconstruct the tidal volume distribution image. The regional and overall velocity variation process is recorded with a velocity resolution of 20Hz.The overall impedance time curve is the sum of all pixel impedance changes. 5. Identify invalid trigger (IEE), double trigger (DT) and reverse trigger (RT) in PVA through machine learning. 6. 5ml of partial alveolar lavage fluid was reserved and sent for cell analysis. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Current primary outcome measures as of 31/08/2021: 1. Esophageal internal pressure (4 times a day, 1 hour each time) measured using the ventilator 2. To assess the accuracy of EIT in identifying PVA, the gas distribution in the lung was observed by chest wall electrical impedance imaging (4 times a day, 1 hour each time). By comparing the impedance change with the reference state, the improved Newton Raphson algorithm was used to reconstruct the tidal volume distribution image. 3. Incidence and type of PVA were recorded throughout the duration of mechanical ventilation _____ Previous primary outcome measures: 1. Esophageal internal pressure (4 times a day, 1 hour each time) measured using the ventilator 2. The gas distribution in the lung was observed by chest wall electrical impedance imaging (4 times a day, 1 hour each time): by comparing the impedance change with the reference state, the improved Newton Raphson algorithm was used to reconstruct the tidal volume distribution image. 3. Incidence and type of PVA were recorded throughout the duration of mechanical ventilation |
| Secondary outcome measures | Current primary outcome measures as of 31/08/2021: 1. As continuous assessment of respiratory physiological aspects and mechanics of different subtypes, the Respcare information system continuously and automatically collects the ventilator waveform and records the respiratory mechanical parameters throughout the duration of mechanical ventilation: PES, Pplat, flow and volume 2. Length of stay and mortality were recorded at the end of mechanical ventilation _____ Previous secondary outcome measures: 1. The Respcare information system continuously and automatically collects the ventilator waveform and records the respiratory mechanical parameters throughout the duration of mechanical ventilation: PES, Pplat, flow and volume. 2. Length of stay and mortality were recorded at the end of mechanical ventilation |
| Overall study start date | 20/07/2021 |
| Completion date | 20/03/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 35 |
| Key inclusion criteria | 1. Patients admitted to ICU from August 2021 to December 2022 2. Age ≥18 years old 3. Patients with mechanical ventilation 4. Voluntarily participate and sign the informed consent form (in case of incapacity, its legal representative must sign the informed consent on behalf of it) |
| Key exclusion criteria | 1. Signed the doctor's order against resuscitation (DNR) 2. Patients transferred from other intensive care units 3. No effective mechanical ventilation waveform 4. Unable to conduct EIT assessment |
| Date of first enrolment | 01/08/2021 |
| Date of final enrolment | 30/12/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Jianggan District
Hangzhou
310016
China
Sponsor information
Hospital/treatment centre
Affiliated to medical College of Zhejiang University
3 QingChun East Road
Jianggan District
Hangzhou
310016
China
| Phone | +86 (0)571-86960497 |
|---|---|
| yyc261@foxmail.com | |
| Website | http://www.srrsh.com/html/main/gb2312/ |
"ROR" |
https://ror.org/00ka6rp58 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request (ding_yuejia@zju.edu.cn) |
Editorial Notes
31/08/2021: The following changes have been made:
1. The primary outcome measures have been changed.
2. The secondary outcome measures have been changed.
11/08/2021: Trial's existence confirmed by Ethics committee of Shaw Hospital Affiliated to Zhejiang University.
