Effect of two different ventilator weaning modes on patients with difficulty weaning
| ISRCTN | ISRCTN72886945 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72886945 |
| Secondary identifying numbers | 2022-541-01 |
- Submission date
- 05/08/2022
- Registration date
- 14/08/2022
- Last edited
- 11/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Mechanical ventilation (breathing support) is the most commonly used life support technology for critically ill patients. Early ventilator weaning (removal of breathing support) can reduce the risk of ventilator-associated pneumonia and upper respiratory tract injury. It is very important to determine the time of weaning and extubation. Failure to wean and extubate increases related complications and hospitalization costs, prolongs mechanical ventilation time and ICU hospitalization time, and even increases the risk of death. Even if the weaning standard is reached and the spontaneous breathing test (SBT) is successfully carried out, 10-20% of the planned extubation cases fail. Difficult and delayed weaning is one of the reasons for the extension of clinical mechanical ventilation time.
Proportional assisted ventilation (PAV+) is a relatively new ventilation mode, which aims to adapt to patients' changing ventilation needs and respiratory mechanics. Previous studies have shown that compared with the traditional mode, PAV+ is simple to operate, can also improve the sleep quality of critically ill patients and promote the withdrawal of breathing support. However, there are few studies on the physiology of weaning patients with difficult weaning using PAV+ and its impact on the prognosis of patients. The aim of this study is to analyze the effectiveness of PAV+ mode as a method of weaning on patients with difficult/delayed weaning, as well as its impact on diaphragm function.
Who can participate?
Patients aged 18 years and over with difficult weaning or delayed weaning mechanical ventilation.
What does the study involve?
Participants are randomly divided into the experimental group (PAV+ group) and the control group (pressure support ventilation [PSV] group). The participants in the experimental group (PAV+) will be ventilated in PAV+ mode and PAV+ is used for a spontaneous breathing test. The participants in the control group (PSV) will be ventilated in PSV mode and PSV mode is used for a spontaneous breathing test.
What are the possible benefits and risks of participating?
PAV+ mode may be beneficial for weaning in patients with difficult/delayed weaning, and the treatment method involved in this study is mechanical ventilation. Ventilator-related lung injury and diaphragm injury may occur during mechanical ventilation. The two treatment modes in this study are commonly used in clinic, so this study does not increase the risk. In case of any related damage during the study, the study will provide timely treatment to the participants.
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 2022 to December 2024
Who is funding the study?
Medtronic (China)
Who is the main contact?
1. Kailiang Duan
2. Wenyao Fang
Contact information
Public
Sir Run Run Shaw Hospital affiliated to Medical College of Zhejiang University
3 Qingchun East Road
Shangcheng District
Hangzhou
310016
China
| Phone | +86 (0)13958124245 |
|---|---|
| aliang-11@163.com |
Public
Sir Run Run Shaw Hospital affiliated to Medical College of Zhejiang University
3 Qingchun East Road
Shangcheng District
Hangzhou
310016
China
| Phone | +86 (0)15158040420 |
|---|---|
| 275640895@qq.com |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Effectiveness of proportional assisted ventilation mode as a method of weaning on patients with difficult weaning |
| Study hypothesis | The purpose of this study is to analyze the effect of the proportional assisted ventilation (PAV+) mode on weaning outcomes in patients with difficult/delayed weaning. The changes in respiratory mechanics in patients with weaning difficulty are compared between PAV+ and pressure support ventilation (PSV) mode. |
| Ethics approval(s) | Approved 19/07/2022, ethics committee of Shaw Hospital Affiliated to Zhejiang University (3 Qingchun East Road, Jianggan District, Hangzhou, China; +86 (0)571 86960497; yyc261@foxmail.com), ref: 310016 |
| Condition | Patients requiring invasive mechanical ventilation |
| Intervention | Participants are randomly divided using a random number table into the experimental group (PAV+ group) and the control group (PSV group). The participants in the experimental group (PAV+) will be ventilated in PAV+ mode and use PAV+ for a spontaneous breathing test. The participants in the control group (PSV) will be ventilated in PSV mode and use PSV mode for a spontaneous breathing test. The PAV+ group will be set to PAV+ mode and the support level will be adjusted to meet the patients' ventilation needs. Using PAV+ for a spontaneous breathing test, the definition of success is that the subject can tolerate 25% support. If the patient does not tolerate PAV+ mode, they are changed to pressure-controlled ventilation (PCV) assist-control (A/C) mode support. The PSV group will be set as PSV mode respiratory support, and the support level will be adjusted to meet patients' ventilation needs. PSV is used for a spontaneous breathing test (PSV 5 cmh2o+peep 5 cmh2o). If the patient does not tolerate PSV mode, they are changed to PCV-A/C mode support. When the patient reaches the weaning criteria (when the condition is stable), they start weaning for half an hour per day using one of the two weaning modes. Patients are only observed during hospitalization and no follow-up will be needed. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 1. Diaphragm activity and thickening fraction evaluated by phrenic ultrasound every morning when weaning 2. Ventilator parameters and gas exchange indicators (Peak Inspiratory Pressure [PIP], positive end-expiratory pressure [PEEP], work of breathing [WOB], FiO₂, mechanical energy [MP] , maximal inspiratory pressure [MIP], rapid shallow breathing index [RSBI], pH, PaCO₂, ETCO₂, PaO2/FiO₂, etc) directly observed on the ventilator data acquisition system every day when weaning 3. First spontaneous breathing test (SBT) time, first SBT success time and extubation success time directly recorded after grouping according to the actual situation of each patient |
| Secondary outcome measures | Obtained from the patient's medical records at discharge: 1. No ventilator-free day (VFD) within 28 days 2. Length of stay in ICU 3. ICU mortality 4. Hospitalization mortality 5. Complications after extubation 6. Success rate and time of 28-day machine removal |
| Overall study start date | 01/07/2022 |
| Overall study end date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 256 |
| Participant inclusion criteria | 1. Age ≥18 years old 2. Patients with mechanical ventilation ≥48 h 3. Patients with mechanical ventilation who meet the first SBT failure (excluding iatrogenic factors) 4. Volunteer to participate in this study and sign the informed consent form. If the subject is unable to read and sign the informed consent form due to incapacity and other reasons, or the subject is a minor, his guardian is required to represent the informed process and sign the informed consent form. If the subject is unable to read the informed consent form (e.g. illiterate subjects), the witness is required to witness the informed process and sign the informed consent form |
| Participant exclusion criteria | 1. Myasthenia gravis and other neuromuscular diseases 2. Tracheoesophageal fistula, tracheomediastinal fistula 3. Patients with high endogenous peep |
| Recruitment start date | 02/09/2022 |
| Recruitment end date | 30/11/2024 |
Locations
Countries of recruitment
- China
Study participating centre
Jianggan District
HangZhou
310016
China
Sponsor information
Industry
Hangzhou Office
Hangda Road
Xihu District
Hangzhou City
Zhejiang Province
Hangzhou
310012
China
| Phone | +86 (0)400 820 1981 |
|---|---|
| hr.shanghai@medtronic.com | |
| Website | http://www.medtronic.com/cn-zh/index.html |
"ROR" |
https://ror.org/02m7bcm44 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Medtronic Inc.
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Editorial Notes
10/08/2022: Trial's existence confirmed by the ethics committee of Shaw Hospital Affiliated to Zhejiang University.
