The effect of airway pressure release ventilation on respiration and circulation in post-operative heart surgery patients
| ISRCTN | ISRCTN92666776 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92666776 |
| Secondary identifying numbers | 20181225-6 |
- Submission date
- 01/02/2020
- Registration date
- 10/02/2020
- Last edited
- 28/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Postoperative lung (pulmonary) complications and heart (cardiovascular) complications are major causes of morbidity, mortality and resource utilization in cardiac surgery patients. Patients undergoing cardiopulmonary bypass (CPB) frequently experience hypoxemia and pulmonary complications after surgery and may develop acute respiratory distress syndrome. In addition, improper postoperative ventilator settings are associated with an increased risk for lung infection, a longer duration of intubation and a longer hospital stay.
Airway pressure release ventilation (APRV) is a lung protective strategy that has been proposed to treat refractory hypoxemic respiratory failure while preventing ventilator-induced lung injury . However, APRV introduces a higher mean airway pressure (Pmean) compared to conventional ventilation mode, which may increase intrathoracic pressure, and subsequently right atrial pressure. Hence, APRV might lead to a decrease in systemic venous return compared to conventional mechanical ventilation. A randomized controlled trial was designed to compare APRV with conventional PCV.
Who can participate?
Patients aged over 18 years who receive cardiothoracic surgery and need invasive mechanical ventilation after admission to the ICU.
What does the study involve?
Patients are randomly divided into routine ventilation group (PCV group) and APRV group and treated accordingly.
What are the possible benefits and risks of participating?
The use of APRV mode during postoperative respiratory support may promote pulmonary retention after general anesthesia, reduce postoperative complications, and shorten mechanical ventilation and ICU stay.And during the study, we continued to monitor the patient's ventilation indicators and vital signs. The electrical impedance imaging test used in the study was non-invasive in vitro, requiring only chest straps placed before and after the roll, without frequent movement. Therefore, this study is relatively safe.
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?
December 2018 to December 2021
Who is funding the study?
Sir Run Run Shaw Hospital Affiliated to Medical College of Zhejiang University (China)
Who is the main contact?
Mrs Jie Ding
2233702918@qq.com
Contact information
Scientific
3 Qingchun East Road
Jianggan District
Hangzhou
310016
China
| Phone | +86 18268113280 |
|---|---|
| 2233702918@qq.com |
Study information
| Study design | Interventional 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 below to request a patient information sheet |
| Scientific title | The effect of airway pressure release ventilation (APRV) on the incidence of postoperative pulmonary complications in patients with cardiothoracic surgery |
| Study objectives | The use of APRV mode in post-operative cardiac surgery patients can promote pulmonary retention after general anesthesia, reduce postoperative complications and shorten mechanical ventilation and ICU stay. |
| Ethics approval(s) | Approved 25/12/2018, Ethics committee of Sir Run Run Shaw Hospital of Zhejiang University (3 Qingchun East Road, Jianggan District, Hangzhou, 310016, China; +86 571 8600681; 594961420@qq.com), ref: 20181225-6 |
| Health condition(s) or problem(s) studied | Postoperative pulmonary complications and cardiovascular complications |
| Intervention | Patients who receive cardiothoracic surgery and need invasive mechanical ventilation after admission to the ICU are randomly divided into routine ventilation group (PCV group) and APRV group. The random scheme is generated by referring to the random comparison table without any restriction, intervention or adjustment in advance or in the process of implementation. All patients are supported by Evita4 ventilator, and the initial parameters of a ventilator in the PCV group are set as follows: respiratory frequency 12 times/min, tidal volume 6-8ml/ ideal kg body weight, inhalation oxygen concentration and positive end-expiratory pressure (PEEP) are set according to the needs of patients. The initial respiratory rate, tidal volume, and inhaled oxygen concentration of the APRV group are set the same as that of the conventional ventilator group, with the low pressure set to 0, and the low pressure time (Tlow) is set at the time required to reduce the flow rate at pressure release to 50%-75% of the peak flow rate. The distribution of functional residual gas and tidal gas is measured by EIT equipment at the time of enrollment, 30min and 1h after enrollment. Vital signs and respiratory physiological indicators are also recorded as well as the incidence of ventilator-associated pneumonia, atelectasis, mechanical ventilation duration, length of ICU stay, and final prognosis. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Evita4 ventilator |
| Primary outcome measure | Electrical impedance imaging (EIT) was used to determine the difference in pulmonary gas distribution in patients undergoing cardiothoracic surgery before and after admission to the ICU after APRV |
| Secondary outcome measures | From patient records: 1. Incidence of ventilator-associated pneumonia 2. Incidence of atelectasis 3. Duration of mechanical ventilation 4. Length of ICU stay 5. Final outcome (death/survival) |
| Overall study start date | 25/12/2018 |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | PCV group: 30 and APRV group:30 |
| Key inclusion criteria | 1. Age above 18 2.Received cardiothoracic surgery and needed invasive mechanical ventilation after admission to the ICU |
| Key exclusion criteria | 1. Chronic obstructive pulmonary disease 2. Asthma 3. Mechanical ventilation pre-operation 4. Mechanical device to maintain hemodynamics |
| Date of first enrolment | 26/12/2018 |
| Date of final enrolment | 26/12/2021 |
Locations
Countries of recruitment
- China
Study participating centre
Jianggan District
Hangzhou
310016
China
Sponsor information
Hospital/treatment centre
3 Qingchun East Road
Jianggan District
Hangzhou
310016
China
| Phone | +86 (0)571 86006664 |
|---|---|
| wangjing0919@srrsh.com | |
| Website | http://www.srrsh.com/html/main/gb2312/ |
"ROR" |
https://ror.org/00ka6rp58 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/05/2022 |
|---|---|
| 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 beginning 9 months and ending 36 months following article publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 03/06/2021 | 28/03/2023 | Yes | No |
Editorial Notes
28/03/2023: Publication reference added.
11/06/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 26/05/2020 to 26/12/2021.
2. The overall trial end date was changed from 20/06/2020 to 31/12/2021.
3. The intention to publish date was changed from 20/05/2021 to 31/05/2022.
10/02/2020: Trial’s existence confirmed by Ethics committee of Sir Run Run Shaw Hospital of Zhejiang University.
