Plain English Summary
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 June 2020
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
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Jie Ding
ORCID ID
Contact details
3 Qingchun East Road
Jianggan District
Hangzhou
310016
China
+86 18268113280
2233702918@qq.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
20181225-6
Study information
Scientific title
The effect of airway pressure release ventilation (APRV) on the incidence of postoperative pulmonary complications in patients with cardiothoracic surgery
Acronym
Study hypothesis
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
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
Study design
Interventional randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
25/12/2018
Overall trial end date
20/06/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age above 18
2.Received cardiothoracic surgery and needed invasive mechanical ventilation after admission to the ICU
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
PCV group: 30 and APRV group:30
Participant exclusion criteria
1. Chronic obstructive pulmonary disease
2. Asthma
3. Mechanical ventilation pre-operation
4. Mechanical device to maintain hemodynamics
Recruitment start date
26/12/2018
Recruitment end date
26/05/2020
Locations
Countries of recruitment
China
Trial participating centre
Sir Run Run Shaw Hospital Affiliated to Medical College of Zhejiang University
3 Qingchun East Road
Jianggan District
Hangzhou
310016
China
Sponsor information
Organisation
Sir Run Run Shaw Hospital
Sponsor details
3 Qingchun East Road
Jianggan District
Hangzhou
310016
China
+86 (0)571 86006664
wangjing0919@srrsh.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Sir Run Run Shaw Hospital Affiliated to Medical College of Zhejiang University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
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.
Intention to publish date
20/05/2021
Participant level data
Available on request
Basic results (scientific)
Publication list