Condition category
Respiratory
Date applied
01/02/2020
Date assigned
10/02/2020
Last edited
10/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://www.srrsh.com/html/main/gb2312/

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

Publication citations

Additional files

Editorial Notes

10/02/2020: Trial’s existence confirmed by Ethics committee of Sir Run Run Shaw Hospital of Zhejiang University.