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Effect of Six Character Formula on Postoperative Pulmonary Complications after Cardiac Surgery: a randomized controlled trial

Registration number：

ITMCTR2200006051

Date of Last Refreshed on：

2022-06-02

Date of Registration：

2022-06-02

Registration Status：

Prospective registration

Public title：

Effect of Six Character Formula on Postoperative Pulmonary Complications after Cardiac Surgery: a randomized controlled trial

English Acronym：

Scientific title：

Effect of Six Character Formula on Postoperative Pulmonary Complications after Cardiac Surgery

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2200060482 ; ChiMCTR2200006051

Applicant：

Qing Yin

Study leader：

Qing Yin

Applicant telephone：

15622310156

Study leader's telephone：

15622310156

Applicant Fax：

Study leader's fax：

Applicant E-mail：

yinqing255@163.com

Study leader's E-mail：

yinqing255@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Department of Anesthesiology, Guangdong Hospital of traditional Chinese Medicine, 111 Dade Road, Yuexiu District, Guangzhou

Study leader's address：

Department of Anesthesiology, Guangdong Hospital of traditional Chinese Medicine, 111 Dade Road, Yuexiu District, Guangzhou

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Guangdong Hospital of traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

ZF2022-102-01

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine

Date of approved by ethic committee：

1990/1/1 0:00:00

Contact Name of the ethic committee：

Contact Address of the ethic committee：

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

Guangdong Hospital of traditional Chinese Medicine

Primary sponsor's address：

Guangdong Provincial Hospital of Chinese Medicine,111 Dade Road, Yuexiu District, Guangzhou

Secondary sponsor：

Country：

China

Province：

Guangdong Provincia

City：

Institution
hospital：

Guangdong Hospital of traditional Chinese Medicine

Address：

Guangdong Provincial Hospital of Chinese Medicine,111 Dade Road, Yuexiu District, Guangzhou

Source(s) of funding：

Self-financing

Target disease：

Postoperative Pulmonary Complications

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

To determine the efficacy and safety of perioperative six character formula training on postoperative pulmonary complications after cardiac surgery.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

（1）Patients aged ≥18 years； （2）Patients undergoing elective cardiac surgery (coronary artery bypass graft surgery, valve surgery）with general anesthesia; （3）ASA II～IV； （4）Patients voluntarily participated and signed informed consent form; （5）Patients cooperate with that training and obtain complete result information.

Exclusion criteria：

(1)Preoperative history of acute lung injury or acute respiratory distress syndrome in last 3 months; (2)History of intubation or mechanical ventilation within 60 days prior to surgery; (3)Chronic obstructive pulmonary disease (COPD),obstructive sleep apnea ,asthma, restrictive lung disease, preoperative major chest infection, e.g. pulmonary tuberculosis, chest deformities such as pectus carinatum, pectus excavatum, thoracolumbar scoliosis, diaphragmatic hernias diagnosed on history; (4)Patients who have long-term use of hormone therapy before surgery (≥3 months); (5)Patients who may have reoperation within 7 days after surgery; (6)Critical illness, including severe hepatic dys function (eg, hepatic failure), chronic renal failure (glomerular filtration rate <30 mL/min); (7)BMI＞30kg/m2 (8) Patients with cognitive or neurological defcits; (9)Patients having pregnant; (10)Emergency operation; (11)Patients undergoing any other surgery together with coronary artery bypass graft surgery or valve surgery; (12)Robotic surgery or minimally invasive surgery; (13)Ventricular assist devices are needed during or after operation.

Study execute time：

From 2022-02-01

To      2024-06-30

Recruiting time：

From 2022-06-15

To      2023-11-30

Interventions：

58

Group：

Control group

Sample size：

Intervention：

Routine pulmonary protective measures

Intervention code：

58

Group：

test group

Sample size：

Intervention：

perioperative six character formula training and routine pulmonary protective measures

Intervention code：

Total sample size ： 116

Countries of recruitment
and research settings：

Country：

China

Province：

Guangdong

City：

Institution/hospital：

Guangdong Hospital of traditional Chinese Medicine

Level of the institution：

Provincial

Outcomes：

Outcome：

Hospitalization fee

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

postoperative hospitalization

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Incidence of pulmonary infection within 7 days postoperation

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Incidence of pulmonary complications (PPCs) in the 30 days postoperative

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Postoperative pulmonary function

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Postoperative 30-day mortality

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Incidence of pulmonary complications (PPCs) in the 7 days postoperative

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Incidence of atelectasis within 7 days postoperative

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

the PPCs severity score within 7 days after surgery

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

length of ICU stay postoperative

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Adverse event rates

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Incidence of hydrothorax within 7 days postoperative

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Postoperative arterial oxygen saturation

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Mechanical ventilation duration

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Not yet recruiting

Min age years
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

According to the randomization list generated by investigator from Microsoft Excel, all patients will be allocated in a 1:1 treatment ratio to test group or control group.

Blinding：

IPD sharing：

Yes

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

The paper will be written and published within 6 months after the research completed.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Case Record Form, CRF

Data Managemen Committee：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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