The Association of Different Levels of Physical Activity on Postoperative Pulmonary Complications in Patients Undergoing Thoracoscopic Lung Resection Surgery

Postoperative Pulmonary Complications Clinical Trial

Official title:

The Association of Different Levels of Physical Activity on Postoperative Pulmonary Complications in Patients Undergoing Thoracoscopic Lung Resection Surgery: A Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05401253
• Other study ID #: YXLL-KY-2022(014)
• Status: Completed
• Start date: May 1, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: March 2024
• Source: Qianfoshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aimed to predict different physical activity (PA) levels in patients undergoing thoracoscopic lung resection surgery (LRS) using the International Physical Activity Questionnaire (IPAQ) and investigate the association between the PA levels and the incidence of postoperative pulmonary complications (PPCs). The patients were classified into the high-level and low-level PA groups based on the IPAQ scores. The incidence of PPCs within postoperative 5 days, number of PPCs, the incidence of postoperative adverse events (PAEs) within postoperative 5 days, extubation time, length of hospital stay (LOS), unplanned admission to the intensive care unit (ICU), and the mortality 1-month postoperatively were recorded. Arterial blood samples were collected before induction of anesthesia and 1 hour postoperatively, and the supernatants were centrifuged for cytokine analysis. Binomial logistic analysis was performed to determine the relationship between predefined variables and PPCs. Receiver operating characteristic (ROC) curve analysis was performed to identify independent risk factors, and the area under the curve (AUC) was calculated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients older than 18 years and younger than 80 years;

2. Patients scheduled to accept elective thoracic surgery under general anesthesia;

3. Patients of American Society of Anesthesiologists (ASA) ?~? level grade;

4. Patients signed the informed consent form for the clinical study.

Exclusion Criteria:

1. Patients with moderate or severe chronic obstructive pulmonary disease (GOLD Grade III or IV level grade);

2. Patients with severe or uncontrolled bronchial asthma;

3. Patients with severe neuromuscular disease or thoracic malformation;

4. Patients with severe heart disease (New York Heart Association Class III or IV level grade or acute coronary syndrome or persistent ventricular arrhythmia);

5. Patients with cognitive dysfunction;

6. Patients who have participated in other clinical trials within the previous 30 days;

7. Patients with coagulation dysfunction;

8. Patients who received radiotherapy or chemotherapy within 2 months before surgery.

Related Conditions & MeSH terms

• Postoperative Pulmonary Complications

Locations

Country	Name	City	State
China	China, Shandong Qianfoshan Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of pulmonary complications	Respiratory Infection; Respiratory Failure; Pleural Effusion; Atelectasis; Pneumothorax; Bronchospasm; Aspiration pneumonitis	Within five days after surgery
Secondary	The arterial levels of inflammatory markers	interleukin-6(IL-6), interleukin-8(IL-8), tumor necrosis factor-a(TNF-a)	before induction of anesthesia(T0),1.5 hours after the beginning of surgery(T2),3 hours after the beginning of surgery(T3)and 1 hour after the end of surgery(T4).
Secondary	The number of postoperative pulmonary complications		Within five days after the surgery
Secondary	Extubation time		The time from the end of surgery to the removal of the endotracheal intubation.
Secondary	Postoperative length of stay		During the study procedure
Secondary	Incidence of postoperative adverse events	arrhythmia; acute cardiovascular disease (myocardial infarction, heart failure); acute cerebrovascular disease (cerebral infarction, cerebral hemorrhage, TIA); acute postoperative psychiatric disorder (delirium,somnolence,coma); shock	Within five days after operation
Secondary	Unplanned admission to the ICU		Within five days after operation
Secondary	Mortality 1 month after surgery		Within 1 month of the end of surgery