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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pulmonary Complications

• Study Type: Observational
• Enrollment (Actual): 245

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • China, Shandong Qianfoshan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients aged 18~80 years undergoing elective thoracoscopic lung resection surgery under general anesthesia

Description

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) Ⅱ～Ⅲ 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Adequate physical activity group; At least 600 met-minutes /week for five or more days of walking, moderate and strenuous physical activity per week.
Insufficient physical activity group; Less than 600 met-minutes /week for five or more days of walking, moderate and strenuous physical activity per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of pulmonary complications	Respiratory Infection; Respiratory Failure; Pleural Effusion; Atelectasis; Pneumothorax; Bronchospasm; Aspiration pneumonitis	Within five days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extubation time		The time from the end of surgery to the removal of the endotracheal intubation.
Postoperative length of stay		During the study procedure
The number of postoperative pulmonary complications		Within five days after the surgery
Mortality 1 month after surgery		Within 1 month of the end of surgery
The arterial levels of inflammatory markers	interleukin-6(IL-6), interleukin-8(IL-8), tumor necrosis factor-α(TNF-α)	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).
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
Unplanned admission to the ICU		Within five days after operation

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital
• Investigators: Principal Investigator: Changping Gu, doctor, Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 10, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Physical activity; Postoperative pulmonary complications; General anesthesia; Lung resection surgery
• Other Study ID Numbers: YXLL-KY-2022(014)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No