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

NCT ID: NCT05401253

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 245 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-11-30

Brief 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.

Conditions

Postoperative Pulmonary Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adequate physical activity group

At least 600 met-minutes /week for five or more days of walking, moderate and strenuous physical activity per week.

No interventions assigned to this group

Insufficient physical activity group

Less than 600 met-minutes /week for five or more days of walking, moderate and strenuous physical activity per week.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qianfoshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Changping Gu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Changping Gu, doctor

Role: PRINCIPAL_INVESTIGATOR

Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University

Locations

China, Shandong Qianfoshan Hospital

Jinan, Shandong, China

Countries

China

References

Qiu L, Zhao L, Wang B, Yang L, Cao C, Lv M, Xu M, Hou M, Wang X, Wang Y, Gu CP. Predicting the association of different levels of physical activity on postoperative pulmonary complications using the international physical activity questionnaire in patients undergoing thoracoscopic lung surgery under general anaesthesia: protocol for a prospective cohort study. BMJ Open. 2024 May 15;14(5):e077183. doi: 10.1136/bmjopen-2023-077183.

Reference Type: DERIVED

PMID: 38749692 (View on PubMed)

Other Identifiers

YXLL-KY-2022(014)

Identifier Type: -

Identifier Source: org_study_id