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

NCT05401253 | Completed

• 1 other identifier: YXLL-KY-2022(014)
• Study Type: observational
• Target: 245
• Locations: 1 country
• Sites: 1

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

Keywords

Postoperative pulmonary complications; Lung resection surgery; Physical activity; General anesthesia

Outcome Measures

Primary Outcomes (1)

• Incidence of pulmonary complications

  1. Respiratory Infection 2. Respiratory Failure 3. Pleural Effusion 4. Atelectasis 5. Pneumothorax 6. Bronchospasm 7. Aspiration pneumonitis

  Within five days after surgery

Secondary Outcomes (7)

• The arterial levels of inflammatory markers

  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).

• The number of postoperative pulmonary complications

  Within five days after the surgery

• Extubation time

  The time from the end of surgery to the removal of the endotracheal intubation.

• Postoperative length of stay

  During the study procedure

• Incidence of postoperative adverse events

  Within five days after operation

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patients older than 18 years and younger than 80 years;
• Patients scheduled to accept elective thoracic surgery under general anesthesia;
• Patients of American Society of Anesthesiologists (ASA) Ⅱ～Ⅲ level grade;
• Patients signed the informed consent form for the clinical study.

You may not qualify if:

• Patients with moderate or severe chronic obstructive pulmonary disease (GOLD Grade III or IV level grade)；
• Patients with severe or uncontrolled bronchial asthma；
• Patients with severe neuromuscular disease or thoracic malformation；
• Patients with severe heart disease (New York Heart Association Class III or IV level grade or acute coronary syndrome or persistent ventricular arrhythmia)；
• Patients with cognitive dysfunction；
• Patients who have participated in other clinical trials within the previous 30 days；
• Patients with coagulation dysfunction；
• Patients who received radiotherapy or chemotherapy within 2 months before surgery.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

China, Shandong Qianfoshan Hospital

Jinan, Shandong, 250014, China

Location

Related Publications (1)

• 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.

  PMID: 38749692 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Arterial blood samples from patients

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Changping Gu, doctor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: June 2, 2022
• Study Start: May 1, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)