Clinical trial NCT05401253: The Association of Different Levels of Physical Activity on Postoperative Pulmonary Complications in Patients Undergoing Thoracoscopic Lung Resection Surgery
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pulmonary Complications
Keywords: Postoperative pulmonary complications
Lung resection surgery
Physical activity
General anesthesia
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18\~80 years undergoing elective thoracoscopic lung resection surgery under general anesthesia

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.


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.

Primary outcomes:
measure: Incidence of pulmonary complications
timeFrame: Within five days after surgery
Secondary outcomes:
measure: The arterial levels of inflammatory markers
timeFrame: 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).
measure: The number of postoperative pulmonary complications
timeFrame: Within five days after the surgery
measure: Extubation time
timeFrame: The time from the end of surgery to the removal of the endotracheal intubation.
measure: Postoperative length of stay
timeFrame: During the study procedure
measure: Incidence of postoperative adverse events
timeFrame: Within five days after operation
measure: Unplanned admission to the ICU
timeFrame: Within five days after operation
measure: Mortality 1 month after surgery
timeFrame: Within 1 month of the end of surgery
Other outcomes:
Locations:
city: Jinan
country: China
facility: China, Shandong Qianfoshan Hospital
state: Shandong
Study officials:
affiliation: Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
name: Changping Gu, doctor
role: PRINCIPAL_INVESTIGATOR
References: