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Clinical Trials/NCT05401253
NCT05401253
Completed
Not Applicable

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

Qianfoshan Hospital1 site in 1 country245 target enrollmentMay 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pulmonary Complications
Sponsor
Qianfoshan Hospital
Enrollment
245
Locations
1
Primary Endpoint
Incidence of pulmonary complications
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2022
End Date
November 30, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Qianfoshan Hospital
Responsible Party
Principal Investigator
Principal Investigator

Changping Gu

Professor

Qianfoshan Hospital

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Incidence of pulmonary complications

Time Frame: Within five days after surgery

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

Secondary Outcomes

  • 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.)
  • 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).)
  • Mortality 1 month after surgery(Within 1 month of the end of surgery)
  • Postoperative length of stay(During the study procedure)
  • Incidence of postoperative adverse events(Within five days after operation)
  • Unplanned admission to the ICU(Within five days after operation)

Study Sites (1)

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