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Completed

NCT Number: NCT05401253

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

China, Shandong Qianfoshan Hospital

Jinan, Shandong, 250014, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence of pulmonary complications

    Time frame: Within five days after surgery

    • Respiratory Infection
    • Respiratory Failure
    • Pleural Effusion
    • Atelectasis
    • Pneumothorax
    • Bronchospasm
    • Aspiration pneumonitis

Secondary outcomes

  1. The arterial levels of inflammatory markers

    Time frame: 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).

    interleukin-6(IL-6), interleukin-8(IL-8), tumor necrosis factor-α(TNF-α)

  2. The number of postoperative pulmonary complications

    Time frame: Within five days after the surgery

  3. Extubation time

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

  4. Postoperative length of stay

    Time frame: During the study procedure

  5. Incidence of postoperative adverse events

    Time frame: Within five days after operation

    • arrhythmia
    • acute cardiovascular disease (myocardial infarction, heart failure)
    • acute cerebrovascular disease (cerebral infarction, cerebral hemorrhage, TIA)
    • acute postoperative psychiatric disorder (delirium,somnolence,coma)
    • shock
  6. Unplanned admission to the ICU

    Time frame: Within five days after operation

  7. Mortality 1 month after surgery

    Time frame: Within 1 month of the end of surgery

Sponsors and collaborators

Lead sponsor

Qianfoshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 2, 2022
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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