Postoperative Pulmonary ComplicationsNCT05401253
The Association of Different Levels of Physical Activity on Postoperative Pulmonary Complications in Patients Undergoing Thoracoscopic Lung Resection Surgery
An observational study of Postoperative Pulmonary Complications, run by Qianfoshan Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pulmonary Complications
- How many people
- 245 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18~80 years undergoing elective thoracoscopic lung resection surgery under general anesthesia
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pulmonary complications
- Respiratory Infection
- Respiratory Failure
- Pleural Effusion
- Atelectasis
- Pneumothorax
- Bronchospasm
- Aspiration pneumonitis
Measured: Within five days after surgery
Secondary outcomes (7)
The arterial levels of inflammatory markers
interleukin-6(IL-6), interleukin-8(IL-8), tumor necrosis factor-α(TNF-α)
Measured: 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
Measured: Within five days after the surgery
Extubation time
Measured: The time from the end of surgery to the removal of the endotracheal intubation.
Postoperative length of stay
Measured: During the study procedure
Incidence of postoperative adverse events
- arrhythmia
- acute cardiovascular disease (myocardial infarction, heart failure)
- acute cerebrovascular disease (cerebral infarction, cerebral hemorrhage, TIA)
- acute postoperative psychiatric disorder (delirium,somnolence,coma)
- shock
Measured: Within five days after operation
Unplanned admission to the ICU
Measured: Within five days after operation
Mortality 1 month after surgery
Measured: Within 1 month of the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 May 2022
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pulmonary ComplicationsStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Changping Gu, Qianfoshan Hospital
- Investigators
- Changping Gu, doctor, Principal investigator, Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401253
- Sponsor's protocol ID
- YXLL-KY-2022(014)
- Status last verified
- Mar 2024
- First submitted
- 25 Apr 2022
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38749692
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05401253
- Acronym / sponsor ID
- YXLL-KY-2022(014)
- Conditions
- Postoperative Pulmonary Complications
- Keywords
- Postoperative pulmonary complications, Lung resection surgery, Physical activity, General anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18~80 years undergoing elective thoracoscopic lung resection surgery under general anesthesia
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
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).
The number of postoperative pulmonary complications
Time frame: Within five days after the surgery
Extubation time
Time frame: The time from the end of surgery to the removal of the endotracheal intubation.
Postoperative length of stay
Time frame: During the study procedure
Incidence of postoperative adverse events
Time frame: Within five days after operation
Unplanned admission to the ICU
Time frame: Within five days after operation
Mortality 1 month after surgery
Time frame: Within 1 month of the end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Derived from this study: PubMed 38749692Qiu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Changping Gu, doctor principal investigator
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pulmonary Complications, run by Qianfoshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pulmonary complications (time frame: Within five days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05401253, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.