Postoperative ComplicationsNCT05582291
Effect of Daytime Variation on PPCs in Lung Resection Surgery.
An observational study of Postoperative Complications, run by Qianfoshan Hospital at 1 site in China.
Trial summary
The aim of this retrospective study was to evaluate the association between daytime variation in surgery start time and the occurrence of postoperative pulmonary complications (PPCs) and postoperative adverse events (AEs) in patients who underwent lung resection under general anaesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- How many people
- 1,138 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2022to 20 Sep 2022
- 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 years and older
- All sexes
- Adult, Older adult
Study population: This study enrolled adult patients who required lung resection under general anaesthesia in the Department of Thoracic Surgery of the First Affiliated Hospital of Shandong First Medical University from 2017 to 2022.
Who may be able to join
- Required lung resection under general anaesthesia in the Department of Thoracic Surgery of the First Affiliated Hospital of Shandong First Medical University from 2017 to 2022
- Surgery starts between 7 AM and 11 AM or between 12 PM and 17 PM
- Age ≥ 18 years old
Who cannot join
- Lost to follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Daytime Variation in Lung Resection Surgery on Postoperative Pulmonary Complications: a Single-centre Retrospective Study.
The aim of this retrospective study was to evaluate the association between daytime variation in surgery start time and the occurrence of postoperative pulmonary complications (PPCs) and postoperative adverse events (AEs) in patients who underwent lung resection under general anaesthesia.
Read the detailed description
The study included a total of 1138 patients who underwent lung resection in investigators's hospital from 2017 to 2022. Patients who underwent surgery between 7 and 11 ante meridiem (AM) versus between 12 and 5 post meridiem (PM) were compared regarding the incidence of PPCs and postoperative AEs. The patients' data were obtained from the electronic surgical case system and intraoperative anaesthesia records by professionals in the Big Data Center of the First Affiliated Hospital of Shandong First Medical University. Using medical record numbers and dates of surgery, investigators collected the following information: sex, age, height, weight, American Society of Anesthesiologists classification, complications, anesthesia and surgery duration, postoperative analgesia, type of operation, selective surgery, intraoperative blood transfusion, progress notes, postoperative imaging (e.g., chest X-ray, computed tomography) and related laboratory test results. Patients were stratified by morning or afternoon surgery. All data analyses were performed using open source statistical computing software (R, version 4.1.2; www.r-project.org). Categorical variables were expressed as frequencies and percentages, and comparisons between groups were performed using either the X² or Fisher's exact tests. Continuous variables were expressed as mean±standard deviation or median [interquartile range] according to whether the data conformed to a normal distribution. The independent samples t-test was used for comparisons between groups for normally distributed data, and the Mann--Whitney U test was used for non-normally distributed data. By convention, two-sided statistical significance was assumed, with P<0.05. For variables with a missing data rate of < 25% , investigators used multiple imputations by chained equations to meet the statistical requirements.
To check the consistency of the findings, co-variate balancing propensity score matching was performed. In the propensity score matching, investigators used nearest neighbour matching with a specified caliper distance (0.25) to minimise the potential impact of differences in the baseline variables on the endpoints. In accordance with the Assess Respiratory Risk in Surgical Patients in Catalonia system, patients in the morning surgery group were matched 1:1 with patients in the afternoon surgery group regarding age, weight, American Society of Anesthesiologists classification, smoking, chronic obstructive pulmonary disease, hypertension, coronary heart disease, preoperative anaemia, diabetes, type of surgery, duration of surgery, selective surgery, and intraoperative blood transfusion. Investigators also performed a sensitivity analysis according to the department of presentation (Thoracic Surgery I and Thoracic Surgery II) and type of surgery to verify the robustness of the statistical analysis results.
- Conditions
- Postoperative Complications
- Keywords
- diurnal variation, general anaesthesia, lung function, lung resection, postoperative complications
- Medical subject headings
- Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of postoperative pulmonary complications and postoperative adverse events
By reviewing the patient's postoperative imaging (e.g., chest X-ray, computed tomography), related laboratory test results and surgical case records.
Measured: up to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start12 Jan 2022
- Primary completion21 Aug 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 1,138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gu, Principal investigator, China, Shandong Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582291
- Sponsor's protocol ID
- XMSBLL2022(126)
- Status last verified
- Oct 2022
- First submitted
- 12 Oct 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Daytime Variation in Lung Resection Surgery on Postoperative Pulmonary Complications: a Single-centre Retrospective Study.
- ClinicalTrials.gov ID
- NCT05582291
- Acronym / sponsor ID
- XMSBLL2022(126)
- Conditions
- Postoperative Complications
- Keywords
- diurnal variation, general anaesthesia, lung function, lung resection, postoperative complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,138 participants (actual)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 21 Aug 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 17 Oct 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.
The aim of this retrospective study was to evaluate the association between daytime variation in surgery start time and the occurrence of postoperative pulmonary complications (PPCs) and postoperative adverse events (AEs) in patients who underwent lung resection under general anaesthesia.
Detailed description
The study included a total of 1138 patients who underwent lung resection in investigators's hospital from 2017 to 2022. Patients who underwent surgery between 7 and 11 ante meridiem (AM) versus between 12 and 5 post meridiem (PM) were compared regarding the incidence of PPCs and postoperative AEs. The patients' data were obtained from the electronic surgical case system and intraoperative anaesthesia records by professionals in the Big Data Center of the First Affiliated Hospital of Shandong First Medical University. Using medical record numbers and dates of surgery, investigators collected the following information: sex, age, height, weight, American Society of Anesthesiologists classification, complications, anesthesia and surgery duration, postoperative analgesia, type of operation, selective surgery, intraoperative blood transfusion, progress notes, postoperative imaging (e.g., chest X-ray, computed tomography) and related laboratory test results. Patients were stratified by morning or afternoon surgery. All data analyses were performed using open source statistical computing software (R, version 4.1.2; www.r-project.org). Categorical variables were expressed as frequencies and percentages, and comparisons between groups were performed using either the X² or Fisher's exact tests. Continuous variables were expressed as mean±standard deviation or median [interquartile range] according to whether the data conformed to a normal distribution. The independent samples t-test was used for comparisons between groups for normally distributed data, and the Mann--Whitney U test was used for non-normally distributed data. By convention, two-sided statistical significance was assumed, with P<0.05. For variables with a missing data rate of < 25% , investigators used multiple imputations by chained equations to meet the statistical requirements.
To check the consistency of the findings, co-variate balancing propensity score matching was performed. In the propensity score matching, investigators used nearest neighbour matching with a specified caliper distance (0.25) to minimise the potential impact of differences in the baseline variables on the endpoints. In accordance with the Assess Respiratory Risk in Surgical Patients in Catalonia system, patients in the morning surgery group were matched 1:1 with patients in the afternoon surgery group regarding age, weight, American Society of Anesthesiologists classification, smoking, chronic obstructive pulmonary disease, hypertension, coronary heart disease, preoperative anaemia, diabetes, type of surgery, duration of surgery, selective surgery, and intraoperative blood transfusion. Investigators also performed a sensitivity analysis according to the department of presentation (Thoracic Surgery I and Thoracic Surgery II) and type of surgery to verify the robustness of the statistical analysis results.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study enrolled adult patients who required lung resection under general anaesthesia in the Department of Thoracic Surgery of the First Affiliated Hospital of Shandong First Medical University from 2017 to 2022.
Key inclusion criteria (3 listed)
- Required lung resection under general anaesthesia in the Department of Thoracic Surgery of the First Affiliated Hospital of Shandong First Medical University from 2017 to 2022
- Surgery starts between 7 AM and 11 AM or between 12 PM and 17 PM
- Age ≥ 18 years old
Key exclusion criteria (1 listed)
- Lost to follow-up
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
The occurrence of postoperative pulmonary complications and postoperative adverse events
Time frame: up to two weeks
By reviewing the patient's postoperative imaging (e.g., chest X-ray, computed tomography), related laboratory test results and surgical case records.
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 31 Oct 2022.
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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.
Gu principal investigator
China, Shandong Qianfoshan Hospital
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 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 3 inclusion and 1 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 31 Oct 2022. 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?
The occurrence of postoperative pulmonary complications and postoperative adverse events (time frame: up to two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2022.