Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05582291 |
| Other study ID # |
XMSBLL2022(126) |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 12, 2022 |
| Est. completion date |
September 20, 2022 |
Study information
| Verified date |
October 2022 |
| Source |
Qianfoshan Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
