Viewing Study NCT05582291



Ignite Creation Date: 2024-05-06 @ 6:13 PM
Last Modification Date: 2024-10-26 @ 2:43 PM
Study NCT ID: NCT05582291
Status: COMPLETED
Last Update Posted: 2022-10-31
First Post: 2022-10-12

Brief Title: Effect of Daytime Variation on PPCs in Lung Resection Surgery
Sponsor: Qianfoshan Hospital
Organization: Qianfoshan Hospital

Study Overview

Official Title: Effects of Daytime Variation in Lung Resection Surgery on Postoperative Pulmonary Complications a Single-centre Retrospective Study
Status: COMPLETED
Status Verified Date: 2022-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed Description: The study included a total of 1138 patients who underwent lung resection in investigatorss 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 eg 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 412 wwwr-projectorg Categorical variables were expressed as frequencies and percentages and comparisons between groups were performed using either the X² or Fishers exact tests Continuous variables were expressed as meanstandard 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 P005 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 025 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 11 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None