Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04931589 |
Other study ID # |
2020-004 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 1, 2020 |
Est. completion date |
June 11, 2021 |
Study information
Verified date |
January 2021 |
Source |
Second Affiliated Hospital, School of Medicine, Zhejiang University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
In this study, the "Curve of Intraoperative Body Temperature Change in Patients with VATS
Surgery" was taken as the main research content to retrospectively analyze the intraoperative
body temperature and its change rules of patients who met the research conditions, and draw a
trend curve, namely, the curve of body temperature change.Taking "time" as the independent
variable and "body temperature" as the dependent variable, the correlation between the two
was statistically analyzed.Through the development of the body temperature change curve, we
can further understand the phenomenon that the body temperature of patients undergoing VATS
surgery changes with the progress of surgery, and longitudinal understand the change trend
and the general rule of the body temperature change.The results can provide a basis for
clinical development of scientific preoperative evaluation plan, hypothermia prevention
strategy and intraoperative intervention plan.
Description:
Lung cancer is a common malignant tumor. With the increasingly serious air pollution and the
arrival of the aging society, the prevalence of lung cancer is increasing year by
year.According to the Globocan 2018 Cancer Report, published 2018 by the International Agency
for Research on Cancer (IARC) of the World Health Organization,Lung cancer accounted for
11.6% of new cases and 18.4% of deaths from malignancies globally in 2018, ranking first
among malignancies.As the mainstream surgical treatment of lung cancer, video-assisted
thoracic surgery (VATS) has many advantages such as less trauma and rapid recovery of
patients, and has become one of the preferred methods for the treatment of lung cancer,
especially early lung cancer.It has been widely used at home and abroad.However, with the
more and more extensive development of VATS surgery, the phenomenon of intraoperative
hypothermia in patients is relatively common clinically.The study results of Cywinski et al.
showed that the rate of hypothermia after thoracoscopic surgery could reach
50%.Intraoperative hypothermia can lead to adverse effects such as increased cardiovascular
events, coagulation dysfunction, prolonged wound recovery time, increased risk of wound
infection, immune system suppression, and slow drug metabolism [7].
Perioperative hypothermia means that the body's core body temperature is less than 36℃ due to
various reasons during the perioperative period, also known as perioperative unexpected
hypothermia or unplanned perioperative hypothermia.Perioperative hypothermia can be caused by
any factor that may affect thermoregulation.Risk factors affecting thermoregulation mainly
include patient anesthesia factors, self factors, surgical factors, environmental factors,
etc. [13].Operation when the room temperature is too low, inadequate coverage and other
factors leading to excessive heat loss surgery (room temperature as a given intravenous
fluids and rinses, evaporation of the skin disinfectant, etc.), lead to the low temperature
of unplanned, patients not only affect the function of blood coagulation, lead to increased
perioperative blood loss, also can increase the risk of cardiovascular events, and can
suppress the immune function,It can lead to postoperative infection and even more serious
adverse outcomes.Intraoperative hypothermia involved in this study includes perioperative
hypothermia, which is an important clinical manifestation of perioperative hypothermia.It is
found in clinical practice that the proportion of intraoperative hypothermia in patients
undergoing VATS surgery is high, which is closely related to the specific surgical position
and surgical site.
Current studies on intraoperative hypothermia in patients undergoing VATS surgery [15-16]
mainly focus on the comparison of intervention methods, including the selection of
intervention methods, the effect comparison of heating equipment, or the effect comparison of
heating sites.However, there has been no in-depth study on the specific changes of body
temperature and the trend of body temperature changes during VATS surgery.At the same time,
the intervention time point for intraoperative hypothermia is mainly judged by clinical
experience, and there is a lack of support from objective data studies.Clinical observation
shows that the changes of body temperature in patients undergoing VATS surgery are not a
straight line, nor a simple arc, but a curve that changes continuously with the operation
time.
In this study, the "Curve of Intraoperative Body Temperature Change in Patients with VATS
Surgery" was taken as the main research content to retrospectively analyze the intraoperative
body temperature and its change rules of patients who met the research conditions, and draw a
trend curve, namely, the curve of body temperature change.Taking "time" as the independent
variable and "body temperature" as the dependent variable, the correlation between the two
was statistically analyzed.Through the development of the body temperature change curve, we
can further understand the phenomenon that the body temperature of patients undergoing VATS
surgery changes with the progress of surgery, and longitudinal understand the change trend
and the general rule of the body temperature change.The results can provide a basis for
clinical development of scientific preoperative evaluation plan, hypothermia prevention
strategy and intraoperative intervention plan.Moreover, it can further study the influence of
various factors, such as surgical factors, anesthesia factors and patients' own factors, on
the temperature change curve, so as to provide a basis for clinical intervention.