Body Temperature ProtectionNCT04931589
A Multicentre Study of Intraoperative Body Temperature Changes in Patients Undergoing Thoracoscopic Radical Surgery for Lung Cancer
An observational study of Body Temperature Protection and Video-assisted Thoracic Surgery, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Body Temperature Protection, Video-assisted Thoracic Surgery, Lung Cancer
- How many people
- 2,156 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 11 Jun 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All surgical patients from Vast
Who may be able to join
- ① Endoscopic radical resection of lung cancer was performed with a single or porous approach.② Continuous monitoring of nasopharyngeal temperature was recorded during the whole operation (the system automatically recorded once every 5min);③ The preoperative basal metabolism was normal, and the basal body temperature was 36.5℃<T0<37.5℃ (the preoperative average body temperature in hospital);(4) total subvenous tracheal intubation anesthesia;
Who cannot join
- Patients with the minimum intraoperative temperature monitoring data >36.0℃;Cases with warm intervention immediately after the start of surgery;Patients undergoing combined surgery for other types or organs;Intraoperative monitoring of body temperature was discontinuous or abnormal (monitoring catheter was accidentally pulled out, etc.);Intraoperative endoscopic change cases;Other cases that do not meet the requirements of the study, such as individual data anomalies or cases that are far more specific than the general cases (the cases themselves are special or caused by human recording errors).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Keywords
- Thoracoscopy, Lung cancer, Surgery, Body temperature, Nursing, multicenter
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Body temperature
Temperature per 5 minutes during the operation
Measured: Estimated time for each operation is 60-240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Jan 2020
- Primary completion30 May 2021
- Study completion11 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Temperature ProtectionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2,156 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang University, Zhejiang Cancer Hospital, First Affiliated Hospital of Wenzhou Medical University
- Responsible party
- Sponsor
- Investigators
- lina Yu, Study director, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931589
- Sponsor's protocol ID
- 2020-004
- Status last verified
- Jan 2021
- First submitted
- 14 Jun 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Study of Intraoperative Body Temperature Changes in Patients Undergoing Thoracoscopic Radical Surgery for Lung Cancer
- ClinicalTrials.gov ID
- NCT04931589
- Acronym / sponsor ID
- 2020-004
- Keywords
- Thoracoscopy, Lung cancer, Surgery, Body temperature, Nursing, multicenter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,156 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Zhejiang University, Zhejiang Cancer Hospital, First Affiliated Hospital of Wenzhou Medical University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 18 Jun 2021 (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.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All surgical patients from Vast
Key inclusion criteria (1 listed)
- ① Endoscopic radical resection of lung cancer was performed with a single or porous approach.② Continuous monitoring of nasopharyngeal temperature was recorded during the whole operation (the system automatically recorded once every 5min);③ The preoperative basal metabolism was normal, and the basal body temperature was 36.5℃<T0<37.5℃ (the preoperative average body temperature in hospital);(4) total subvenous tracheal intubation anesthesia;
Key exclusion criteria (1 listed)
- Patients with the minimum intraoperative temperature monitoring data >36.0℃;Cases with warm intervention immediately after the start of surgery;Patients undergoing combined surgery for other types or organs;Intraoperative monitoring of body temperature was discontinuous or abnormal (monitoring catheter was accidentally pulled out, etc.);Intraoperative endoscopic change cases;Other cases that do not meet the requirements of the study, such as individual data anomalies or cases that are far more specific than the general cases (the cases themselves are special or caused by human recording errors).
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
Body temperature
Time frame: Estimated time for each operation is 60-240 minutes
Temperature per 5 minutes during the operation
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 18 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Body Temperature Protection
Recruiting
Study on Optimal Temperature During Cardiopulmonary Bypass (THERMIC-4)
Ischemic Heart Disease, Valvular Heart Disease
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.
lina Yu study director
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
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 Body Temperature Protection and Video-assisted Thoracic Surgery, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 1 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 18 Jun 2021. 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?
Body temperature (time frame: Estimated time for each operation is 60-240 minutes). 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 18 Jun 2021.