Lung Cancer (Diagnosis)NCT07251439
Impact of Perioperative Body Temperature on Postoperative Complications and Pain in Video-assisted Thoracoscopic Surgery Patients Utilizing Continuous Temperature Monitoring
An observational study of Lung Cancer (Diagnosis) and Pain Management, run by Peking University People's Hospital.
Trial summary
A report from the National Cancer Center (published in JNCC) shows that lung cancer has the highest rates of both new cases and deaths in China. Surgery using a tiny camera (thoracoscopic surgery) is a main treatment for early-stage lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (Diagnosis), Pain Management, Postoperative Complications
- What is being tested?
- Continuous body temperature monitoring
- Type of treatment
- Medical device
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled to accept video-assisted thoracoscopic surgery.
Who may be able to join
- American Society of Anesthesiologist (ASA) I - III
- BMI 18.5 - 30 kg/m²
- Scheduled for Video-assisted thoracoscopic surgery (VATS) lung/mediastinal tumor resection (duration ≥1 hour)
- General anesthesia with regional block (thoracic paravertebral block and serratus anterior plane block)
- Written informed consent.
Who cannot join
- ASA ≥ IV
- Preoperative fever (>37.5°C) or hypothermia (<36.0°C)
- Chronic pain or opioid use ≥ 3 months
- Immunosuppression
- Thyroid dysfunction
- Neurological dysfunction affecting pain assessment
Show all 9Show fewer
- Emergency surgery or conversion to thoracotomy
- Planned surgery <1 hour or requiring cardiopulmonary bypass
- Failed regional block (sensory block not covering T2-T8 at 4h postoperation)
About this study
Official title: Impact of Perioperative Body Temperature on Postoperative Complications and Pain in Video-assisted Thoracoscopic Surgery Patients Utilizing Continuous Temperature Monitoring: A Prospective Cohort Study
A report from the National Cancer Center (published in JNCC) shows that lung cancer has the highest rates of both new cases and deaths in China. Surgery using a tiny camera (thoracoscopic surgery) is a main treatment for early-stage lung cancer. However, this type of chest surgery carries a much higher risk of patients developing low body temperature during the operation compared to other surgeries. This is because: (1) The surgery is complex and takes longer； (2) The chest cavity is open and exposed to the cool operating room air; (3)General anesthesia affects the brain's ability to regulate temperature and widens blood vessels, causing faster heat loss.Studies show that low body temperature happens in about 65-73% of these chest surgeries, while the average for surgeries longer than 2 hours nationwide is only about 40%.
Low body temperature during surgery isn't just a problem at the time. It also increases the risk of negative outcomes after surgery. As known, it worsens post-surgery pain and increases risks of complications, such as infections, heart problems and bleeding issues.
Read more
A common pain control technique for chest surgery is injecting local anesthesia medicine near the spine (Thoracic Paravertebral Block or TPVB). This technique is very effective at reducing pain after surgery, both short-term and long-term. However, new research suggests this nerve block might cause blood vessels to widen, potentially making patients lose body heat faster during surgery. Because TPVB is used so often, it's hard to tell if low body temperature during surgery directly causes worse pain afterwards, or if the nerve block itself influences both temperature and pain. The potential connection between low temperature caused by TPVB and later pain is not yet clear.
The objective of this study is to investigate how low body temperature during and around the time of surgery affects complications after surgery (such as infections, heart and lung problems, longer hospital stays, etc.) in patients undergoing thoracic surgery. The investigators also aim to find the relationship between low body temperature during surgery and the occurrence of pain after surgery.
- Conditions
- Lung Cancer (Diagnosis), Pain Management, Postoperative Complications, Body Temperature Measurement
- Being tested
- Continuous body temperature monitoring
- Medical subject headings
- Lung Neoplasms, Disease, Agnosia, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous body temperature monitoringDevice
A wireless body temperature transducer is located under the auxiliary. The body temperature is continuously monitored perioperatively.
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Measured: From date of the operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 days
Secondary outcomes (4)
Pain intensity measured by Numeric Rating Scale on a scale from 0 to 10, where 0 indicates no pain and 10 signifies the worst possible pain. Scores between 1 and 3 typically represent mild pain, 4 to 6 moderate pain, and 7 to 10 severe pain.
Measured: From date of the operation until the date of complete remission, assessed up to 30 days
Length of stay
Measured: From date of admission to hospital until the date of discharge, assessed up to 30 days
ICU admission rate
Measured: From date of the operation until the date of discharge, assessed up to 30 days
30-day readmission rate
Measured: From date of discharge until the date of readmission, assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Feng, MD, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251439
- Sponsor's protocol ID
- 2025-h067
- Status last verified
- Jun 2025
- First submitted
- 26 Sep 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Perioperative Body Temperature on Postoperative Complications and Pain in Video-assisted Thoracoscopic Surgery Patients Utilizing Continuous Temperature Monitoring: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07251439
- Acronym / sponsor ID
- 2025-h067
- Conditions
- Lung Cancer (Diagnosis), Pain Management, Postoperative Complications, Body Temperature Measurement
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Nov 2025 (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.
A report from the National Cancer Center (published in JNCC) shows that lung cancer has the highest rates of both new cases and deaths in China. Surgery using a tiny camera (thoracoscopic surgery) is a main treatment for early-stage lung cancer. However, this type of chest surgery carries a much higher risk of patients developing low body temperature during the operation compared to other surgeries. This is because: (1) The surgery is complex and takes longer； (2) The chest cavity is open and exposed to the cool operating room air; (3)General anesthesia affects the brain's ability to regulate temperature and widens blood vessels, causing faster heat loss.Studies show that low body temperature happens in about 65-73% of these chest surgeries, while the average for surgeries longer than 2 hours nationwide is only about 40%.
Low body temperature during surgery isn't just a problem at the time. It also increases the risk of negative outcomes after surgery. As known, it worsens post-surgery pain and increases risks of complications, such as infections, heart problems and bleeding issues.
A common pain control technique for chest surgery is injecting local anesthesia medicine near the spine (Thoracic Paravertebral Block or TPVB). This technique is very effective at reducing pain after surgery, both short-term and long-term. However, new research suggests this nerve block might cause blood vessels to widen, potentially making patients lose body heat faster during surgery. Because TPVB is used so often, it's hard to tell if low body temperature during surgery directly causes worse pain afterwards, or if the nerve block itself influences both temperature and pain. The potential connection between low temperature caused by TPVB and later pain is not yet clear.
The objective of this study is to investigate how low body temperature during and around the time of surgery affects complications after surgery (such as infections, heart and lung problems, longer hospital stays, etc.) in patients undergoing thoracic surgery. The investigators also aim to find the relationship between low body temperature during surgery and the occurrence of pain after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to accept video-assisted thoracoscopic surgery.
Key inclusion criteria (5 listed)
- American Society of Anesthesiologist (ASA) I - III
- BMI 18.5 - 30 kg/m²
- Scheduled for Video-assisted thoracoscopic surgery (VATS) lung/mediastinal tumor resection (duration ≥1 hour)
- General anesthesia with regional block (thoracic paravertebral block and serratus anterior plane block)
- Written informed consent.
Key exclusion criteria (9 listed)
- ASA ≥ IV
- Preoperative fever (>37.5°C) or hypothermia (<36.0°C)
- Chronic pain or opioid use ≥ 3 months
- Immunosuppression
- Thyroid dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous body temperature monitoringA wireless body temperature transducer is located under the auxiliary. The body temperature is continuously monitored perioperatively. | Device | – |
Primary outcome
Postoperative complications
Time frame: From date of the operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 days
4 secondary outcomes
Pain intensity measured by Numeric Rating Scale on a scale from 0 to 10, where 0 indicates no pain and 10 signifies the worst possible pain. Scores between 1 and 3 typically represent mild pain, 4 to 6 moderate pain, and 7 to 10 severe pain.
Time frame: From date of the operation until the date of complete remission, assessed up to 30 days
Length of stay
Time frame: From date of admission to hospital until the date of discharge, assessed up to 30 days
ICU admission rate
Time frame: From date of the operation until the date of discharge, assessed up to 30 days
30-day readmission rate
Time frame: From date of discharge until the date of readmission, assessed up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer (Diagnosis) and Pain Management, run by Peking University People's Hospital.
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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Postoperative complications (time frame: From date of the operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 days). 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 26 Nov 2025.