NCT07251439

Brief 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. 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started Jan 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress23%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

September 26, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 26, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

November 26, 2025

Status Verified

June 1, 2025

Enrollment Period

2 years

First QC Date

September 26, 2025

Last Update Submit

November 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    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.

    From date of the operation until the date of complete remission, assessed up to 30 days

  • Length of stay

    From date of admission to hospital until the date of discharge, assessed up to 30 days

  • ICU admission rate

    From date of the operation until the date of discharge, assessed up to 30 days

  • 30-day readmission rate

    From date of discharge until the date of readmission, assessed up to 30 days

Interventions

A wireless body temperature transducer is located under the auxiliary. The body temperature is continuously monitored perioperatively.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled to accept video-assisted thoracoscopic surgery.

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung NeoplasmsDiseaseAgnosiaPostoperative Complications

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Chief of the department of Anesthesiology

Study Record Dates

First Submitted

September 26, 2025

First Posted

November 26, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

November 26, 2025

Record last verified: 2025-06