Effects of Intraoperative Targeted Temperature Management on Incidence of Postoperative Delirium and Long-term Survival
NCT ID: NCT06256354
Last Updated: 2025-09-04
Study Results
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Basic Information
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RECRUITING
NA
3992 participants
INTERVENTIONAL
2024-05-29
2032-06-30
Brief Summary
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Detailed Description
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Despite guideline recommendations, compliance with intraoperative temperature monitoring and management remains poor. In a national survey published in 2017, intraoperative hypothermia (core temperature \<36.0°C) occurred in 44% of patients having elective surgery with general anesthesia. According to a survey of anesthesiologists in six Asia-Pacific countries (Singapore, Malaysia, Philippines, Thailand, India, and South Korea), only 67% of respondents measured temperature intraoperatively during general anesthesia, and only 44% report intraoperative active warming and warming was ineffective in more than half of their patients. Perioperative hypothermia thus remains common.
The 5,056-patient PROTECT trial showed that myocardial injury, surgical site infections, and blood loss were similar in patients randomized to intraoperative core temperatures of 35.5 or 37°C. However, there are other important complications that may be caused by intraoperative hypothermia including delirium, cancer recurrence, shivering, and thermal discomfort.
Perioperative neurocognitive disorders (NCDs), especially postoperative delirium and postoperative cognitive dysfunction (POCD), are significant challenges to older patients scheduled for surgery. Delirium is a syndrome of acutely occurring and fluctuating changes in attention, level of consciousness, and cognitive function. Postoperative cognitive dysfunction refers to cognitive decline (including the ability of study, memory, action, and judgement) detected from 30 days to 12 months after surgery.
In patients aged 60 years or above, the incidence of postoperative delirium is about 12-24%. The incidence of POCD is about 7-12% at 3-month follow-up and is associated with delirium, although the relationship is probably not causal. Delirium and POCD are associated with worse perioperative outcomes including prolonged hospitalization, increased complications, and high mortality, and worse long-term outcomes including shortened overall survival, as well as increased dementia and lowered life quality.
Postoperative delirium and POCD are multifactorial. Predisposing factors include advanced age, lower educational level, cognitive impairment, comorbidities (e.g., cerebrovascular disease, diabetes, and kidney disease), alcohol abuse, and malnutrition. Precipitating factors include deep anesthesia, opioid use, benzodiazepines, intraoperative blood loss/blood transfusion, and severe pain. Hypothermia may also increase the risk of delirium.
Hypothermia provokes both autonomic and behavioral protective responses. The first autonomic response is arterio-venous shunt constriction. Thermoregulatory vasoconstriction occurs many times a day in a typical hospital environment. It is highly effective, but does not usually disturb people and is generally considered to be of little consequence. Shivering is the other primary autonomic thermoregulatory defense against cold and has a triggering threshold about 1°C below the core temperature that triggers vasoconstriction. Unlike vasoconstriction, shivering is uncomfortable for patients. Furthermore, it is accompanied by a tripling of catecholamine concentrations, hypertension, and tachycardia. Behavioral thermoregulatory defenses are mediated by thermal comfort, and provoke voluntary defensive measures such as putting on a sweater, open windows, etc. Behavioral defenses include air conditioning and building shelters and are thus far stronger than autonomic responses. Thermal comfort matters to patients and is thus worth evaluating.
Despite advances in surgery and oncology, postoperative survival decreases about 10% per year, mainly due to cancer recurrence. The development of cancer recurrence mainly depends on the balance between the invasive ability of residual cancer cells and the anti-cancer immune function. Perioperative hypothermia increases stress responses and provokes immune suppression.
The investigators therefore propose to determine whether intraoperative targeted temperature management decreases the incidence of delirium, improves thermal comfort, reduces postoperative shivering, and improves long-term survival in older patients recovering from major cancer surgery. Specifically, the investigators will test the primary short-term hypothesis that perioperative normothermia (core temperature near 36.8°C) reduces delirium over the initial 4 postoperative days. Secondary short-term hypotheses are that perioperative normothermia improves thermal comfort, reduces shivering, reduces incidence of emergence delirium, and reduces blood transfusion. The primary long-term hypothesis is that perioperative normothermia improves progression-free survival.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Routine thermal management
Patients assigned to routine thermal management will not be pre-warmed and ambient intraoperative temperature will be maintained near 20°C per routine. Only transfused blood will be warmed. An upper- or lower-body forced-air cover will be positioned over an appropriate non-operative site but will not initially be activated. Should core temperature decrease to 35.5°C, the warmer will be activated as necessary to prevent core temperature from decreasing further. The target nasopharyngeal temperature is 35.5°C.
Routine thermal management
Patients assigned to routine thermal management will not be pre-warmed and ambient intraoperative temperature will be maintained near 20°C per routine. Only transfused blood will be warmed. An upper- or lower-body forced-air cover will be positioned over an appropriate non-operative site but will not initially be activated. Should core temperature decrease to 35.5°C, the warmer will be activated as necessary to prevent core temperature from decreasing further. The target nasopharyngeal temperature is 35.5°C.
Target temperature management
Pre-warming is performed with a full-body forced-air cover and electrically heated blanket for about 30 minutes before induction of anesthesia. The warmer will initially be set to "high" which corresponds to about 43°C. It will be subsequently adjusted to make patients feel warm, but not uncomfortably so. Patients will be warmed during surgery using two forced-air covers or combining forced-air covers with electric heating blanket when clinically practical. All intravenous fluids will be warmed to body temperature. There is no need to control ambient temperature since ambient temperature has little effect on core temperature in patients warmed with forced air. The target nasopharyngeal temperature is 36.8°C.
Target temperature management
Pre-warming is performed with a full-body forced-air cover and electrically heated blanket for about 30 minutes before induction of anesthesia. The warmer will initially be set to "high" which corresponds to about 43°C. It will be subsequently adjusted to make patients feel warm, but not uncomfortably so. Patients will be warmed during surgery using two forced-air covers or combining forced-air covers with electric heating blanket when clinically practical. All intravenous fluids will be warmed to body temperature. There is no need to control ambient temperature since ambient temperature has little effect on core temperature in patients warmed with forced air. The target nasopharyngeal temperature is 36.8℃.
Interventions
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Routine thermal management
Patients assigned to routine thermal management will not be pre-warmed and ambient intraoperative temperature will be maintained near 20°C per routine. Only transfused blood will be warmed. An upper- or lower-body forced-air cover will be positioned over an appropriate non-operative site but will not initially be activated. Should core temperature decrease to 35.5°C, the warmer will be activated as necessary to prevent core temperature from decreasing further. The target nasopharyngeal temperature is 35.5°C.
Target temperature management
Pre-warming is performed with a full-body forced-air cover and electrically heated blanket for about 30 minutes before induction of anesthesia. The warmer will initially be set to "high" which corresponds to about 43°C. It will be subsequently adjusted to make patients feel warm, but not uncomfortably so. Patients will be warmed during surgery using two forced-air covers or combining forced-air covers with electric heating blanket when clinically practical. All intravenous fluids will be warmed to body temperature. There is no need to control ambient temperature since ambient temperature has little effect on core temperature in patients warmed with forced air. The target nasopharyngeal temperature is 36.8℃.
Eligibility Criteria
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Inclusion Criteria
2. Planned potentially curative initial cancer surgery with an expected duration of 2 hours or longer under general anesthesia.
Exclusion Criteria
2. Known or suspected preoperative infection.
3. Previous history of schizophrenia, epilepsy, Parkinson disease, myasthenia gravis, or delirium.
4. Unable to communicate due to severe dementia, language barrier, or coma.
5. Critically ill (Left ventricular ejection fraction \<30%, Child-Pugh grades C, requirement of renal replacement therapy, American Society of Anesthesiologists physical status\>IV, or expected survival \<24 hours).
6. Scheduled surgery for breast cancer, intracranial tumors, or rare cancers.
7. Planned to undergo therapeutic hypothermia.
8. Body mass index \>30 kg/m2 (to facilitate thermal management).
9. Have participated in this study previously.
10. Any other conditions that are considered unsuitable for study participation.
65 Years
ALL
No
Sponsors
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Peking University
OTHER
Peking University First Hospital
OTHER
Responsible Party
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Dong-Xin Wang
Professor and Chairman, Department of Anesthesiology
Principal Investigators
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Dong-Xin Wang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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The People's Hospital of Chizhou
Chizhou, Anhui, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Maanshan People's Hospital
Ma’anshan, Anhui, China
Dongzhimen Hospital Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Guang'anmen Hospital China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Aerospace Medical Center
Beijing, Beijing Municipality, China
Beijing Chuanyangliu Hospital
Beijing, Beijing Municipality, China
Beijing Coal Group General Hospital
Beijing, Beijing Municipality, China
Beijing Electric Power Hospital
Beijing, Beijing Municipality, China
The First Hospital of Tsinghua University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)
Shijiazhuang, Hebei, China
First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital Of Zhengzhou University
Zhengzhou, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Jingzhou Central Hospital
Jingzhou, Hubei, China
Jiangyin People's Hospital
Jiangyin, Jiangsu, China
The First Affiliated Hospital of Kangda College of Nanjing Medical University ( Lianyungang First People's Hospital)
Lianyungang, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The People's Hospital of Wuxi
Wuxi, Jiangsu, China
Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China
The First Affiliated Hospital Of Shandong First Medical University
Jinan, Shandong, China
The People's Hospital of Liaocheng
Liaocheng, Shandong, China
Chengdu Seventh People's Hospital
Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
The First Affiliated Hospital of Chengdu Medical College
Chengdu, Sichuan, China
The Second People's Hospital of Yibin (affiliated with West China Hospital of Sichuan University)
Chengdu, Sichuan, China
Deyang People's Hospital
Deyang, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Ming-sheng Bao
Role: primary
Xuesheng Liu
Role: primary
Jun Jing
Role: primary
Xi-chen Dong
Role: primary
Zhanmin Yang
Role: primary
Yanwei Yang
Role: primary
Yonggang Li
Role: primary
Wenyong Han
Role: primary
Duomao Lin
Role: primary
Jia-qiang Yang
Role: primary
Kun Zhang
Role: primary
Jian-qing Chen
Role: primary
Yong Wu
Role: primary
Jiang Zhu
Role: primary
Jinghua Ren, M.D.
Role: primary
Xianjie Zhang, M.D.
Role: primary
References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-185
Identifier Type: -
Identifier Source: org_study_id
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