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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

3992 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-29

Study Completion Date

2032-06-30

Brief Summary

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Intraoperative hypothermia is common in patients having major surgery and the compliance with intraoperative temperature monitoring and management remains poor. Studies suggest that intraoperative hypothermia is an important risk factor of postoperative delirium, which is associated with worse early and long-term outcomes. Furthermore, perioperative hypothermia increases stress responses and provokes immune suppression, which might promote cancer recurrence and metastasis. In a recent trial, targeted temperature management reduced intraoperative hypothermia and emergence delirium. There was also a trend of reduced postoperative delirium, although not statistically significant. This trial is designed to test the hypothesis that intraoperative targeted temperature management may reduce postoperative delirium and improves progression-free survival in older patients recovering from major cancer surgery.

Detailed Description

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Perioperative hypothermia results from anesthetic-impaired thermoregulatory responses combined with cool operating rooms and exposed body cavities. Core temperatures \<35.5°C increases perioperative blood loss, delays post anesthetic recovery, and increases surgical wound infections.

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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Cancer Surgery Hypothermia Delirium Long-term Survivors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

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.

Group Type PLACEBO_COMPARATOR

Routine thermal management

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Target temperature management

Intervention Type OTHER

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.

Intervention Type OTHER

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℃.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age ≥65 years.
2. Planned potentially curative initial cancer surgery with an expected duration of 2 hours or longer under general anesthesia.

Exclusion Criteria

1. Preoperative fever (tympanic temperature ≥38℃).
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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role collaborator

Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong-Xin Wang

Professor and Chairman, Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status NOT_YET_RECRUITING

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status RECRUITING

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status NOT_YET_RECRUITING

Maanshan People's Hospital

Ma’anshan, Anhui, China

Site Status NOT_YET_RECRUITING

Dongzhimen Hospital Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Guang'anmen Hospital China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Aerospace Medical Center

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

Beijing Chuanyangliu Hospital

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

Beijing Coal Group General Hospital

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

Beijing Electric Power Hospital

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

The First Hospital of Tsinghua University

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)

Shijiazhuang, Hebei, China

Site Status NOT_YET_RECRUITING

First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status RECRUITING

The First Affiliated Hospital Of Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Site Status NOT_YET_RECRUITING

Jingzhou Central Hospital

Jingzhou, Hubei, China

Site Status NOT_YET_RECRUITING

Jiangyin People's Hospital

Jiangyin, Jiangsu, China

Site Status RECRUITING

The First Affiliated Hospital of Kangda College of Nanjing Medical University ( Lianyungang First People's Hospital)

Lianyungang, Jiangsu, China

Site Status NOT_YET_RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status NOT_YET_RECRUITING

The People's Hospital of Wuxi

Wuxi, Jiangsu, China

Site Status NOT_YET_RECRUITING

Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China

Site Status RECRUITING

The First Affiliated Hospital Of Shandong First Medical University

Jinan, Shandong, China

Site Status NOT_YET_RECRUITING

The People's Hospital of Liaocheng

Liaocheng, Shandong, China

Site Status RECRUITING

Chengdu Seventh People's Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Chengdu Medical College

Chengdu, Sichuan, China

Site Status RECRUITING

The Second People's Hospital of Yibin (affiliated with West China Hospital of Sichuan University)

Chengdu, Sichuan, China

Site Status NOT_YET_RECRUITING

Deyang People's Hospital

Deyang, Sichuan, China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Dong-Xin Wang, MD, PhD

Role: CONTACT

8610 83572784

Xin-quan Liang, MD

Role: CONTACT

+8615210846532

Facility Contacts

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Ming-sheng Bao

Role: primary

+86 15339668345

Ye Zhang, MD

Role: primary

Xuesheng Liu

Role: primary

+86 18655193385

Jun Jing

Role: primary

86 13965378174

Guo-kai Liu

Role: primary

8610-80816655

Xin-Quan Liang, MD

Role: primary

+86 15210846532

Xi-chen Dong

Role: primary

+86 13810248772

Xiu-mei Gao

Role: primary

+86 13810208575

Li-jian Pei

Role: primary

8610-65296114

Zhanmin Yang

Role: primary

86 18610197799

Yanwei Yang

Role: primary

86 18612596817

Yonggang Li

Role: primary

86 13241867130

Wenyong Han

Role: primary

86 13671003131

Duomao Lin

Role: primary

86 13811495413

Su Min

Role: primary

+86 13508302749

Tao Luo

Role: primary

+86 13510820779

Chao Li

Role: primary

Kun Wang, MD

Role: primary

Jian-jun Yang

Role: primary

+86 13357739238

Jia-qiang Yang

Role: primary

+86 13937121360

Kun Zhang

Role: primary

86 18107168484

Jian-qing Chen

Role: primary

+86 18921233188

Yong Wu

Role: primary

86 18961325621

Cun-ming Liu

Role: primary

+86 13951890866

Jiang Zhu

Role: primary

86 13962153438

Xin Zhang

Role: primary

+86 13818832760

Zhi-Hong Lu, MD

Role: primary

+86 13891975018

Jian-bo Wu

Role: primary

+86 13805319310

Chong-wang Zhang

Role: primary

+86 13346256809

Hui Zhong

Role: primary

+86 18280318565

Qian Lei

Role: primary

+86 17744339891

Ping-liang Yang

Role: primary

+86 18140064602

Jinghua Ren, M.D.

Role: primary

8613568084991

Xianjie Zhang, M.D.

Role: primary

86 13981088319

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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