Brief Summary

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.

Trial Health

On Track

Trial Health Score

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

Enrollment

3,992

participants targeted

Target at P75+ for not_applicable

Timeline

72mo left

Started May 2024

Longer than P75 for not_applicable

Geographic Reach

1 country

36 active sites

Status

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

8 years study duration

Study Progress27%

May 2024Jun 2032

First Submitted

Initial submission to the registry

February 5, 2024

Completed

8 days until next milestone

First Posted

Study publicly available on registry

February 13, 2024

Completed

4 months until next milestone

Study Start

First participant enrolled

May 29, 2024

Completed

5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Expected

3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2032

Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

5 years

First QC Date

February 5, 2024

Last Update Submit

June 18, 2026

Conditions

Long-term Survivors Cancer Surgery Intraoperative Hypothermia Targeted Temperature Management Postoperative Delirium

Keywords

Cancer surgeryIntraoperative hypothermiaTargeted temperature managementPostoperative deliriumLong-term survival

Outcome Measures

Primary Outcomes (1)

Incidence of delirium within 4 days after surgery
Occurrence of delirium during the first four postoperative days is assessed with the 3D-Confusion Assessment Method (3D-CAM) or Confusion Assessment Method for the Intensive Care Unit (CAM-ICU; for intubated patients) twice daily (8-10 am and 6-8 pm). Any positive CAM evaluation will be considered evidence of delirium. Immediately before assessing delirium, sedation or agitation is assessed with the Richmond Agitation-Sedation Scale (RASS; scores range from -5 \[unarousable\] to +4 \[combative\] and 0 indicates alert and calm). Deeply sedated or unarousable patients (RASS -4 or -5) is recorded as comatose and not assessed for delirium.
During the first four days after surgery.

Secondary Outcomes (4)

Postoperative thermal comfort
Up to 30 minutes after arriving PACU/ICU or after extubation.
Postoperative shivering intensity
Up to 30 minutes after arriving PACU/ICU or after extubation.
Incidence of emergence delirium
Up to 30 minutes after arriving PACU/ICU or after extubation.
Units of blood transfused during and within 4 days of surgery
Up to 4 days after surgery.

Other Outcomes (14)

Length of stay in post-anesthesia care unit (PACU)
Up to 24 hours after surgery.
Quality of Recovery-15 score on the first day after surgery
Up to 24 hours after surgery.
Change in hemoglobin from baseline (last preoperative concentration) to the lowest concentration on the first day after surgery
Up to 24 hours after surgery.
+11 more other outcomes

Study Arms (2)

Routine thermal management

PLACEBO COMPARATOR

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.

Other: Routine thermal management

Target temperature management

EXPERIMENTAL

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.

Other: Target temperature management

Interventions

Target temperature managementOTHER

Target temperature management

Routine thermal managementOTHER

Routine thermal management

Eligibility Criteria

Age65 Years+

Sexall

Healthy VolunteersNo

Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

Preoperative fever (tympanic temperature ≥38℃).
Known or suspected preoperative infection.
Previous history of schizophrenia, epilepsy, Parkinson disease, myasthenia gravis, or delirium.
Unable to communicate due to severe dementia, language barrier, or coma.
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).
Scheduled surgery for breast cancer, intracranial tumors, or rare cancers.
Planned to undergo therapeutic hypothermia.
Body mass index \>30 kg/m2 (to facilitate thermal management).
Have participated in this study previously.
Any other conditions that are considered unsuitable for study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Peking Universitycollaborator
Peking University First Hospitallead

Study Sites (36)

The People's Hospital of Chizhou

Chizhou, Anhui, 247099, China

NOT YET RECRUITING

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

RECRUITING

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 610042, China

RECRUITING

Maanshan People's Hospital

Ma’anshan, Anhui, China

RECRUITING

Dongzhimen Hospital Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100007, China

NOT YET RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Guang'anmen Hospital China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100055, China

RECRUITING

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100091, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Aerospace Medical Center