Temperature Management on Postoperative Delirium (POD)

Effect of Intraoperative Temperature Management on Postoperative Delirium in Elderly Patients Undergoing Hip Surgery

Presently, the effects of perioperative temperature management on postoperative delirium remain ambiguous. This study endeavors to explore the influence of intraoperative temperature variations in elderly hip fracture patients on postoperative delirium.

Study Overview

• Status: Not yet recruiting
• Conditions: Emergence Delirium
• Intervention / Treatment: Device: 3M™ Bair Hugger™ Warming Unit

Detailed Description

At present, the pathophysiological mechanisms contributing to postoperative delirium in elderly hip fracture patients remain elusive, with predominant research concentrating on neural inflammation, neurotransmitter dysregulation, and metabolic irregularities. The influence of perioperative temperature management on postoperative delirium remains uncertain and may correlate with surgical modality and intraoperative temperature modulation. Hence, this study endeavors to juxtapose intraoperative temperature variations among elderly hip fracture patients, probing their ramifications on postoperative delirium.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hongjian Wang, MD; Phone Number: +86 15806019263; Email: wanghj_a@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 65 years
• Classified as American Society of Anesthesiologists I-III
• Hip surgery patients who agreed to the study

Exclusion Criteria:

• Non-consent to participate
• Diagnosed neurological or psychiatric disorders including schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis
• Coma, dementia, or language impairment affecting communication and assessment
• History of neurosurgery
• Use of antipsychotic medication preoperatively
• Body temperature exceeding 38°C within 24 hours before surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group C; Patients in Group C will be covered with a bedsheet intraoperatively without active warming methods employed.
Experimental: Group W; Patients in Group W will have a 37°C forced-air warming blanket initiated upon entering the operating room to maintain their body temperature between 36-37 degrees Celsius.	Device: 3M™ Bair Hugger™ Warming Unit; Utilizing the 3M Temperature Management Unit to ensure intraoperative body temperature of elderly hip surgery patients remains consistent with their preoperative baseline, while patients in Group C receive no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative delirium	Confusion Assessment Method (CAM) was recorded before surgery, 10 min after admission to PACU, before exiting the post-anesthesia care unit (PACU), and 1, 2, and 3 days after surgery. POD was diagnosed if the patient had at least one episode of delirium at these time points after surgery. The CAM diagnostic algorithm is based on four cardinal features of delirium: 1) acute onset and fluctuating course, 2) inattention, 3) disorganized thinking, and 4) altered level of consciousness. A diagnosis of delirium according to the CAM requires the presence of features 1, 2, and either 3 or 4.	Within 3 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intraoperative hypothermia	Perioperative hypothermia was defined as a drop in core temperature below 36 ℃. Intraoperative tympanic membrane temperature was measured to record the incidence and duration of hypothermia.	During operation
Pleiotropic cytokine in the patient's serum	Clinical trials and meta-analyses have identified the association between POD and increased perioperative levels of Interleukin-6 (IL-6), a pleiotropic cytokine that is both necessary and sufficient for postoperative memory decline in a preclinical model of POD.	Serum interleukin-6 (IL-6) levels before surgery and at 1, 2, and 3 days after surgery.

Collaborators and Investigators

• Sponsor: Wang Hongjian
• Collaborators: The Second Hospital of Anhui Medical University
• Investigators: Study Chair: Xianwen Hu, PhD, The Second Hospital of Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): May 20, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: May 2, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 12, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Hypothermia; Body Temperature; Hyperthermia; Postoperative Delirium
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium
• Other Study ID Numbers: 2024-keyan-045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Currently, it remains unclear how IPD sharing will be conducted.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No