Temperature Management on Postoperative Delirium

NCT06406257 | Not Yet Recruiting

• 1 other identifier: 2024-keyan-045
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Emergence Delirium

Keywords

Postoperative Delirium; Body Temperature; Hyperthermia; Hypothermia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of intraoperative hypothermia

  During operation

• Pleiotropic cytokine in the patient's serum

  Serum interleukin-6 (IL-6) levels before surgery and at 1, 2, and 3 days after surgery.

Study Arms (2)

Group C

NO INTERVENTION

Patients in Group C will be covered with a bedsheet intraoperatively without active warming methods employed.

Group W

EXPERIMENTAL

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

Interventions

3M™ Bair Hugger™ Warming Unit DEVICE

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.

Group W

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wang Hongjian: lead
• The Second Hospital of Anhui Medical University: collaborator

MeSH Terms

Conditions

Emergence Delirium; Hyperthermia; Hypothermia

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Body Temperature Changes; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Xianwen Hu, PhD

  The Second Hospital of Anhui Medical University

  STUDY CHAIR

Central Study Contacts

Hongjian Wang, MD

CONTACT

+86 15806019263; wanghj_a@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending doctor

Model Details: Enrolled participants were randomly assigned to a control group (Group C) or a body temperature protection group (Group W) in a 1:1 ratio.

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 9, 2024
• Study Start: May 20, 2024
• Primary Completion: February 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share