A Study on the Correlation Between Oral Health and Delirium in Surgical Inpatients

NCT06969092 | Recruiting

• 1 other identifier: XH-25-004
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

Delirium is a clinical syndrome characterized by acute attention deficits, altered consciousness, and fluctuating cognitive dysfunction, typically triggered by multifactorial causes such as physical illness, medication use, or postoperative stress . As the most common complication in hospitalized patients, delirium is highly prevalent among elderly surgical populations, with postoperative delirium (POD) occurring in 7.5%-27.5% of cases, and rates rising to 50%-70% in intensive care unit (ICU) patients . Its onset is closely associated with poor prognoses, including long-term postoperative cognitive decline , increased mortality, prolonged hospitalization, and elevated healthcare costs (annual costs in the United States ranging from 38billionto152 billion) . Early prevention and screening of POD are therefore critical to improving patient outcomes and reducing healthcare burdens. Surgical patients' oral health issues exhibit multifactorial pathogenesis: intrinsic factors (e.g., age-related tooth loss, malnutrition-induced mucosal repair impairment, and chewing dysfunction due to reduced skeletal muscle mass) and iatrogenic factors (e.g., endotracheal intubation trauma, salivary secretion suppression from analgesics, and inadequate perioperative oral care). Poor oral health in hospitalized patients is often attributable to aging, physical dependence, cognitive decline, malnutrition, low skeletal muscle mass/strength, and comorbidities. The recently proposed concept of "Oral Frailty"-a progressive decline in oral structure and function-strongly predicts physical frailty, dysphagia, malnutrition, long-term care needs, and mortality in community-dwelling older adults The impact of oral health on cognitive function may involve three pathways : Mechanical pathway: Tooth loss disrupts masticatory motor function, reduces cerebral blood flow, and diminishes afferent stimulation from peripheral receptors (e.g., periodontal ligaments), leading to weakened neural connectivity and regional brain atrophy. Neurodegenerative pathway: Tooth loss accelerates neuronal damage via apoptosis and mitophagy, increasing amyloid-beta deposition in the brain. Inflammatory/metabolic pathway: Systemic inflammation, metabolic dysregulation, microbial-gut-brain axis interactions, and activation of microglia/astrocytes drive neuroinflammatory cascades in the central nervous system. Given these connections, oral frailty may act as an independent risk factor distinct from general frailty and a potential contributor to POD. These findings suggest that oral frailty could serve as a unique biomarker for perioperative neurocognitive disorders, mediating their pathogenesis. Systematic investigation into the spatiotemporal relationship and mechanisms linking oral health to POD in surgical patients holds significant clinical value for developing multimodal prevention strategies.

Conditions

Oral Health

Keywords

Oral Health; Oral Frailty; Surgical; Surgery; Delirium; Endotracheal Intubation; Cognitive Function

Outcome Measures

Primary Outcomes (1)

• Delirium

  First, assess the patient's consciousness using the Richmond Agitation-Sedation Scale (RASS). This scale categorizes sedation levels into 10 grades, ranging from +4 (combative) to -5 (comatose), with each score corresponding to a distinct state of consciousness. Next, perform delirium assessment using the Confusion Assessment Method for the ICU (CAM-ICU).he Chinese version of CAM-ICU evaluates delirium through four domains: * fluctuating Mental Status ②Attention Deficits * Disorganized Thinking ④Altered Consciousness Clarity A delirium diagnosis is confirmed if criteria ① and ② are met, along with either ③ and/or ④. Consciousness comprises two components: arousal level and awareness content. To assess delirium, begin by evaluating arousal level using the RASS. If the patient's RASS score is not -4 or -5 (indicating adequate arousal), proceed with delirium evaluation.

  Within One Week Postoperatively

Secondary Outcomes (3)

• dysphagia

  48 hours after removal of the endotracheal tube

• appetite

  48 hours after removal of the endotracheal tube

• Serum albumin

  Postoperative serum albumin levels are routinely assessed within the first week after surgery.

Study Arms (2)

Oral Frailty Group

Other: Oral Frailty

Non-Oral Frailty Group

Interventions

Oral Frailty OTHER

The exposure factor is the presence of oral frailty in patients before surgery, and oral frailty is evaluated using a scale.

Oral Frailty Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective cardiac surgery under general anesthesia requiring endotracheal intubation

You may qualify if:

• Patients aged ≥18 years scheduled for elective cardiac or thoracic surgery requiring endotracheal intubation.
• Patients without consciousness impairment, able to cooperate with the investigation.
• Patients or their legal guardians informed about the study's purpose, methodology, and content, with signed informed consent forms.

You may not qualify if:

• Patients with pre-existing oral conditions (e.g., xerostomia, oral mucosal lesions) prior to mechanical ventilation.
• Patients with a history of radiotherapy, chemotherapy, or corticosteroid use before surgery.
• Patients experiencing intraoperative mortality.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Xinhua hospital

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Aimin Shao, master

CONTACT

18796080248; 1224103064@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: May 13, 2025
• Study Start: May 25, 2025
• Primary Completion: March 25, 2026
• Study Completion: March 25, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)