Non-pharmacological Prevention of POD in Frailty Elderly Undergoing Elective Surgery Applied by Nursing Teams

NCT05993754 | Recruiting DMC

• 1 other identifier: 220727001
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The increase in the population over 60 years of age who could receive surgery due to changes in life expectancy and advances in surgical and anesthetic techniques. Likewise, elderly people (EP) may have a higher risk of postoperative morbidity and mortality compared to young people, with frailty being one of the risk factors that increases adverse outcomes in this period and increases the probability of developing syndromes such as postoperative delirium (POD). Assessment of frailty in EP prior to surgery is not routine, so it is unknown how many frail and/or pre-frail EP undergo surgery in health care systems. There is an association between being frail and developing greater delirium and/or postoperative cognitive deficit, which in summary translates into an increase in perioperative morbidity and mortality. For the prevention of POD, there are pharmacological and non-pharmacological measures that seek to promote orientation with respect to their environment and make it as familiar as possible, stimulate early aspects of memory and thinking skills, as well as promote sleep using environmental hygiene measures. In Chile, protocols of non-pharmacological measures have been proposed by occupational therapy teams, which have had positive results in reducing POD in frail elderly patients. These measures are temporal-spatial reorientation, physical mobilization, correction of sensory deficits, environmental management, sleep protocol, and reduction of anticholinergic drugs with statistically significant results in the reduction of POD. In accordance with the above, the objective of this study is to evaluate the impact of non-pharmacological measures applied by the nursing team in reducing the incidence of POD during the post-surgical period in fragile and pre-fragile EP undergoing elective non-cardiac surgeries. It is expected that in the end, frail and pre-frail EP who receive non-pharmacological interventions by the nursing team will present a lower incidence of POD at 24 hours compared to those who receive traditional care.

Conditions

Frail Elderly Syndrome; Primary Prevention; Postoperative Delirium; Frailty

Keywords

Delirium; Non-pharmacological; Elderly; Frailty; Nursing; Postoperative

Outcome Measures

Primary Outcomes (1)

• Postoperative delirum (POD)

  Neurocognitive syndrome can occur from anywhere after anesthesia measure using the Confusion assessment method (CAM). For a diagnosis of delirium by CAM, the patient must display presence of acute onset and fluctuating discourse and Inattention, and either disorganized thinking or Altered level of consciousness (positive CAM), otherwise, the result is negative (negative CAM).

  : 10 minutes, 60 minutes, 120 minutes, 720 minutes and 1440 minutes after anesthesia

Secondary Outcomes (12)

• Frailty _FRAIL

  Pre Anesthesia period at same day of the surgery

• Frailty_CFS

  Pre Anesthesia period at same day of the surgery

• Screening of Cognitive impairment_MiniCog

  Pre Anesthesia period at same day of the surgery

• Possible Cognitive impairment_MoCA

  Pre Anesthesia period at same day of the surgery

• Risk of anesthesia

  Pre Anesthesia period at same day of the surgery

Study Arms (2)

Intervention group

EXPERIMENTAL

Frail and pre-frail elderly people over 65 years of age who underwent elective non-cardiac surgeries who receive non-pharmacological interventions by the nursing team

Other: Non-pharmacological intervention

Control group

NO INTERVENTION

Frail and pre-frail elderly people over 65 years of age undergoing elective non-cardiac surgeries who will receive traditional care.

Interventions

Non-pharmacological intervention OTHER

The intervention consists of six main elements: Correction of sensory deficits: Before surgery, the use of glasses, hearing aids and/or removable dental prostheses will be allowed, which will be removed before starting anesthesia in the emergency room. After surgery, they will be delivered back to the user. Reorientation: In the postoperative period, the person will be informed where they are and the visit of the companion will be coordinated. Early mobilization: A protocolized mobilization routine will be applied according to pain, state of consciousness, risk of thromboembolic disease and risk of falls. Environmental management: You will be shown the time on a clock, it will reinforce the idea of the place where you are and that you can count on the team in case you need assistance. Sleep protocol: The elderly person who does not want or cannot perform the mobilization routine, non-pharmacological sleep will be privileged. Reduction of anticholinergic drugs

Intervention group

Eligibility Criteria

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

You may qualify if:

• Patients older than 65 years
• Elective non-cardiac surgery
• General anesthesia with Bilateral BIS electroencephalographic monitoring or SedLine
• ASA I, II or III.

You may not qualify if:

• Neurosurgical patients
• History of alcohol and/or drug abuse
• History of recreational psychoactive drug use
• Allergy to anesthetic drugs.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Pontificia Universidad Catolica de Chile

Santiago, Santiago Metropolitan, 8330024, Chile

RECRUITING

MeSH Terms

Conditions

Emergence Delirium; Frailty; Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• Victor Contreras, MSN

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victor Contreras, MSN

CONTACT

+56955049217; vecontre@uc.cl

Karen Azagra, BcS

CONTACT

+56955049217; karen.azagra@uc.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: After signed informed consent at the preoperative unit and during the post anesthesia unit care
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control group and intervention group

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 15, 2023
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-06

Locations

CL (1)