NCT05993754 Non-pharmacological Prevention of POD in Frailty Elderly Undergoing Elective Surgery Applied by Nursing Teams
| NCT ID | NCT05993754 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pontificia Universidad Catolica de Chile |
| Condition | Frail Elderly Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2024-04-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Patients older than 65 years * Elective non-cardiac surgery * General anesthesia with Bilateral BIS electroencephalographic monitoring or SedLine * ASA I, II or III. Exclusion Criteria: * Neurosurgical patients * History of alcohol and/or drug abuse * History of recreational psychoactive drug use * Allergy to anesthetic drugs.
Contact & Investigator
Victor Contreras, MSN
PRINCIPAL INVESTIGATOR
Pontificia Universidad Catolica de Chile
Frequently Asked Questions
Who can join the NCT05993754 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Frail Elderly Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05993754 currently recruiting?
Yes, NCT05993754 is actively recruiting participants. Contact the research team at vecontre@uc.cl for enrollment information.
Where is the NCT05993754 trial being conducted?
This trial is being conducted at Santiago, Chile.
Who is sponsoring the NCT05993754 clinical trial?
NCT05993754 is sponsored by Pontificia Universidad Catolica de Chile. The principal investigator is Victor Contreras, MSN at Pontificia Universidad Catolica de Chile. The trial plans to enroll 400 participants.