Frail Elderly SyndromeNPPODNCT05993754
Non-pharmacological Prevention of POD in Frailty Elderly Undergoing Elective Surgery Applied by Nursing Teams
A study testing Non-pharmacological intervention in people with Frail Elderly Syndrome and Primary Prevention, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly Syndrome, Primary Prevention, Postoperative Delirium
- What is being tested?
- Non-pharmacological intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChile
- Study dates
- 1 Apr 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients older than 65 years
- Elective non-cardiac surgery
- General anesthesia with Bilateral BIS electroencephalographic monitoring or SedLine
- ASA I, II or III.
Who cannot join
- Neurosurgical patients
- History of alcohol and/or drug abuse
- History of recreational psychoactive drug use
- Allergy to anesthetic drugs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan, 8330024
Victor Contreras, MSN, 981895232, vecontre@uc.cl
About this study
Official title: Impact of Non-pharmacological Measures Applied by the Nursing Team in Reducing the Incidence of Postoperative Delirium During the Postoperative and 24hr After Surgery in Frail Elderly Undergoing Elective Non-cardiac Surgeries.
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).
Read more
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.
Read the detailed description
Participants will correspond to frail and pre-frail people over 65 years of age who undergo elective non-cardiac surgery that requires general anesthesia and who attend the UC-Christus Clinical Hospital.
Frailty instruments (FRAIL scale) and Clinical Frailty Scale (CFS) will be applied, together with a preoperative cognition test (MiniCog; in case of presenting an altered result, the Montreal Cognitive Assessment, MoCA instrument will be applied), the delirium screening test (Delirium Triage Screen, DTS; in case of presenting an altered result, the Confusion Assessment Method instrument will be applied. d, CAM). Then, the participants will be randomized into two groups:
- A first group to which a protocol of non-pharmacological interventions implemented by the nursing team will be applied to prevent post-surgical delirium
- A second control group that will only receive traditional care. The users of the first group who use glasses, hearing aids and/or removable dental prostheses will move from the pre-operative unit room to the surgical ward with these elements, which will be delivered to their caregiver or companion after the safety break and before starting anesthesia inside the ward room where they will be operated on.
Both groups will undergo standard monitoring (ECG, NIBP, SatO2) and anesthesia will be guided using frontal EEG (SedLine or bilateral BIS). During the intraoperative period, an effort will be made to maintain a Mean Blood Pressure ± 20% of baseline and to keep the patient normothermic.
In the postoperative stage, therapeutic activities of cognitive stimulation and socialization will be carried out where temporal-spatial information will be delivered, the visit of the companion will be coordinated, a protocolized mobilization routine will be carried out considering pain, state of consciousness, thromboembolic risk and risk of falls. In the event that she does not want or cannot carry out the protocolized mobilization routine, non-pharmacological sleep will be privileged.
One hour after the patient's admission to the recovery unit, a delirium evaluation will be performed using CAM by personnel other than the one who performed the non-pharmacological measures. Two hours later, the non-pharmacological measures will be reinforced and later a new evaluation of delirium will be applied using CAM.
An evaluation of delirium will be carried out during the morning by means of CAM 24 hours after the admission of the patient to the recovery unit by a person other than the nursing team, who has not applied the protocol of non-pharmacological measures.
If the elderly person is still hospitalized, a final delirium evaluation will be carried out by means of CAM during the afternoon (24 hours after admission to the recovery unit).
In the event that the person presents CAM (+), the application of non-pharmacological measures will be evaluated with the treating team and the respective interconsultation will be processed with the geriatric team of the study.
- Being tested
- Non-pharmacological intervention
- Keywords
- Delirium, Non-pharmacological, Elderly, Frailty, Nursing, Postoperative
- Medical subject headings
- Emergence Delirium, Frailty, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-pharmacological interventionOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: : 10 minutes, 60 minutes, 120 minutes, 720 minutes and 1440 minutes after anesthesia
Secondary outcomes (12)
Frailty _FRAIL
Frailty elderly measure by FRAIL Scale. It assesses 5 components: fatigue, resistance, ambulation, illnesses, and loss of weight. The score goes from 0 to 5 and represents the state of health and each component is worth 1 point, where it is recorded as robust (0), pre-frail (1-2) and fragile (3-5).
Measured: Pre Anesthesia period at same day of the surgery
Frailty_CFS
Frailty elderly measure by Clinical Frailty Scale (CFS). Present a score from 1 (very fit) to 9 (terminally ill) is given based on the descriptions and pictographs of activity and functional status.
Measured: Pre Anesthesia period at same day of the surgery
Screening of Cognitive impairment_MiniCog
Using Mini-Cog Score: 0 to 2 indicates possible cognitive disorder; 3 to 5 indicates no cognitive disorder.
Measured: Pre Anesthesia period at same day of the surgery
Possible Cognitive impairment_MoCA
Measure by Montreal Cognitive Assessment (MoCA) test The cut-off point for MCI-a is <21 and for mild dementia <20. If the person has less than 12 years of schooling, 1 point is added.
Measured: Pre Anesthesia period at same day of the surgery
Risk of anesthesia
Using the American Society of Anesthesiologists (ASA) classification. Categorize the patient's risk of undergoing any procedure that requires anesthesia, allowing to assess their physiological state and systemic diseases. The ASA score is based on five classes (I to V).
- Patient is a completely healthy fit patient. II. Patient has mild systemic disease. III. Patient has severe systemic disease that is not incapacitating. IV. Patient has incapacitating disease that is a constant threat to life. V. A moribund patient who is not expected to live 24 hour with or without surgery.
Measured: Pre Anesthesia period at same day of the surgery
Type of surgery
Classification of surgery by specialty
Measured: Pre Anesthesia period at same day of the surgery
Educational level of chile
Using the number of years of formal learning
Measured: Pre Anesthesia period at same day of the surgery
Type of Anesthesia
Classification type of anesthesia (Total Intravenous anesthesia, Total inhalation anesthesia and/or other)
Measured: Up to 30 minutes after the end of the surgery
Electroencephalogram monitoring during the anesthesia
Measure by electroencephalogram (EEG) monitor (SedLine or BIS). From the start of anesthesia to the end of it.
Measured: Up to 30 minutes after the end of the surgery
Type of drugs during anesthesia
According of classification type of anesthesia, amount of total drugs (mg, mcg, %etgas and/or other) General anesthesia (gas-based anesthesia or total intravenous anesthesia)
Measured: Up to 30 minutes after the end of the surgery
Postoperative Pain
Measure by Numerical Rating Scale (NRS) pain The patient indicates the degree of pain on a scale of 0-10, where 0 is no pain and 10 is the worst pain imaginable.
Measured: 10 minutes, 60 minutes, 120 minutes, 720 minutes and 1440 minutes after anesthesia
Positive POD Positive CAM: presence of post-operative delirium (POD) Negative CAM:. absence of postoperative delirium (POD)
Measure by type of pharmacological measure by type of pharmacological management
Measured: 720 minutes and 1440 minutes after anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start1 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group and intervention group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victor Contreras, MSN, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993754
- Sponsor's protocol ID
- 220727001
- Acronym
- NPPOD
- Status last verified
- Jun 2025
- First submitted
- 27 Jul 2023
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Non-pharmacological Measures Applied by the Nursing Team in Reducing the Incidence of Postoperative Delirium During the Postoperative and 24hr After Surgery in Frail Elderly Undergoing Elective Non-cardiac Surgeries.
- ClinicalTrials.gov ID
- NCT05993754
- Acronym / sponsor ID
- NPPOD / 220727001
- Keywords
- Delirium, Non-pharmacological, Elderly, Frailty, Nursing, Postoperative
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will correspond to frail and pre-frail people over 65 years of age who undergo elective non-cardiac surgery that requires general anesthesia and who attend the UC-Christus Clinical Hospital.
Frailty instruments (FRAIL scale) and Clinical Frailty Scale (CFS) will be applied, together with a preoperative cognition test (MiniCog; in case of presenting an altered result, the Montreal Cognitive Assessment, MoCA instrument will be applied), the delirium screening test (Delirium Triage Screen, DTS; in case of presenting an altered result, the Confusion Assessment Method instrument will be applied. d, CAM). Then, the participants will be randomized into two groups:
- A first group to which a protocol of non-pharmacological interventions implemented by the nursing team will be applied to prevent post-surgical delirium
- A second control group that will only receive traditional care. The users of the first group who use glasses, hearing aids and/or removable dental prostheses will move from the pre-operative unit room to the surgical ward with these elements, which will be delivered to their caregiver or companion after the safety break and before starting anesthesia inside the ward room where they will be operated on.
Both groups will undergo standard monitoring (ECG, NIBP, SatO2) and anesthesia will be guided using frontal EEG (SedLine or bilateral BIS). During the intraoperative period, an effort will be made to maintain a Mean Blood Pressure ± 20% of baseline and to keep the patient normothermic.
In the postoperative stage, therapeutic activities of cognitive stimulation and socialization will be carried out where temporal-spatial information will be delivered, the visit of the companion will be coordinated, a protocolized mobilization routine will be carried out considering pain, state of consciousness, thromboembolic risk and risk of falls. In the event that she does not want or cannot carry out the protocolized mobilization routine, non-pharmacological sleep will be privileged.
One hour after the patient's admission to the recovery unit, a delirium evaluation will be performed using CAM by personnel other than the one who performed the non-pharmacological measures. Two hours later, the non-pharmacological measures will be reinforced and later a new evaluation of delirium will be applied using CAM.
An evaluation of delirium will be carried out during the morning by means of CAM 24 hours after the admission of the patient to the recovery unit by a person other than the nursing team, who has not applied the protocol of non-pharmacological measures.
If the elderly person is still hospitalized, a final delirium evaluation will be carried out by means of CAM during the afternoon (24 hours after admission to the recovery unit).
In the event that the person presents CAM (+), the application of non-pharmacological measures will be evaluated with the treating team and the respective interconsultation will be processed with the geriatric team of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Control group and intervention group
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Non-pharmacological interventionFrail 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 |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients older than 65 years
- Elective non-cardiac surgery
- General anesthesia with Bilateral BIS electroencephalographic monitoring or SedLine
- ASA I, II or III.
Key exclusion criteria (4 listed)
- Neurosurgical patients
- History of alcohol and/or drug abuse
- History of recreational psychoactive drug use
- Allergy to anesthetic drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-pharmacological interventionThe 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 | Other | Intervention group |
Primary outcome
Postoperative delirum (POD)
Time frame: : 10 minutes, 60 minutes, 120 minutes, 720 minutes and 1440 minutes after anesthesia
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).
12 secondary outcomes
Frailty _FRAIL
Time frame: Pre Anesthesia period at same day of the surgery
Frailty_CFS
Time frame: Pre Anesthesia period at same day of the surgery
Screening of Cognitive impairment_MiniCog
Time frame: Pre Anesthesia period at same day of the surgery
Possible Cognitive impairment_MoCA
Time frame: Pre Anesthesia period at same day of the surgery
Risk of anesthesia
Time frame: Pre Anesthesia period at same day of the surgery
Type of surgery
Time frame: Pre Anesthesia period at same day of the surgery
Educational level of chile
Time frame: Pre Anesthesia period at same day of the surgery
Type of Anesthesia
Time frame: Up to 30 minutes after the end of the surgery
Electroencephalogram monitoring during the anesthesia
Time frame: Up to 30 minutes after the end of the surgery
Type of drugs during anesthesia
Time frame: Up to 30 minutes after the end of the surgery
Postoperative Pain
Time frame: 10 minutes, 60 minutes, 120 minutes, 720 minutes and 1440 minutes after anesthesia
Positive POD Positive CAM: presence of post-operative delirium (POD) Negative CAM:. absence of postoperative delirium (POD)
Time frame: 720 minutes and 1440 minutes after anesthesia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victor Contreras, MSN principal investigator
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-pharmacological intervention in people with Frail Elderly Syndrome and Primary Prevention, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victor Contreras, MSN (+56955049217, vecontre@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative delirum (POD) (time frame: : 10 minutes, 60 minutes, 120 minutes, 720 minutes and 1440 minutes after anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.