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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorPontificia Universidad Catolica de Chile

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Patients older than 65 years

Elective non-cardiac surgery

General anesthesia with Bilateral BIS electroencephalographic monitoring or SedLine

ASA I, II or III.

Disqualifiers

Neurosurgical patients

History of alcohol and/or drug abuse

History of recreational psychoactive drug use

Allergy to anesthetic drugs.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Non-pharmacological intervention

    Other intervention

    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

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

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).

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

Secondary outcomes

1

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).

Time frame
Pre Anesthesia period at same day of the surgery
2

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.

Time frame
Pre Anesthesia period at same day of the surgery
3

Screening of Cognitive impairment_MiniCog

Using Mini-Cog Score: 0 to 2 indicates possible cognitive disorder; 3 to 5 indicates no cognitive disorder.

Time frame
Pre Anesthesia period at same day of the surgery
4

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.

Time frame
Pre Anesthesia period at same day of the surgery

Other outcomes

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