Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04770259
Status:
COMPLETED
Last Update Posted:
2023-12-14
First Post:
2021-02-15
Brief Title:
Pre-surgical Protocol for Frail Elderly People in Order to Reduce Hospitalization Days APOPM
Sponsor:
Pontificia Universidad Catolica de Chile
Organization:
Pontificia Universidad Catolica de Chile
Study Overview
Official Title:
Generation of a Pre-surgical Conditioning Protocol for Frail Elderly People in Order to Reduce Hospitalization Days
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APOPM
Brief Summary:
Elderly people EP have increased as well as life expectancy at birth In Chile there are more than 2 million 800 thousand EP which corresponds to 16 of the Chilean population
The EP have a higher disease burden and mortality when facing surgery and in the postoperative period
Thus this population frequently has longer hospital stays due to its degree of fragility surgical complications or decompensation of its underlying pathologies directly affecting health care systems
An inadequate preparation of the EP prior to surgery determined that the requirements of in-hospital as well as out-of-hospital care are extended with the consequent which entails a higher cost in health
Current research underestimates the conditions of frailty and dependence in the EP In addition it is not routinely evaluated prior to surgery as well as nutritional metabolic cognitive status and or delirium screening is performed
There are accelerated recovery programs which relate their interventions to specific pathologies however the age of the person is not taken into account
Surgical pre-habilitation interventions in the EP usually focus their efforts on physical and cardiovascular aspects not including an integrative pre-surgical evaluation
Based on the foregoing a prospective interventional longitudinal and randomized study has been proposed in a population of the EP who will undergo elective urology and coloproctology surgeries in two university hospitals private and public
The objective of this study is to evaluate how the implementation of a timely pre-surgical conditioning APO protocol for frail elderly people reduces the days of hospital stay
The APO considers the most relevant aspects of physical and cardiovascular pre-habilitation in addition to contemplating evaluations of frailty dependence cognitive status screening for delirium nutritional and metabolic
The EP have a higher disease burden and mortality when facing surgery and in the postoperative period
Thus this population frequently has longer hospital stays due to its degree of fragility surgical complications or decompensation of its underlying pathologies directly affecting health care systems
An inadequate preparation of the EP prior to surgery determined that the requirements of in-hospital as well as out-of-hospital care are extended with the consequent which entails a higher cost in health
Current research underestimates the conditions of frailty and dependence in the EP In addition it is not routinely evaluated prior to surgery as well as nutritional metabolic cognitive status and or delirium screening is performed
There are accelerated recovery programs which relate their interventions to specific pathologies however the age of the person is not taken into account
Surgical pre-habilitation interventions in the EP usually focus their efforts on physical and cardiovascular aspects not including an integrative pre-surgical evaluation
Based on the foregoing a prospective interventional longitudinal and randomized study has been proposed in a population of the EP who will undergo elective urology and coloproctology surgeries in two university hospitals private and public
The objective of this study is to evaluate how the implementation of a timely pre-surgical conditioning APO protocol for frail elderly people reduces the days of hospital stay
The APO considers the most relevant aspects of physical and cardiovascular pre-habilitation in addition to contemplating evaluations of frailty dependence cognitive status screening for delirium nutritional and metabolic
Detailed Description:
A prospective interventional longitudinal and randomized study has been proposed in a population of the EP who will undergo elective urology and coloproctology surgeries in two university hospitals Red de Salud UC-Christus and Hospital Clinico La Florida Both based on Santiago de Chile
The objective of this study is to evaluate how the implementation of a timely pre-surgical conditioning APO protocol for frail elderly people reduces the days of hospital stay
PM will be screened according to co-morbidities degree of frailty and dependence This procedure will be carried out by a trained register nurse RN from the team at each center who through a random system will enter 50 of the patients to the APO protocol intervention and the other 50 to the standard protocol of each institution After that the RN will measure nutritional and cognitive status drugs and alcohol consume and will take the protocol blood samples in the first evaluation two to three days after receiving an order for surgery for the physician
The APO considers the evaluations for a geriatric team physical therapist team and nutritionist team in order to find out the most relevant aspects of physical cardiovascular geriatric syndromes cognitive status nutritional and metabolic status
physical therapist team and nutritionist team they will prepare to the EP to surgery with physical cardiovascular and dietary protocols adjusted to the patient for the time of 4 to 5 weeks before surgery
Upon admission of hospitalization for surgery the RN in each of the two hospitals will evaluate the state of frail and dependence nutritional and cognitive status drugs and alcohol consume and delirium status in which the patients of both groups arrive
The analgesia and anesthesia of all patients in both groups control and intervention will be standardized to reduce confounding associated with intra- and postoperative anesthesia and analgesia
The registered nurse will follow the patient throughout the in-hospital process and via telemedicine or face-to-face will interview patients one month second month and third month after discharge in search of possible problems associated with the peri-operative process
The objective of this study is to evaluate how the implementation of a timely pre-surgical conditioning APO protocol for frail elderly people reduces the days of hospital stay
PM will be screened according to co-morbidities degree of frailty and dependence This procedure will be carried out by a trained register nurse RN from the team at each center who through a random system will enter 50 of the patients to the APO protocol intervention and the other 50 to the standard protocol of each institution After that the RN will measure nutritional and cognitive status drugs and alcohol consume and will take the protocol blood samples in the first evaluation two to three days after receiving an order for surgery for the physician
The APO considers the evaluations for a geriatric team physical therapist team and nutritionist team in order to find out the most relevant aspects of physical cardiovascular geriatric syndromes cognitive status nutritional and metabolic status
physical therapist team and nutritionist team they will prepare to the EP to surgery with physical cardiovascular and dietary protocols adjusted to the patient for the time of 4 to 5 weeks before surgery
Upon admission of hospitalization for surgery the RN in each of the two hospitals will evaluate the state of frail and dependence nutritional and cognitive status drugs and alcohol consume and delirium status in which the patients of both groups arrive
The analgesia and anesthesia of all patients in both groups control and intervention will be standardized to reduce confounding associated with intra- and postoperative anesthesia and analgesia
The registered nurse will follow the patient throughout the in-hospital process and via telemedicine or face-to-face will interview patients one month second month and third month after discharge in search of possible problems associated with the peri-operative process
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None