Cognitive and Physical Optimization in Prevention of Postoperative Cognitive Deficit in Elderly With Lung Resection

Официальное название

Effects of Preoperative Cognitive and Physical Optimization in the Prevention of Postoperative Cognitive Deficit in Elderly Patients With Lung Resection

Обзор

Postoperative cognitive deficit and its connection with surgery and general anesthesia were first mentioned in the literature in 1955 by Bradford. Cognitive disorders in the postoperative period are postoperative delirium (POD) and postoperative cognitive dysfunction (POCD). POD is an acute dysfunction in cognition, which did not exist preoperatively. Attention deficit disorder is the main symptom of POD and refers to the inability to direct, focus, maintain, or shift attention. Memory impairment, disorientation, or perceptual disturbances may also be present. Cognitive capacity changes in POD patients develop and fluctuate in the first few days after surgery. Unlike POD, there is no formal definition for POCD. Based on data from the existing literature, it is defined as newly diagnosed cognitive deterioration that occurs after surgery. The diagnosis of POCD should be based on pre- and postoperative screening with appropriate psychometric tests. Risk factors for the development of POCD include those related to the surgical procedure, anesthesia, or the patient himself. Compared to less invasive and shorter operations, there is a higher risk of developing POCD after major, invasive, and long-term operations. Additional risk factors are intraoperative (intraoperative bleeding, perioperative transfusion treatment, hypotension) and postoperative complications (respiratory insufficiency, pneumonia, atelectasis, bronchospasm, bronchopleural fistula, and pulmonary edema). Presurgical optimization (Prehabilitation) is a widespread concept that aims to improve the general condition of the patient or optimize comorbidities before major surgery. Prehabilitation is primarily focused on improving physical ability and nutritional status, but it is developing in the direction of a multimodal approach that includes measures to reduce stress and anxiety. Psychological factors are increasingly recognized as an essential element of prehabilitation and are often added to prehabilitation programs. Older patients, who meet the diagnostic criteria for frailty and are at risk of developing postoperative complications such as cognitive function disorders are increasingly undergoing lung resection. These complications can affect the outcome and speed of postoperative recovery.

Подробное описание

After setting the indication for operative treatment, patients who meet the criteria for inclusion in the study, after signing the informed consent, will be randomized into two groups:

1. The first group (intervention) where the patient will receive preoperative cognitive stimulation and physical therapy for one month before surgical treatment. 2. The second group (control) where patients receive standard treatment. Randomization will be performed using computer randomization by doctors who do not participate in the testing and preoperative preparation of the patient.

Patients included in the first group will be subjected to psychological testing and preoperative training to receive tasks to improve cognitive functions. This technique, known as presurgical cognitive optimization, involves several standardized tests of cognitive stimulation through the cognitive training application (Cognifit) on a phone or tablet that patients use three times a week for 20 minutes for a month (from inclusion in the study to scheduled surgery). Also, after consultation with a physiatrist and testing for the presence of weakness syndrome as well as other tests related to the mobility and physical condition of patients, preoperative physical therapy (breathing exercises, walking, climbing stairs) will be carried out in this group of patients. Patients from this group, in addition to the exercise program they carry out for physical preparation before surgery, receive preoperative education on techniques and exercises that they will do immediately postoperatively in bed. Patients will keep a diary of preoperative activities that will be controlled by researchers.

Patients from the second group will be tested perioperatively with cognitive and weakness syndrome tests and other physiatry tests, but without cognitive intervention and physical therapy, they will be referred for surgery.

Вмешательства

• Поведенческое Cognitive training, CogniFit App
  A patient will receive preoperative cognitive stimulation and physical therapy for one month before surgical treatment.

Первичные конечные точки

• Postoperative cognitive dysfunction [Срок оценки: From 1 month preoperatively (schedulling patient for surgery) until 30th postoperative day]
• Perioperative depression and anxiety [Срок оценки: From 1 month preoperatively (schedulling patient for surgery) until 30th postoperative day]
• Postoperative delirium [Срок оценки: First postoperative day]
• Functional status and postoperative recovery [Срок оценки: From 1 month preoperatively (schedulling patient for surgery) until 30th postoperative day]
• Functional status and postoperative recovery [Срок оценки: From 1 month preoperatively (schedulling patient for surgery) until 30th postoperative day]
• Postoperative recovery [Срок оценки: From 1st til 5th postoperative day]
• Functional status and postoperative recovery [Срок оценки: From 1 month preoperatively (schedulling patient for surgery) until 30th postoperative day]

Вторичные конечные точки (3)

• Overall outcome: Complication rate [Срок оценки: From surgery until 30th postoperative day]
• Overall outcome: Morbidity [Срок оценки: From surgery until 30th postoperative day]
• Overall outcome: Mortality [Срок оценки: From surgery until 30th postoperative day]

Критерии участия

Критерии включения

• Older than 60 years
• Elective lung resection operations
• Patients who can use a phone or tablet
• Patients who agreed to participate in the study
• Clinical scale of weakness less than 6
• The American Society of Anesthesiologists (ASA) status I, II, III, IV

Критерии исключения

• Under 60 years of age
• Significant psychiatric comorbidity (schizophrenia, depression, alcoholism)
• Significant neurological comorbidity (dementia, cerebrovascular insult in the last 6 months, parkinsonism)
• Patient's refusal to participate in the study
• The inability of the patient to use a tablet or phone
• The American Society of Anesthesiologists (ASA) status V and VI
• Clinical weakness scale 6 and above

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Сербия · 1 центр

• Military Medical Academy — Belgrade

Публикации

• BEDFORD PD. Adverse cerebral effects of anaesthesia on old people. Lancet. 1955 Aug 6;269(6884):259-63. doi: 10.1016/s0140-6736(55)92689-1. No abstract available. PMID 13243706
• Strom C, Rasmussen LS, Sieber FE. Should general anaesthesia be avoided in the elderly? Anaesthesia. 2014 Jan;69 Suppl 1(Suppl 1):35-44. doi: 10.1111/anae.12493. PMID 24303859
• Needham MJ, Webb CE, Bryden DC. Postoperative cognitive dysfunction and dementia: what we need to know and do. Br J Anaesth. 2017 Dec 1;119(suppl_1):i115-i125. doi: 10.1093/bja/aex354. PMID 29161395
• Carli F. Prehabilitation for the Anesthesiologist. Anesthesiology. 2020 Sep;133(3):645-652. doi: 10.1097/ALN.0000000000003331. No abstract available. PMID 32358253
• Daiello LA, Racine AM, Yun Gou R, Marcantonio ER, Xie Z, Kunze LJ, Vlassakov KV, Inouye SK, Jones RN, Alsop D, Travison T, Arnold S, Cooper Z, Dickerson B, Fong T, Metzger E, Pascual-Leone A, Schmitt EM, Shafi M, Cavallari M, Dai W, Dillon ST, McElhaney J, Guttmann C, Hshieh T, Kuchel G, Libermann T, Ngo L, Press D, Saczynski J, Vasunilashorn S, O'Connor M, Kimchi E, Strauss J, Wong B, Belkin M, A PMID 31166241
• Wang W, Wang Y, Wu H, Lei L, Xu S, Shen X, Guo X, Shen R, Xia X, Liu Y, Wang F. Postoperative cognitive dysfunction: current developments in mechanism and prevention. Med Sci Monit. 2014 Oct 12;20:1908-12. doi: 10.12659/MSM.892485. PMID 25306127
• Sugimoto T, Arai H, Sakurai T. An update on cognitive frailty: Its definition, impact, associated factors and underlying mechanisms, and interventions. Geriatr Gerontol Int. 2022 Feb;22(2):99-109. doi: 10.1111/ggi.14322. Epub 2021 Dec 9. PMID 34882939
• Gracie TJ, Caufield-Noll C, Wang NY, Sieber FE. The Association of Preoperative Frailty and Postoperative Delirium: A Meta-analysis. Anesth Analg. 2021 Aug 1;133(2):314-323. doi: 10.1213/ANE.0000000000005609. PMID 34257192

Идентификаторы

NCT: NCT06339268 · MMABelgrade

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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