2014-08-012024-05-13https://scholars.lib.ntu.edu.tw/handle/123456789/646149摘要：醫療技術發展迅速，越來越多50 歲以上病患接受氣管內管插管治療。拔管後的吞嚥困難有高達3‐62%的盛行率，常導致延後由口進食等營養困境。加上原本老化所帶來的唾液分泌減少、口咽肌肉力量下降、延遲性吞嚥等生理變化，使得長期插管中老年病患的拔管後吞嚥困難更加常見，對於後續營養狀況的恢復帶來嚴重的影響。因此，本計畫將針對內科加護病房，口咽氣管內管插管超過四十八小時的中老年病患(>50歲)，於成功拔管後的二十一日內，陸續評估其吞嚥及營養功能，以瞭解插管對吞嚥、營養功能的影響，藉此發展適切的口腔認知護理介入並評估其功效。研究將以兩階段進行：階段一：前瞻、縱貫性觀察調查，藉以發展實證性口腔認知護理模式(2012.8-2014.6)本階段採連續取樣，預計收案140位內科加護病房中老年病患，在其拔除氣管內管四十八小時內、拔管後七日、十四日、及二十一日，對其相關危險因子【包括認知功能、呼吸型態、喉部損傷情況(如水腫、潰瘍、肉芽腫、聲帶活動異常等)、舌頭及唇部肌肉力量、及口腔狀態】和結果變項【包括吞嚥困難主客觀症狀、一般口腔健康、由口進食及營養狀況】進行前瞻性觀察，藉以確認拔管後吞嚥困難的危險因子並發展最適於長期插管拔管後中老年病患使用之實證護理介入模式。階段二：隨機試驗檢視口腔認知護理在改善拔管後吞嚥及營養困境之效能(2014.7-2016.7)此階段採隨機、單盲(single blind)的臨床試驗(Randomized controlled trials)，同樣在四個時間點：拔管四十八小時內(T0)、拔管後七日(T1)、十四日(T2)、及二十一日後(T3)作資料收集。在baseline (T0) 資料收集後將收案之母群體隨機分配為實驗與對照兩組。實驗組增加研究中制訂之口腔認知護理介入(含口腔清潔，口咽功能刺激，及認知刺激)持續至出院，對照組則接受常規照護。研究之結果變項包括【吞嚥損傷主客觀症狀、一般口腔健康、進食及營養狀況】等。預計兩組收案共138名，研究進行為期兩年。資料將以 SAS統計軟體，根據臨床試驗規範及intention-to-treat 原則分析及報告研究結果。分析將採Generalized Estimating Equations來判別實驗組及對照組組在結果變項發生及改變的差異，以提出此一口腔認知護理模式在減少拔管後吞嚥困難、改善一般口腔健康，進而改善長期插管拔管後中老年病患進食、營養狀態之效能。<br> Abstract: Swallowing and nutritional complications after endotracheal extubation occurred commonly and affected patients across all diagnostic categories, particularly for patients older than 50 years. Because oral intake is an important component of patient recovery after critical illness, the aim of this study is to develop and evaluate an oral cognitive care protocol for the reduction of swallowing and nutritional complications in older patients after prolonged endotrachel intubation. In keeping with previous research, we defined prolonged endotrachel intubation as 48 hours and longer.Phase I: Given the dearth of data on these outcomes of interest, a prospective observational study will be conducted to assess the incidence and risk factors of swallowing and nutritional complications among patients aged 50 years and older following endotracheal extubation. Swallowing complications will be assessed at four points in time, 48 hours within extubation (T0), 7 days (T1), 14 days (T2), and 21 days (T3) postextubation. Fiberoptic Endoscopic Evaluation of Swallowing (FEES), Repetitive Saliva Swallowing Test (RSST), Sub-mental Ultrasonography (SUG), 3 steps Swallowing Screen (3-SSS), and Swallowing Questionnaire (SQ) will be used at different time points to better assess swallowing complications. Based on power analysis, 140 participants will be enrolled. Findings will add to develop an evidence-based oral cognitive care protocol.Phase II: A prospective, single-blind, one-center randomized controlled trial (RCT) using a computer generalized randomization list will be conducted to test the effects of this newly developed oral cognitive care protocol in reducing swallowing complications (measured by FEES, RSST, SUG, 3-SSS, & SQ), improving oral health (measured by oral assessment guide, and general oral health assessment), and promoting nutritional status (measured by oral intake level, mini-nutritional assessment, and weight changes) in patients intubated for more than 48 hours. Blinded raters will assess patients 21 days following endotracheal extubation at 4 points in time (T0-T3).Patients≧50 years who had intubated≧48 hours, excluding patients with neurological and structural deficits, will be recruited consecutively from 3 intensive medical care units at NTU hospital. Based on power analysis, a sample size of 138 is sufficient to reach 80% power of analysis. Simple random assignment to the experimental and usual care group will be performed. Strict adherence to the resulting randomization will be ensured.The intervention consisted of a daily oral cognitive care protocol on two core components, oral care (cleaning and oral function stimulation) and cognitive stimulation. Usual care consisted of standard hospital services and the same physicians provide care to patients in both experimental and usual care groups.Data will be analyzed using the SAS package. The intention-to-treat principle will be used. Generalized Estimating Equation will be performed to test the intervention effect. This study will cover not only “whether” but “how” to intercede postextubation swallowing and nutritional complications. It is also the first RCT study to test the effect of oral cognitive care in reducing swallowing and nutritional complications in older patients after endotracheal extubation.