วัสดุและวิธีการ การศึกษานี้ได้รับการอนุมัติ โดยคณะกรรมการตรวจสอบสถาบันท้องถิ่น และได้รับยกเว้นได้รับความยินยอมเป็นลายลักษณ์อักษรเนื่องจากธรรมชาติของการศึกษา ประชากรผู้ป่วย ในอนาคต randomized ควบคุมคดี 40 ติดต่อกันต้องการระบายอากาศเครื่องจักรกลในของเรา 8 เตียงผู้ใหญ่ทั่วไปฉุกเฉินสำหรับผู้ป่วย > 48 ชั่วโมงได้ถือสิทธิในการศึกษานี้ ผู้ป่วยอยู่ในช่วงในอายุจาก 18 ปี 90 ปี 2006 เดือนมกราคมถึง 2551 เมษายน ผู้ป่วยทั้งหมด มีประวัติทางเดินหายใจล้มเหลว-ure ต้อง MV การรุกรานมีสิทธิ์ ทั้งทางคลินิก และ hemodynamically มั่นคงรับ MV ในฉุกเฉินเนื่องจากการหายใจล้มเหลวเฉียบพลันกำเนิดแตกต่างกัน และตัดสินพร้อมที่จะรับการทดลอง extubation โดยแพทย์หลักของพวกเขา รวมอยู่ในการศึกษา ผู้ป่วยทั้งหมดถูกตรวจสอบความถี่ในการหายใจ อัตราการเต้นหัวใจ ชีพจร oxymetry และตรวจคลื่นไฟฟ้าหัวใจ และถูกควบคุม hemodynamically ต้นต้ว (รัศมี หรือ femoral) ศึกษาโพรโทคอล At the time of the inclusion in the study, all patients were mechanically ventilated via Servo 300 A (Siemens-Elema, Solna- Sweden) with a minimal ventilatory support (ie, sencronized intermittent mandatory ventilation (SIMV) rate ≤ 4 breaths/min) with no pressure support ventilation and with an FiO 2 of 40 %. During the study period, all patients were extubated following a standardized procedure; T-piece and CPAP trial was initi- ated when the following criteria were present: a significant improvement or resolution of the underlying reason for MV; adequate oxygenation (eg, pO 2 /fraction of inspired oxygen (FiO 2 ) >150; VT ≥ 5 mL/kg, requiring positive endexpiratory pressure (PEEP) ≤ 8 cm H 2 O; FiO 2 ≤ 0.4) and pH (eg, ≥ 7.35); require bronchial toilet less than twice in the 8 hrs preceding the assessment; body temperature below 38 °C, hemoglobin equal to or higher than 8 g/dL, cardiovascular pharmacologic therapy (including inotropic agents, vasodilators, and/or diuretics) considered ap- propriate by the primary physician when cardiac insufficiency and/or ischemia was known or suspected, systolic blood pres- sure, >90 mmHg, correction of electrolyte disorders, no intravenous sedatives (including benzodiazepines, opiates, propofol, and barbiturates) given for at least 48 h before the weaning trial, hemodynamic stability, full level of consciousness, and effective cough strength on command. The neurologic status was evaluated using the Glasgow coma scale, and 11 points were necessary for inclusion in the study. pO 2 /FiO 2 ratio could be inferior to 150 in patients with severe chronic hypoxemia (2,6,7). The ventilator mode used in all patients before beginning the study was SIMV, with a constant inspiratory flow pattern. In both groups, the FiO 2 was initially set withto the same level required before the breathing trial. For patients showing poor tolerance to the breathing trial, full ventilatory support was immediately recommenced. This was defined by a decrease in oxygen saturation to <90 % while requiring an FiO 2 >0.4; evi- dence of respiratory distress (respiratory rate ≥ 35/min for more than 5 mins, presence of respiratory acidosis (arterial pH <7.35 with pCO 2 >45 mmHg, in the presence of diaphoresis or thoraco- abdominal paradox), sustained increase in heart rate (>20 % baseline or >140 /min), or significant change in systolic blood pressure (>180 or <90 mmHg) (2, 3, 6, 7). Patients who toler- ated the spontaneous breathing trial underwent an immediate extubation and received supplemental oxygen via a facemask. If both groups were not tolerated by the patients, SIMV was used. Patients were randomly divided into two groups (n:20). Group T-piece received, 4 L/min oxygen, Group CPAP received, PEEP ≤ 5 cm H 2 O, FiO 2 ≤ 0.4. At the beginning of the study, duration of extubation and after 48 hours of extubation arterial blood samples were taken for blood gases analysis, also mean arterial pressure and heart rate were recorded. The primary outcome measure was successful weaning, defined as the ability to maintain spontaneous breathing for 48 hours after discontinuation of mechanically ventilation and extubation. Unsuccessful weaning was defined as the need for reintubation within 48 hours following extuba- tion trials. ข้อมูลและการวิเคราะห์ทางสถิติ Patient demographics and Acute Physiology and Chronic Health Evaluation (APACHE II) score measured at the time of admission, duration of MV, size of endotracheal tube, or reasons for MV to the ICU were noted. The primary physicians were blinded to the study design and to the measurements obtained during the, although arterial blood gas values and routine measurements by respiratory therapist (ie, spontaneous tidal volume, spontaneous and total respiratory rate, peak airway, peak alveolar pressures, laboratory data, and vital signs) were avail- able to them. Results are expressed as the mean±SD. Descriptive analysis (frequencies for categorical data, mean, SD, and box plot for numerical variables) was performed according to 2 groups, successful and failed weaning. Categorical variables were compared using the χ 2 test or Fisher exact test when χ 2 was not appropriate. Differences between groups were assessed for statistical significance using the KruskalWallis test. P value of ≤ .05 was considered significant. All statistical analyses were performed using the SAS Software version 8.2. Results 40 patients in the ICU were included in the study. There were no significant differences between the treatment groups regard- ing age, sex, weight, APACHE II score at ICU admission, duration of MV, size of endotracheal tube, or reasons for MV to the ICU (p>0.05) (Tab. 1). There were no significant differences within and between in T-piece and CPAP groups according to pO 2 , pCO 2 , pH values at the beginning of the weaning, duration extubation and after 48 hours of the extubation (p>0.05) (Tab. 2)
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