Comparison between Adaptive Support Ventilation and Traditional modes of mechanical ventilation SIMV combined with PSV in patients requiring postoperative elective ventilation after major abdominal surgeries a randomized controlled study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- To measure and compare the duration of mechanical ventilation in patients undergoing elective abdominal surgeries on adaptive supportive ventilation and conventional modes of ventilation ie SIMV Mode
研究概览
简要总结
After the completion of surgery, all enrolled patients will be transferred to the ICU with tracheal intubation, where they will be managed according to a standardized protocol. In both the study groups version of Hamilton C-3 (Hamilton Medical AG, Bonaduz, Switzerland) will be used. All enrolled patients will be electively ventilated as per standard sedation protocol using midazolam and fentanyl (Maintaining a RAAS Score between -2 and -3) using either ASV or conventional PSV and SIMV mode of ventilation as per randomisation.
Based on ABG analysis, if PH ranges between 7.35-7.45, P/F ratio > 150 and FiO2 < 40% and sedation will be stopped and the patient will be evaluated for potential weaning.
Good tolerance criteria and clinical stability (As per ACCP/ACCCM) will be evaluated every hour in terms of hemodynamic stability, normal mental status, no signs of anxiety, no signs of somnolence, no signs of dyspnea and with an acceptable ABG (pH 7.35- 7.45, P/F ratio > 150, FiO2 < 40%, respiratory rate < 35 breaths/minute).
Mechanical ventilation will be returned to the previous step if any of the following occurs:
Respiratory rate > 35 breaths/min Arterial oxygen saturation < 90%
Heart rate > 140 beats/min or a sustained increase or decrease in the heart rate of more than 20%
Systolic blood pressure > 200 mmHg or < 90 mmHg
Agitation Diaphoresis Arterial carbon dioxide tension (PaCO2) > 50 mmHg
Patients who successfully complete spontaneous breathing trial, with desirable ABG criteria shall be extubated and observed for the next 48 hours for any signs for failed extubation. Post extubation failure is defined as pH ≤ 7.35, an increase in arterial carbon dioxide > 15 mm Hg from value just prior to extubation, RR > 24 breaths/min and accessory muscle use.
Data collection methods including settings and periodicity: Data will be collected and entered in google forms and proforma sheets, from patients’ admission to ICU until their discharge/transfer from the ICU.
Statistical analysis: The data will be collected, assembled and analysed using Statistical Product and Service Solutions (SPSS version 20) software package for windows, Student Edition. The data will be collected over a period of one year. Results will be calculated after decoding the data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Age greater than 18 years All patients who have undergone abdominal surgeries of duration more than 3 hrs under GA and requiring post operative mechanical ventilation.
- •BMI less than 40 Kg per m2 ASA Grade I and II.
排除标准
- •Patients with obstructive or restrictive pulmonary disease Patients for re exploration surgeries Patient with Ejection fraction less than 30 percent Patient with gross electrolyte disturbance Patient with severe bleeding episode during surgery.
结局指标
主要结局
To measure and compare the duration of mechanical ventilation in patients undergoing elective abdominal surgeries on adaptive supportive ventilation and conventional modes of ventilation ie SIMV Mode
时间窗: 1st Point: Intubation in OT | 2nd Point: End of Surgery which will indicate total duration of Surgery as end point in OT | 3nd Point: Transfer in ICU. | 4th Point: Removal of ET Tube ie Weaning. Duration of ventilation will be difference between admission time in ICU and extubation time ie known as weaning time from the entry into ICU
次要结局
- To measure the rate of extubation failure(To measure the duration of ICU stay)
研究者
Dr Aman Kumar
Aiims Patna