To study the Proportion of Ultrasonically assessed Diaphragmatic weakness with the need for Postoperative Mechanical Ventilation in Geriatric Patients undergoing Abdominal Surgery under General anaesthesia:An Observational Study
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- ALL INDIA INSTITUE OF MEDICAL SCIENCES RISHIKESH
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To study the proportion of geriatric patients with diaphragmatic weakness, as assessed by ultrasound, requiring post-operative mechanical ventilation after abdominal surgery under general anaesthesia
概览
简要总结
The study protocol will be explained to the patients who will be found eligible for our study, based on inclusion criteria. A written consent will be obtained from those willing to participate in our study. In the preoperative room routine monitors [i.e., pulse oximeter, ECG and non-invasive blood pressure(NIBP)] will be attached and baseline vitals will be obtained. Mini Nutritional Assessment (MNA) score will be calculated in the preoperative period. Diaphragm function will be assessed using ultrasound.
Patients will be taken inside the operation theatre. All the routine monitors i.e., pulse-oximeter, ECG, and NIBP will be attached. An epidural catheter may be inserted based on anaesthetist’s discretion. Patient will be preoxygenated or denitrogenated to increase apnoea time followed by administration of injection (inj.) fentanyl 1-2μcg/kg i.v. Thereafter induction agents i.e., inj. propofol (1-2.5mg/kg) or etomidate (0.2-0.3mg/kg) i.v. will be given. For muscle relaxant inj. vecuronium 0.1 mg/kg i.v. will be used. Patient will be intubated and mechanically ventilated on volume control mode. Ventilatory settings will be as follows: - tidal volume (VT) 6-8ml/kg, respiratory frequency 12-14/min, PEEP 5 cm of H2O so as to maintain an EtCO2 of 30-35. Throughout the surgery the anaesthesia will be maintained using sevoflurane with 40% oxygen and intermittent injection of vecuronium. The Train of four (TOF)-ratio will be measured and dosage of vecuronium will be decided on its basis. The total requirement of muscle relaxant will be noted. Other than routine monitors we will attach bi-spectral index monitor on the forehead of the patient. We will maintain bi-spectral index between the ranges of 40-60.
After the surgery is over, diaphragm assessment (TFdi) will be repeated on both sides. Lung ultrasound score and ABG will be done for all patients to know the lung condition and need for mechanical ventilation. Patients will be extubated if they are meeting clinical criteria for extubation (i.e., regular respiration, stable vitals, follows commands, hand grip and head lift). Any patient not meeting the criteria for extubation within 1 hour of stopping muscle relaxant will be considered for elective mechanical ventilation as per the discretion of treating anaesthesiologist and surgeon.
All patients will be shifted to either post anaesthesia care unit (PACU) or intensive care unit or high dependency unit (depending upon availability of ventilator). 1 hour post operatively an ultrasonographic assessment of diaphragm, lungs and ABG will be performed to rule out pulmonary complications. Patient outcomes will also be assessed including delayed extubation, recovery, length of hospital stay, prolonged hospital stay, length of ICU stay and mortality for upto a period of 7 days.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 60.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •American society of Anaesthesia (ASA) class I to III, undergoing abdominal surgery under general anaesthesia.
排除标准
- •Refusal to consent for the procedure.
- •Patients with severely compromised lung function.
- •Patients with any known cardiac disease.
- •Patient already on mechanical ventilation.
- •Patients in shock.
- •Patient with altered mental status.
结局指标
主要结局
To study the proportion of geriatric patients with diaphragmatic weakness, as assessed by ultrasound, requiring post-operative mechanical ventilation after abdominal surgery under general anaesthesia
时间窗: immediately after surgery
次要结局
- To study and compare the change in the diaphragmatic function from the preoperative period to post-operative period in geriatric patients undergoing abdominal surgery under general anaesthesia(From before to after the surgery)
- To study the association of the ultrasound guided diaphragmatic function in the pre and postoperative period with the need for post- operative mechanical ventilation in geriatric patients undergoing abdominal surgery under general anaesthesia(Before the surgery)
- To study the association of the ultrasound guided diaphragmatic function in the preoperative and post-operative period with the development of post-operative pulmonary complications in immediate postoperative period as assessed by lung ultrasound(1 hour after the surgery)
- To study the association of the ultrasound guided diaphragmatic function in the preoperative period with the preoperative Mini Nutritional Assessment (MNA) score in geriatric patients undergoing abdominal surgery under general anaesthesia(immediately after surgery)
- To study the impact of epidural analgesia on change in diaphragmatic function from the preoperative period to post-operative period in geriatric patients undergoing abdominal surgery under general anaesthesia(Immediately after surgery)
- To study the association of pre-operative and post-operative diaphragmatic function with post-operative arterial blood gases(1 hour after surgery)
- To study the association of pre-operative and post-operative diaphragmatic function with incidence of delayed extubation(1 hour after surgery)
- To study the association of pre-operative and post-operative diaphragmatic function with patient outcome i.e. recovery, prolonged hospital stay, prolonged ICU stay, mortality(7 days)
研究者
Jyoti Suthar
All India Institute of Medical Sciences,Rishikesh