Changes in Carotid Artery Corrected Flow Time following a simulated end-inspiratory occlusion maneuver as a predictor of hypotension after induction of general anaesthesia in elective surgeries - A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Baseline Carotid Flow Time, Baseline Corrected Carotid Flow time, Carotid flow time and corrected carotid flow time following end inspiratory occlusion maneuver, change in corrected carotid flow time following end inspiratory occlusion maneuver.
研究概览
简要总结
Hypotension after induction of general anaesthesia and intra-operative hypotension is common and may be associated with fatal outcomes such as end organ damage and myocardial ischemia. This study is a prospective observational study conducted in AIIMS Rishikesh and it aims to determine the utility of the change in common carotid artery corrected flow time following a simulated end inspiratory occlusion maneuver for prediction of hypotension after induction of general anaesthesia. The study will include patients aged 18-65 years of age undergoing elective surgeries under general anaesthesia. The outcome variables that will be recorded are baseline and post simulated inspiratory occlusion maneuver corrected carotid artery flow time and carotid peak systolic velocity using carotid ultrasonography and hemodynamic parameters such as Heart Rate, Blood Pressure and Oxygen saturation at different time points after endotracheal intubation. Statistical analysis will done using statistical software SPSS 25.0 and statistical significance will be set at p<0.05. Ethics Approval for the study was taken from Institutional Ethics Committee from AIIMS Rishikesh.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients Undergoing Elective Surgeries Patients adherent to routine fasting protocols before surgery.
排除标准
- •Patients with severe hypertension or SBP more than 160mmHg or hemodynamic instability.
- •Patients with baseline MAP less than 70mmHg or SBP less than 90mmHg.
- •Patients with history of Atherosclerosis, arrhythmia, symptomatic cardiac patients and major valvular heart disease.
- •Patients with Diabetes having autonomic neur.
- •Patients with severe pulmonary disease, or respiratory insufficiency or features of Cor Pulmonale.
- •Hypertensive patients on ACE inhibitors or Angiotensin receptor blockers before surgery.
- •Chronic Kidney Disease patients with AV fistula or on dialysis.
- •Patients on prolonged fasting.
- •Patients failing to comply with simulated end inspiraotry occlusion maneuver.
- •Patients in which getting clear and effective USG images and measurements are not possible.
- •Patients with significant carotid artery stenosis of more than 50 percent or other carotid abnormalities detected on preoperative imaging.
- •Patients with history of recent myocardial infarction or unstable angina.
- •Patients with a history of significant bleeding disorders or active bleeding at the time of surgery.
- •Patient with history of severe neurological disorders affecting autonomic function such as parkinsons disease or multiple system atrophy.
- •Patients with history of severe anaemia with hemoglobin less than 8, or requiring ongoing blood tranfusions.
- •Patients with history of severe liver disease or dysfunction.
- •Patients with history of recent major surgery or trauma within the last month.
- •Patients with history of severe cognitive impair psychiatric disorders that may affect their ability to participate in the study.
- •Patients with history of significant vasculitis or vascular abnormalities affecting carotid arteries.
- •Patients with known pregnancy or breastfeeding at the time of study.
结局指标
主要结局
Baseline Carotid Flow Time, Baseline Corrected Carotid Flow time, Carotid flow time and corrected carotid flow time following end inspiratory occlusion maneuver, change in corrected carotid flow time following end inspiratory occlusion maneuver.
时间窗: T0 - Baseline | Ts - Following End inspiratory occlusion maneuver | T1 - 3 minutes after endotracheal Intubation | T2 - 5 minutes after endotracheal intubation | T3 - 7 minutes after endotracheal intubation | T4 - 9 minutes after endotracheal intubation.
NIBP measurements of SBP, DBP and MAP at different time points after endotracheal intubation.
时间窗: T0 - Baseline | Ts - Following End inspiratory occlusion maneuver | T1 - 3 minutes after endotracheal Intubation | T2 - 5 minutes after endotracheal intubation | T3 - 7 minutes after endotracheal intubation | T4 - 9 minutes after endotracheal intubation.
次要结局
- Carotid Peak systolic velocity- Baseline and Following End inspiratory occlusion maneuver, change in carotid peak systolic velocity following end inspiratory occlusion maneuver.(T0 - Baseline)
- Hemodynamic parameters such as Heart Rate , SBP, DBP, MAP and SPO2 baseline and following end inspiratory occlusion maneuver, change in hemodynamic parameters following end inspiratory occlusion maneuver.(T0 - Baseline)
研究者
Dr Bhavna Gupta
All Inida Institute of Medical Sciences Rishikesh