Pilot study for estimation of prevalence of frailty in adult male patients in different age groups scheduled for elective surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Prevalence of frailty in adult male patients
研究概览
简要总结
Study Protocol as follows: - (a) Written and informed consent will be obtained from all the patients to be included in the study. Ethical committee clearance would be taken from the institutional ethical committee. (b) The clinical trial registration would be accomplished. Patients fulfilling the inclusion criteria and giving the written and informed consent will be explained about the procedure and Clinical Frailty Scale. (c) Pre-Anaesthetic checkup will be done on OPD basis. (d) Anaesthesia PGT1 will get the Clinical Frailty Scale Questionnaire filled by the patients on day prior to surgery during pre-anaesthesia visit. Anaesthesia PGT1 will remain same for all 200 patients and will be blinded to the readings of Anaesthesia PGT2, who will be responsible for measuring muscle thickness by USG. (e) Day prior to surgery, Anaesthesia PGT2 will record Ultrasonographic Measurements of Rectus Femoris, Vastus Intermedius and Triceps muscles. Anaesthesia PGT2 has done 100 such scans under consultant guidance. Anaesthesia PGT2 will be same for all the 200 patients and will be blinded to the Clinical Frailty Scale. This will be done to minimise observer bias. Using Bedside Ultrasound Machine, muscle thickness of each patient will be measured. For this, thickness of following 2 muscles will be measured by Anaesthesia PGT2: - (i) Rectus Femoris and Vastus intermedius4- Patient will be in supine position. After measuring and marking the mid-point between greater trochanter and superior margin of patella, USG probe will be placed on the anterior portion of thigh. Thickness of muscle will be measured by ultrasound callipers starting from subcutaneous tissue to femur and recorded. (ii) Triceps- patient will be supine position. Arm of the patient will be asked to be kept in flexion such that hand rests over the forehead. In such way, posterior portion of the arm will come in front. Now, using ultrasound callipers, thickness of triceps will be measured at the level of midline of arm. (f) Serum Albumin level will be recorded on day prior to surgery. (g) After collection of data, results will be analysed.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- Male
入选标准
- •(i) All patients of age more than or equal to 18 yrs coming for elective surgery and consenting to be in study (ii) ASA grade I – II.
排除标准
- •(i) Patients refusing to consent for the study (ii) Patient with cardio-respiratory problems (iii) Patients with Chronic Renal Disease, chronic liver disease, immunocompromised patients (iv) Patient with psychiatric disease (v) All patients having muscular dystrophy and/or muscle atrophy due to any structural or physiological problem (vi) ASA Grade III and above.
结局指标
主要结局
Prevalence of frailty in adult male patients
时间窗: before start of surgery
次要结局
- Relation of BMI, USG guided measurement of Muscle Thickness, Serum Albumin and Clinical Frailty Score(Before start of Surgery)
研究者
Dr Nikita D Chikate
INHS ASVINI
