跳至主要内容
临床试验/CTRI/2025/09/094428
CTRI/2025/09/094428尚未招募不适用

AN OBSERVATIONAL STUDY COMPARING FREMANTLE SCORE AND MODIFIED INTUBATION DIFFICULTY SCORE FOR EASE OF INTUBATION ON VIDEOLARYNGOSCOPY IN PEDIATRIC PATIENTS UNDERGOING SURGERIES UNDER GENERAL ANESTHESIA WITH ENDOTRACHEAL INTUBATION

BHARATI HOSPITAL AND RESEARCH CENTRE1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2025年9月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
182
试验地点
1
主要终点
To compare Fremantle score and modified intubation difficulty score for ease intubation on videolaryngoscopy in pediatric patients undergoing surgeries under general anesthesia with endotracheal intubation

研究概览

简要总结

After obtaining approval from institutional ethical committee and informed consent from the parents ,total number of 182 patients between the age group of 2-8 years undergoing elective surgeries under general anesthesia  will be included in the study • Risk identification with detailed preoperative evaluation will be done. They will be explained the general procedure of intubation. All the patients will be kept nil by mouth for 6 hours prior to surgery. On the day of surgery patients will be brought to the operation theatre. A peripheral IV catheter was placed before entering the operating room with patients. Before induction of anaesthesia, 3 lead ECG, baseline blood pressure, mean arterial blood pressure, saturation, heart rate will be recorded in each patient. Standard monitoring of pulse rate, systolic, diastolic and mean blood pressure and saturation will be done intra-operatively. Standard protocol of General Anaesthesia will be followed in all patients as follows: 1)Pre anaesthesia check-up as per the proforma I 2) Pre-op counseling 3) General Anaesthesia induction- Premedication – Injection Glycopyrrolate 0.004mg/kg i.v, Injection Midazolam 0.05mg/kg iv. Followed by, Injection Ketamine 2mg/kg iv, Injection Fentanyl 2mcg/kg i.v and Injection Propofol 2mg/kg iv. The drugs will be diluted and given slowly. Patient will be given – Inj. ATRACURIUM 0.5mg/kg , IPPV and then video-laryngoscopy will be performed. During video-laryngoscopy, Modified Intubation difficulty Score (mIDS) and Fremantle score will be noted. Also Time taken for intubation (in seconds) will a be noted. It is the time from introduction of the laryngoscope blade into the mouth to the visual appearance of capnography trace on the monitor.  Patient will be then intubated with portex(uncuffed/microcuffed/cuffed)  ETT according to calculated size. The intubation will be done by trained anaesthesiologists (after 1 year of training). Maintainance – Inj. ATRACURIUM 0.5mg/kg + IPPV close circuit + Sevoflurane. After conclusion of surgery, Patient will be reversed by Neostigmine 0.05mg/kg + Glycopyrrolate0.01mg/kg and extubation of endotracheal tube from tracheal will be performed after thorough oropharyngeal suctioning and after confirmation of spontaneous adequate regular respiration.

研究设计

研究类型
Observational

入排标准

年龄范围
2.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Patients aged between 2-8 years of age with American Society of Anaesthesiologists(ASA) Grade I & II of both sexes.
  • Patients undergoing elective surgeries under general anaesthesia.

排除标准

  • Patients having anticipated difficult airway will be excludued like, 1)Patient having multiple facial trauma, 2) Patients having oral or nasal cavity masses, 3) Patients having midline neck swellings, 4) Patients having tracheal pathology like tracheal stenosis, tracheo esophageal fistula, tracheomalacia etc, 5) if intra operative position of patient is prone, 6) parents refusal to participate in the study.

结局指标

主要结局

To compare Fremantle score and modified intubation difficulty score for ease intubation on videolaryngoscopy in pediatric patients undergoing surgeries under general anesthesia with endotracheal intubation

时间窗: 3-5 minutes from the time of videolaryngoscopy. .

次要结局

  • To compare success rate of intubation in first attempt with Fremantle score & modified intubation difficulty score.(3-5 minutes from the time of videolaryngoscopy)

研究者

发起方
BHARATI HOSPITAL AND RESEARCH CENTRE
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr. Visakh K Mohan

BHARATI VIDYAPEETH DEEMED TO BE UNIVERSITY MEDICAL COLLEGE

研究点 (1)

Loading locations...

相似试验