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临床试验/CTRI/2025/11/096869
CTRI/2025/11/096869尚未招募不适用

A RANDOMISED STUDY TO COMPARE THE-FINGERS GRIP TECHNIQUE VS. CONVENTIONAL PEN-HOLDING GRIP TECHNIQUE TO HOLD AN ENDOTRACHEAL TUBE FOR OROTRACHEAL INTUBATION AT SMS MEDICAL COLLEGE JAIPUR.

Department of AnaesthesiaSawai Man Singh Medical College and Attached Hospital Jaipur1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年12月4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
300
试验地点
1
主要终点
1. The mean number of external assistance required during the procedure in the form of

研究概览

简要总结

Thia randamized comparative study aims to evaluate the effectiveness of the fingerts grip techniwue versus the conventional pen holding an endotracheal tube during orotracheal intubation.

participants undergoing elective surgeries ubder general anaesthesia will be randomly assinged to one of the two techniques. the study will compare intubation time ,ease of insertion,success rate and incidence of complications between the two groups. randomization will be computer generated allocation concealed using sealed opaque envelopes and outcome assessment will be performed by a blinded observer. the study will be conducted at SMS Medical College and attached hospitals ,Jaipur.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1 Patient giving written informed consent.
  • 2 Patient undergoing general anaesthesia.
  • 3 Adult patients aged between 18-60 years and both genders.
  • 5 Patients belonging to Mallampati Grade 1,2.

排除标准

  • Patients with cervical spine disease.
  • Patients with anticipated difficult airway.
  • Patients with upper airway abnormalities.
  • Patients with body mass index (BMI more than 35 kg/m?.
  • Patients with high risk of aspiration (hiatus hernia, gastroesophageal reflux dise.

结局指标

主要结局

1. The mean number of external assistance required during the procedure in the form of

时间窗: 1. The mean number of external assistance required during the procedure in the form of | BURP will be documented. | 2. Mean time taken for the completion of tracheal intubation by either of the two methods. | 3. Mean number of attempts taken. | 4. Mean change in Haemodynamic parameters | 5. Proportion of patients with complication | 6.At the time of intubation; | five minutes after intubation, | 10 minutes after intubation

BURP will be documented.

时间窗: 1. The mean number of external assistance required during the procedure in the form of | BURP will be documented. | 2. Mean time taken for the completion of tracheal intubation by either of the two methods. | 3. Mean number of attempts taken. | 4. Mean change in Haemodynamic parameters | 5. Proportion of patients with complication | 6.At the time of intubation; | five minutes after intubation, | 10 minutes after intubation

2. Mean time taken for the completion of tracheal intubation by either of the two methods.

时间窗: 1. The mean number of external assistance required during the procedure in the form of | BURP will be documented. | 2. Mean time taken for the completion of tracheal intubation by either of the two methods. | 3. Mean number of attempts taken. | 4. Mean change in Haemodynamic parameters | 5. Proportion of patients with complication | 6.At the time of intubation; | five minutes after intubation, | 10 minutes after intubation

3. Mean number of attempts taken.

时间窗: 1. The mean number of external assistance required during the procedure in the form of | BURP will be documented. | 2. Mean time taken for the completion of tracheal intubation by either of the two methods. | 3. Mean number of attempts taken. | 4. Mean change in Haemodynamic parameters | 5. Proportion of patients with complication | 6.At the time of intubation; | five minutes after intubation, | 10 minutes after intubation

4. Mean change in Haemodynamic parameters

时间窗: 1. The mean number of external assistance required during the procedure in the form of | BURP will be documented. | 2. Mean time taken for the completion of tracheal intubation by either of the two methods. | 3. Mean number of attempts taken. | 4. Mean change in Haemodynamic parameters | 5. Proportion of patients with complication | 6.At the time of intubation; | five minutes after intubation, | 10 minutes after intubation

5. Proportion of patients with complication

时间窗: 1. The mean number of external assistance required during the procedure in the form of | BURP will be documented. | 2. Mean time taken for the completion of tracheal intubation by either of the two methods. | 3. Mean number of attempts taken. | 4. Mean change in Haemodynamic parameters | 5. Proportion of patients with complication | 6.At the time of intubation; | five minutes after intubation, | 10 minutes after intubation

次要结局

  • 1 hemodynamics changes if any(2 complications if any)

研究者

发起方
Department of AnaesthesiaSawai Man Singh Medical College and Attached Hospital Jaipur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Ramesh Kumar

SMS Medical College Jaipur

研究点 (1)

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