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临床试验/CTRI/2025/04/084069
CTRI/2025/04/084069尚未招募不适用

An observational Study for comparision between oxiport laryngoscope versus conventional laryngoscope for hemodynamic response during intubation in paediatric age group up to 3 years undergoing general anaesthesia.

Smt Bhikiben Kanjibhai Shah Medical Institute and Research Cen1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月14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
60
试验地点
1
主要终点
We will get to know and compare effects and efficacy of desaturation with two blades

研究概览

简要总结

Observational Study for comparision between oxiport laryngoscope versus conventional laryngoscope for hemodynamic response during intubation in paediatric age group up to 3 years undergoing general anaesthesia

AIM

To compare hemodynamic response during intubation between oxiport laryngoscope and

conventional laryngoscope in pediatric age group under going general anaesthesia.

OBJECTIVES

  1. To compare incidence of hypoxia during intubation

  2. To compare severity of hypoxia during intubation

  3. To compare no of intubation attempts

  4. Comparison of hemodynamic response

Site of Study  Department of Anaesthesiology, Dhiraj Hospital, S.B.K.S. Medical Institute and Research Centre, Piparia, Waghodia, Vadodara, Gujarat.

Study Design  Prospective Observational comparative Study

Study Duration  The study will be initiated after obtaining the permission from institutional ethics committee till the achievement of the sample size or by 18 months whichever is earlier.

研究设计

研究类型
Observational

入排标准

年龄范围
6.00 Month(s) 至 3.00 Year(s)(—)
性别
All

入选标准

  • Patients parents or gaurdians willing to sign the written informed consent.
  • Patients of either gender aged between 6 months to 3 years.
  • Patients belonging to ASA I and II.
  • No known history of allergy and hypersensitivity to study drug.

排除标准

  • Patients with history of prior hypoxic, patients with known upper respiratory tract infection or lower respiratory tract infection.
  • Patients with known allergy, sensitivity or any other form of reaction to study drug.
  • Patients with poor cardiovascular and respiratory reserve and a known case of congnital heart disease Patients with anaemia Hb less than 12 gm percentage.
  • Patients with ASA III or more.
  • Patient and or his or her legally acceptable representative not willing to provide their voluntary written informed consent for participation in the study.
  • Patients with oral pathologies like cleft lip and palate Patients undergoing nasal intubation.

结局指标

主要结局

We will get to know and compare effects and efficacy of desaturation with two blades

时间窗: We will get to know and compare effects and efficacy of desaturation and hemodynamic with two blades after Intubation | 0 min | 1 min | 2 min | 3 min | 5 min | 10 min | 15 min | 30 min | 45 min | 60 min | 90 min | 120 min

次要结局

  • hemodynamic changes like SPO2,SBP,DBP,PR(0min)

研究者

发起方
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Cen
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

DRKARNATI ESHWAR

Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre

研究点 (1)

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