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临床试验/CTRI/2024/05/067657
CTRI/2024/05/067657招募中1/2 期

Evaluation of fiberoptic bronchoscope, c mac videolaryngoscope(D blade) and kingvision videolaryngoscope (channelled blade) for awake tracheal intubation in patients with predicted difficult airway.

Government Institute of medical science1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年6月12日最近更新:

试验速览

阶段
1/2 期
状态
招募中
发起方
入组人数
75
试验地点
1
主要终点
To assess the time required for awake intubation using fiberoptic bronchoscope, C-MAC Videolaryngoscope and kingvision videolaryngoscope.

研究概览

简要总结

This study will involve  patients classified as American Society of Anesthesiologists (ASA) I-II at our hospital. Written informed consent will be obtained from all participants. The study will enroll patients with undergoing surgery under general anesthesia . The patients will be randomly assigned to three groups

Group 1 (n=25): awake tracheal intubation through fiberoptic bronchoscope.

Group 2 (n=25): awake tracheal intubation through D blade of cmac videolaryngoscope.

Group 3(n=25):Awake tracheal intubation through channelled kingvision videolaryngoscope.

Outcome measures-

1.The time required for awake intubation using fiberoptic bronchoscope, C-MAC Videolaryngoscope and kingvision videolaryngoscope will be noted. Intubation time in seconds was calculated from insertion of C-MAC videolaryngoscope,kingvision laryngoscope or fiberoptic bronchoscope(FOB) in the mouth till confirmation of ETT was done by capnography.

2.First attempt success rate-Number of patients which could be intubated in a single attempt was recorded in each group.

 3. Number of attempts needed for intubation- An intubation attempt was considered unsuccessful if the VL was removed from the oral cavity owing to coughing, gagging, or inability to view the vocal cords.Maximum of three attempts were allowed.

4.Laryngeal view -The laryngeal view was assessed by the percentage of glottic opening (POGO) scale./percentage of glottis opening scale.

 5.Ease of intubation.

6.Hemodynamic parameters, which include heart rate (HR), mean arterial blood pressure (MABP), and O2% saturation, will be recorded immediately pre-intubation as baseline reading and then at 1 and 5 min post-intubation.

7.Complications or side effects during intubation such as blood clots on the device due to dental or lip trauma and postoperative sore throat will be noted

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 65.00 Year(s)(—)
性别
All

入选标准

  • Inclusion criteria- 1 ASA grade I / II.
  • 2 Age between 18-65 years.
  • 3 Patient undergoing surgeries requiring general anaesthesia with intermittent positive pressure ventilation in adult paralyzed patients.
  • 4.Patients with anticipated difficult airway.

排除标准

  • ⮚ History of upper gastro-intestinal surgery.
  • bleeding or clotting abnormalities.
  • oesophageal trauma , oesophageal varices or evidence of upper gastro-intestinal bleed hiatus hernia, gastroesophageal reflux disease.
  • ⮚ Pregnancy.
  • ⮚ Patient having significant medical diseases in term of cardiac, respiratory, hepatic, ⮚ renal, etc.; cervical spine pathology ⮚ upper airway pathology; ⮚ Difficult front of neck access.
  • ⮚ Risk of regurgitation, and airway surgeries will be excluded from the study.

结局指标

主要结局

To assess the time required for awake intubation using fiberoptic bronchoscope, C-MAC Videolaryngoscope and kingvision videolaryngoscope.

时间窗: 0MINUTE,5 MINUTE,10MINUTE

次要结局

  • First attempt success rate-Number of patients which could be intubated in a single attempt with each of the study device will be recorded(0MINUTE,5MINUTE,10MINUTE)

研究者

发起方
Government Institute of medical science
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

ANUPRIYA SAXENA

Government Institute of Medical Science

研究点 (1)

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