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临床试验/NCT07506655
NCT07506655Enrolling By Invitation不适用

Comparison of Hemodynamic Stability and Intubation Timings and Cormack-Lehane Grading in Ramp Position Versus Sniffing Position

Shaheed Mohtarma Benazir Bhutto Institue of Trauma1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2026年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
2
试验地点
1
主要终点
First-Attempt Intubation Success Rate

研究概览

简要总结

The goal of this clinical trial is to find out whether the ramp position or sniffing position is better for endo tracheal intubation which provides better hemodynamic stability and short intubation time and good laryngoscopic view in regards of cormack lehane grading.

详细描述

This randomized controlled trial will be conducted at the Shaheed Mohtarma Benazir Bhutto Institute of Trauma after obtaining approval from the College of Physicians and Surgeons of Pakistan (CPSP) and the Ethical Review Committee. The study will also be registered on ClinicalTrials.gov prior to participant enrollment.

Participants will be allocated into two groups using computer-generated randomization. Group A will undergo tracheal intubation in the sniffing position using a fixed pillow height of 4 cm, while Group B will be positioned in the ramp position using a customized pillow height (4-8 cm) adjusted to achieve alignment of the external auditory meatus with the sternal notch. Allocation will be performed by the primary investigator prior to surgery.

All patients will receive a standardized anesthesia protocol with continuous ASA monitoring. Induction of anesthesia will be achieved using propofol (2 mg/kg) and nalbuphine (0.15 mg/kg), followed by atracurium (0.5 mg/kg) after confirmation of adequate mask ventilation. Controlled positive pressure ventilation will be maintained for three minutes before direct laryngoscopy using a Macintosh laryngoscope.

Laryngoscopy will be performed by the primary investigator, while a second anesthetist, blinded to the study objectives where feasible, will record procedural timings and hemodynamic parameters. Any adjuncts or optimization maneuvers used during intubation will be documented. Hemodynamic variables will be monitored at predefined intervals following intubation.

The study will be conducted as an open-label trial. All patient data will be handled confidentially, and anonymization will be ensured during data collection, analysis, and reporting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 60 years
  • ASA physical status I or II
  • Mallampati class I or II
  • Patients scheduled for elective surgery
  • BMI between 25 and 30
  • Either gender

排除标准

  • ASA physical status III or IV
  • Predicted difficult intubation (Mallampati class III or IV)
  • Maxillofacial trauma, tumors, or obvious malformations of the neck or face
  • Pregnancy
  • Unstable cervical spine

研究组 & 干预措施

Group B - Customized Pillow

Experimental

Participants receive a customized pillow height of 4-8 cm to align the external auditory meatus and sternal notch.

干预措施: Group B - Customized Pillow (Device)

Group A - Fixed Pillow

Experimental

Participants receive a fixed pillow height of 4 cm to align the head for laryngoscopy.

干预措施: Group A - Fixed Pillow (Device)

结局指标

主要结局

First-Attempt Intubation Success Rate

时间窗: During the procedure

Percentage of patients in whom successful intubation is achieved on the first attempt using the study device.

次要结局

  • Heart Rate(0, 3, and 5 minutes after intubation)
  • Intubation Time(Measured during the procedure (from laryngoscope insertion to confirmation via end-tidal CO₂))
  • Blood Pressure(0, 3, and 5 minutes after intubation)
  • Cormack-Lehane Grade(During laryngoscopy)

研究者

发起方
Shaheed Mohtarma Benazir Bhutto Institue of Trauma
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shafaq Memon

Principal Investigator

Shaheed Mohtarma Benazir Bhutto Institue of Trauma

研究点 (1)

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