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临床试验/NCT07510542
NCT07510542招募中不适用

Comparison of the Efficacy of Non-channelled Video Laryngoscopy Versus Direct Laryngoscopy in Terms of Stress Response and Intubation Time: a Single-blinded Randomized Controlled Trial

Sindh Institute of Urology and Transplantation1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2026年3月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
124
试验地点
1
主要终点
Heart rate

研究概览

简要总结

Impact of using video laryngoscopy versus direct laryngoscopy technique in terms of improved hemodynamics post intubation and time taken for intubation.

详细描述

The research will be conducted as a single-blind study involving patients undergoing elective surgical processes that necessitate endotracheal intubation. Informed consent will be obtained from all patients. Participants will be randomly assigned through a computer-generated sequence number to either the DL (direct laryngoscopy) group or the VL (video laryngoscopy) group. Monitoring will include vital signs and measurements such as non-invasive blood pressure (NIBP), electrocardiography (ECG), and pulse oximetry (SpO2). Prior to the induction of anesthesia, each patient will undergo assessments including oxygen saturation, blood pressure, echocardiography, systolic, diastolic, and mean blood pressure, heart rate, and oxygen saturation. In addition to the stated observations, the same assessments will be done after one minute of induction, after three minutes of bag-mask ventilation, and one, three, and five minutes after intubation. The time taken to perform endotracheal intubation will also be noted for both direct laryngoscopy and video laryngoscopy. All subjects will be premedicated with Inj. midazolam 0.03 mg/kg. For all patients, the same general anesthesia protocol will be applied, with patients preoxygenated with 100% oxygen for three minutes prior to induction, which will be done with Inj. Nalbuphine 0.15 mg/kg and Inj. propofol 2 mg/kg I.V. After evaluating bag-mask ventilation, Inj. Atracurium at 0.6 mg/kg I.V. will be administered, and isoflurane at 1.2% (1 MAC) will be initiated. After three minutes of bag-mask ventilation, intubation will be performed using either direct laryngoscopy or a non-channelled video laryngoscope, and the time taken for laryngoscopy and intubation will be recorded. Based on the groups, one of the two methods will be utilized to insert the appropriate endotracheal tube. In Group A, endotracheal intubation will be conducted using an indirect non-channelled VL. In Group B, endotracheal intubation will be performed using DL. The placement of the tube will be verified through capnography and chest auscultation before it is secured in position.

Group A The intubation process will utilize the Besdata (BD-M7) Portable VL, which is an indirect laryngoscope without a channel. The investigator will use a curved rigid stylet that is pre-shaped to match the laryngoscope blade, allowing for intubation with either a size 3 or 4 blade. In this research, the time taken for intubation will be recorded using an external timer. This involves measuring the interval from when the blade is inserted into the patient's mouth to the detection of the first capnography wave, while simultaneously using the timer to monitor vital parameters.

Group B Endotracheal tube (ETT) insertion via DL with a blade size of either 3 or 4 in the patients; the same external timer will be used as for group A.

Laryngoscopy in both groups will be conducted by an anesthetist with a minimum of five years of experience in anesthesia practice, ensuring the provision of high-quality care across both groups.

Data Analysis: The data collected will be analyzed via the SPSS software package v.26.0. Numerical variables will be presented as means (standard deviations) for normally distributed variables and as medians (IQRs) for non-normally distributed variables. For categorical variables (as frequencies), and group comparisons between numerical and categorical variables will be performed via the unpaired t-tests and the chi-square tests, respectively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

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

  • ASA I & II
  • Age 18-60 years.
  • Preoperatively nonhypertensive and hemodynamically stable patients
  • Patients scheduled for elective procedures not involving airway surgeries
  • Patients with informed consent
  • Mallampati score I and II
  • Interincisor gap > 3 cms
  • BMI less than 30 kg/m²

排除标准

  • Patient refusal
  • ASA III, IV & V
  • Hemodynamically unstable patients
  • Patients with Hypertension and Ischemic Heart Disease (whether controlled or uncontrolled)
  • Airway abnormalities, including congenital airway malformations & maxillofacial abnormalities
  • Head, neck or any facial traumas or history of prior head, neck or airway surgeries
  • Emergency procedures
  • Pregnancy

研究组 & 干预措施

Video Laryngoscope (VL)

Experimental

The intubation process will utilize the Besdata (BD-M7) Portable Video Laryngoscope (VL), which is an indirect laryngoscope without a channel. We use a curved rigid stylet that is pre-shaped to match the laryngoscope blade, allowing for intubation with either a size 3 or 4 blade. In this research, the time taken for intubation will be recorded using an external timer. This involves measuring the interval from when the blade is inserted into the patient's mouth to the detection of the first capnography wave, while simultaneously using the timer to monitor vital parameters.

干预措施: Endotracheal Intubation through a Video Laryngoscope (VL) (Device)

Direct Laryngoscope (DL)

Active Comparator

Endotracheal tube (ETT) insertion via Direct Laryngoscope (DL) with a blade size of either 3 or 4 in the patients; the same external timer will be used as for group VL.

Laryngoscopy in both groups will be conducted by an anaesthetist with a minimum of five years of experience in anaesthesia practice, ensuring the provision of high-quality care across both groups.

干预措施: Endotracheal Intubation through a Direct Laryngoscope (DL) (Device)

结局指标

主要结局

Heart rate

时间窗: Perioperative

Heart rate will be monitored through a 3-lead ECG monitor

Systolic Blood Pressure

时间窗: Perioperative

Systolic Blood Pressure will be monitored via a non-invasive blood pressure monitor with an appropriate BP cuff attached to any arm of the patient.

Diastolic Blood Pressure

时间窗: Perioperative

Diastolic blood pressure will be monitored via a non-invasive blood pressure monitor with an appropriate BP cuff attached to any arm of the patient.

Mean Blood Pressure

时间窗: Perioperative

Mean blood pressure will be monitored via a non-invasive blood pressure monitor with an appropriate BP cuff attached to any arm of the patient.

次要结局

  • Duration of Laryngoscopy(Perioperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Syed Muhammad Abbas

Professor

Sindh Institute of Urology and Transplantation

研究点 (1)

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