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临床试验/CTRI/2025/07/091220
CTRI/2025/07/091220尚未招募不适用

Evaluation of ultrasound-guided airway parameters and their association with ease of intubation in patients with cervical spine pathologies undergoing intubation under general anesthesia: A prospective observational study

All India Institute of Medical Sciences Rishikesh1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
107
试验地点
1
主要终点
To determine incidence of difficult laryngoscopy and difficult intubation in patients predicted with difficult airway via ultrasonography

研究概览

简要总结

All the patients satisfying inclusion criteria will be evaluated at least one day prior to surgery

All of the patients will be kept nil per oral for solids for 8hrs and clear fluids upto 2 hrs prior to surgery. No sedative premedication will be administered in any of the patient.

Demographic and preoperative data such as age , sex , weight , BMI , Diagnosis of the patient, neurological status will be recorded along with ASA grade

In the preoperative ward the USG guided airway parameters will be assessed utilizing curvilinear and linear probe. Patients will be positioned in a supine position with head in neutral position, the mouth closed and the tongue on the floor of the mouth without any movement. Different parameters will be noted. Neck extension will not be done in any patient for USG guided airway assessment.

After shifting the patient to operation theatre , patient will be placed in supine position and ASA standard monitors (noninvasive blood pressure (NIBP) , Electrocardiography (ECG) , Pulse oximeter (Spo2) will be attached.

Peripheral IV cannulation will be done and infusion of Ringer Lactate will be started.

Anaesthesia in all the cases will be induced using Injection(Inj) Fentanyl 2mcg/kg, Inj Propofol 2 mg/kg and Vecuronium 0.1 mg/kg.Check ventilation will be done.Manual inline stabilization will be applied in all the cases.

Laryngocopy will be conducted by an experienced anesthesiologist with >3years of experience maintaining manual inline stabilization utilizing standard laryngoscope and Cormack Lehane grading will be recorded. Alternately Video laryngoscope maybe used and POGO score recorded.

Maintenance of anaesthesia will be done using 50 % oxygen in air , Sevoflurane (0.8 - 1.0 MAC) with intermittent boluses of inj.Vecuronium 0.02 mg/kg.

Central venous catheter of 7 FG will be placed in right internal jugular vein or subclavian vein and right radial artery will be cannulated for invasive blood pressure monitoring as per need of surgery.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • ASA grade I, II, III, Diagnosed with cervical spine pathology (Rheumatoid arthritis, Cervical spondylosis, Ankylosing spondylitis, Prolapsed intervertebral disc, Craniovertebral junction anomalies, Infective pathology), Scheduled for elective surgery requiring airway management.

排除标准

  • ASA grade IV, V,Patients with head and neck malignancies affecting airway anatomy and mouth opening,Patients with major neurological sequlae (weakness, paresis, bladder & bowel disturbances),Patients with prior tracheostomy or airway surgery, Patients with anticipated difficult intubation on physical airway assessment, Obesity with BMI greater than 30kg/m2.

结局指标

主要结局

To determine incidence of difficult laryngoscopy and difficult intubation in patients predicted with difficult airway via ultrasonography

时间窗: Baseline

次要结局

  • To determine the predictive ability of clinical airway predictors(To compare the efficacy of clinical & sonographic airway parameters for predicting difficult airway)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Saumya Adhikari

ALL INDIA INSTITUTE OF MEDICAL SCIENCES(AIIMS) Rishikesh

研究点 (1)

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