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临床试验/CTRI/2019/10/021727
CTRI/2019/10/021727已完成不适用

A Prospective study of airway assessment and airway management in patients with oral malignancy undergoing oncosurgery

Lokmanya Tilak Municipal Medical College and General Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年10月21日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
1.Preoperative evaluation of airway

研究概览

简要总结

After IEC Permission, patients scheduled for the oral surgery under general anaesthesia and satisfying all inclusion criteria will be included into the study. All patients will be explained about the study and a written valid informed consent for their willingness to participate in the study will be taken.  A standard OT protocol for routine pre anaesthetic checkup will be followed.   Preoperative Airway Assessment related to oral malignancy  :  History: â— Duration of oral malignancy  â— Rapidity of growth of the oral malignancy:  It may indicate either hemorrhage or rapidly enlarging malignancy  â— H/o teeth trouble/loose tooth â— H/o difficulty in swallowing and breathing â— H/o bleeding from the swelling  â— Past H/o previous oral surgeries H/o difficult intubation in the past â— H/o Postoperative ventilator stay  â— H/o Radiation therapy   Examination:   A thorough airway examination will be done   â— Mouth opening : inter incisor gap â— Mallampatti classification â— Thyromental distance  â— Neck movement â— Ability to prognath Will be checked. In addition  â— Extent of oral swelling  Fixation of tongue to the floor of mouth â— Nasal patency â— Signs of airway distress- dyspnea, tachypnea, accessory muscles usage   EL GANZOURI RISK INDEX Variable  Findings Points Mouth opening >4 cm 0 < 4 cm 1 Thyromental distance >6.5 cm 0 6-6.5 cm 1 <6cm 2 Mallampati score I 0 II 1 III IV 2 Neck movement >90 0 80-90 1 <80 2 Ability to prognath yes 0 no 1 Body weight <90 kg 0 90-110 kg 1 >110 kg 2 History of difficult intubation None 0 questinable 1 definite 2  , All hematological and biochemical investigations will be done as per OT protocol. Chest X ray (PA view), ECG , and ABG will be noted in all patients . In addition, findings of CT scan or MRI of the head and neck will be note to delineate the exact location and extension.   Anesthesia Technique will be at the discretion of the consultant anesthesiologist. The technique followed in each case will be observed and noted.   Which technique is used for intubation of trachea :  They can be broadly divided into   Intubation after anesthetizing patient:  â— Which anesthetic agent was used: intravenous or inhalational  â— Which muscle relaxant was used for intubation. â— Specialized airway equipment kept ready and used will be noted. â— The commonly used equipment are intubating bougie, flexitip laryngoscope, video laryngoscopes such as King vision, Airtraq. Also supraglottic airway devices for emergency access to airway are kept ready.   Awake Intubation after anesthetizing airway  â— After direct laryngoscopy  â— Fiber optic laryngoscope with endotracheal tube mounted  on it, Type of tube used and size will be noted. â— The commonly used endotracheal tubes are        PVC endo-tracheal tube.        Flexo-metallic tube.   The position of tube placement will be confirmed by Capnography.  Airway Complications during tracheal intubation will be noted: The common complications include: â— Airway trauma such as injury to teeth, lips, tongue, tonsillar pillars and vocal cords  â— Partial or complete obstruction accompanied by varying degrees of hypoxemia and hypercapnia â— Desaturation  In addition, Hemodynamic instability if any will be noted   The standard intraoperative Monitoring done is ECG , pulse, blood pressure, oxygen Saturation, ETCO2, peak airway pressure, temperature, filling pressure , blood loss and urine output  At the end of surgery , the patient will be either reversed and extubated or shifted on ventilator as per the discretion of the attending anaesthesiologist .  If not extubated, reason of not extubation be noted .  Following parameters will be noted for extubation : i) Time of extubation ii) Method of extubation  iii) Use of any special gadget for extubation iv) Complication if any

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Age 18-65 years Both genders Patients with Oral Malignancy undergoing Oncosurgery.

排除标准

  • Unwilling to give consent.

结局指标

主要结局

1.Preoperative evaluation of airway

时间窗: During pre-op evaluation | During induction | During intubation

2.To determine factors associated with difficult intubation.

时间窗: During pre-op evaluation | During induction | During intubation

3.To study the predictive value of El Ganzouri risk index for determination of difficult intubation.

时间窗: During pre-op evaluation | During induction | During intubation

4.To study methods of induction of anesthesia and securing of airway

时间窗: During pre-op evaluation | During induction | During intubation

次要结局

  • 1.To study the Extubation method used(2.To study Airway related complications)

研究者

研究点 (1)

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