跳至主要内容
临床试验/CTRI/2022/09/045372
CTRI/2022/09/045372尚未招募不适用

Comparison of Four Routinely Used Methods For Positioning of Oral Endotracheal Tube Tip in the Trachea – An Attempt to find a Simple, Easy and Accurate Method in Indian Adults

Sharda Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年9月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
试验地点
1
主要终点
1)To compare the percent positions of ETT tips positioned too low (3 cm above the carina) or too high (5 cm above the carina) using the four methods and to determine and compare the percentage of subjects in whom TT-tip comes in safe range of placement of 3-5 cm above the carina.

研究概览

简要总结

•A written informed consent for participation in the study will be obtained from each willing patient meeting the inclusion criteria after discussion of the study procedure and expected complications.

•Preoperative evaluation of the patient will be done as per standard protocol.

•Airway assessment will be done and Mallampati class, thyromental distance, mouth opening in the form of inter incisor gap and any restriction in flexion and extension movements of the neck will be noted.

•Patients will be kept nil per os overnight before surgery, as per usual practice.

•In the operation theatre, routine monitoring will be done. Patient will be made to lie supine comfortably in sniffing position.Patient will be taken under general anesthesia by routine protocol.

•Cuffed ETTs available routinely in India and the Sharda hospital, and supplied by M/s Romsons Group Pvt Ltd. shall be used for the study.

•Endotracheal tubes will be especially marked proximal to the proximal rim of the cuff at 0.5 cm distances and shall be used in all the groups to know the distance between the proximal rim of cuff to the vocal cords after the positioning of the ETT according to allotted method.

•After the hemodynamic variables have stabilized, 100% oxygen saturation ensured and adequate depth of anaesthesia achieved, the connector of the TT will be disconnected from the anesthetic circuit and fibreoptic endoscope introduced through the tube to measure the distances from within the trachea.

•All these measurements will be taken at the end of expiration and the lungs would be ventilated normally in between the measurements.

•Measurements would be taken at  separate depths,the carina and the tip of the tracheal tube. At each depth an adherent marker will be placed on the endoscope shaft

•Fiberscope shall be withdrawn and measurements from the tip of the fiberscope to each of the markers shall be noted and distance from the tip of the tracheal tube to the carina calculated using these values.

•Auscultation of chest shall be done in all patients after placement of the TT irrespective of the group to reinsure and confirm adequate and satisfactory ventilation

• End tidal capnography will also be routinely done as a part of routine essential monitoring.

•Anaesthesia will be maintained according to the standard guidelines practiced for all general anaesthesia cases.

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

  • 1.ASA physical status I-II.
  • 2.Normal airway with no anticipated difficulties in airway management.
  • 3.Cormack Lehane grading 1 and 2 on laryngoscopy.

排除标准

  • •Patients who do not give consent to participate in the trial.
  • •Any cause of difficulty in bag & mask ventilation, laryngoscopy and tracheal intubation including Mallampati class III and IV and mouth opening <3 cm.
  • •Surgical procedure involving oral cavity, pharynx, larynx and neck.
  • •Significant deformities of chin, pharynx and/or larynx.
  • •Any space occupying lesion in upper airway.
  • •Neck swelling or contracture.
  • •History of radiotherapy in head and neck region.
  • •Any cervical spine disorder or lesion of base of skull.
  • •Distorted tracheal anatomy.
  • •Need for intubation with flexometallic or preformed tubes.
  • •H/o URTI in last 15 days.
  • •Risk of pulmonary aspiration of gastric contents e.g., pregnant females, full stomach, upper GIT problems like gastro esophageal reflux disease.
  • •BMI ≥ 35 kg/m
  • •Causes of raised intracranial pressure.

结局指标

主要结局

1)To compare the percent positions of ETT tips positioned too low (3 cm above the carina) or too high (5 cm above the carina) using the four methods and to determine and compare the percentage of subjects in whom TT-tip comes in safe range of placement of 3-5 cm above the carina.

时间窗: immediately

2)To know and compare the distance of proximal rim of TT cuff from the vocal cords in the four methods and to compare the percentage of subjects in whom the position of TT cuff is in the safe range of 1.5-2.5 cm below vocal cords.

时间窗: immediately

次要结局

  • 1)To determine and compare the distance between upper incisors to TT tip (depth of insertion of tracheal tube).(2)To compare the upper incisors to carina distance.)

研究者

申办方类型
Private medical college

研究点 (1)

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