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临床试验/CTRI/2018/03/012378
CTRI/2018/03/012378已完成不适用

A Prospective Randomized Study To Compare King Vision Video Laryngoscope And McGrath Video Laryngoscope In Adults Patients Undergoing Laparoscopic Cholecystectomy

Department Of Anaesthesiology1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年3月22日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
To compare the laryngoscopy & intubation time using the two devices.

研究概览

简要总结

This study entitled “A Prospective Randomized Study To Compare  King Vision Video Laryngoscope And McGrathVideo Laryngoscope In Adult Patients Undergoing Laparoscopic Cholecystectomy†wasperformed to compare the two different laryngoscopes.

60 ASA physical status I and IIof either sex (20-60 yrs. of age) undergoing general anaesthesia for electivelaparoscopic cholecystectomy surgery were included in the study. Patients withall MP class were included. After obtaining approval from Board of studiesDepartment of Anaesthesiology and Institutional ethical committee, patientswere randomly divided into two groups. Patients of KV Group [N=30] wereintubated using King Vision video laryngoscope and patients of MV Group [N=30]were intubated using McGrath video laryngoscope. Blinding of the attendinglaryngoscopists was not possible as the two laryngoscopes were markedlydifferent.

All patients in the both groupswere monitored using  all standardmonitors; female patients were intubated with 7.0 mm PVC ETT (endotrachealtube) whereas male patients were intubated with 8.0 mm PVC ETT

The King Vision VLs and McGrathVLs were compared with each other with respect tolaryngoscopy and intubation time, changes in heart rate and blood pressureafter intubation at different interval of time, number of attempts forsuccessful intubation, number of adjustment maneuvers, ease of trachealintubation and post extubation complications.

Of all the patients who wereintubated; 93.33% of the patients were intubated in single attempt with KingVision VLs as compared to 70% with McGrath VLs. However second attemptsintubation rate was 100% both in King Vision VLs and McGrath VLs. Among the twoinstruments none had taken more than two attempts for successfulintubation.

The King Vision VLs did requiredless adjustment maneuvers as compared to McGrath VLs. 10% and 46.66% patientsrequired more than two adjustment maneuvers in King Vision VLs and McGrath VLsrespectively.

The incidence of ease ofintubation grade 1 with King Vision VLs and McGrath VLs was 90% and 63.33%respectively. However 10% and 36.66% patients had grade II ease of intubationin King Vision VLs and McGrath VLs respectively. Among the two instrument nonehad shown a failed intubation.

The mean intubation time was12.56 second and 22.2 seconds in King Vision VLs and McGrath VLs respectively.McGrath VLs required more time than King Vision VLs to intubate the patients.

In both groups; there was asignificant rise in heart rate from pre induction value to immediate postintubation, 3 and 5 minute of post intubation but came down near to preinduction value within 10 minutes of intubation. In inter group comparisonbetween two groups at a time, variation in heart rate did show statisticallysignificant rise with McGrath VLs as compared to King Vision VLs during 3 minpost intubation.

Both groups showed significantchange in MABP at post intubation period, although comparatively lesser in KVgroup. Rise in MABP was statistically significant at immediate post intubationand 3 minute post intubation time.

The incidence of complicationslike sore throat, blood staining on ETT and hoarseness after extubation wasless in KV group as compared to MV group.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

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

入选标准

  • ASA Grade I and II Weight between 40-70 Kg Patients planned for Elective Laparoscopic Cholecystectomy.

排除标准

  • Previous history of multiple/ failed intubation.
  • Head and neck surgery.
  • Valvular heart disease.
  • CAD / Uncontrolled hypertension.
  • Presence of raised intracranial pressure.
  • Cervical spine injury.
  • Predicted difficult laryngoscopy except for all class of MP Grades Any pathology of the oral cavity that will obstruct the insertion of device.
  • Mouth opening <2.5cm.
  • Potentially full stomach patients (trauma, morbid obesity, pregnancy, history of gastric regurgitation and heart burn) and at risk of esophageal reflux (hiatus hernia).

结局指标

主要结局

To compare the laryngoscopy &amp; intubation time using the two devices.

时间窗: Two years from start of study

To compare the glottic view using POGO (percentage of glottic opening) score.

时间窗: Two years from start of study

To compare the hemodynamic response i.e., heart rate and mean arterial B.P. after laryngoscopy and intubation.

时间窗: Two years from start of study

To compare the success of laryngoscopy &amp; intubation in all classes of Mallampati grading.

时间窗: Two years from start of study

次要结局

  • To grade the ease of tracheal intubation using these devices.(To compare the number of adjustment maneuvers required for successful intubation.)

研究者

发起方
Department Of Anaesthesiology
申办方类型
Government medical college

研究点 (1)

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