跳至主要内容
临床试验/CTRI/2025/03/083448
CTRI/2025/03/083448尚未招募不适用

Comparison of modified C-E (C-ARM) facemask holding technique with conventional C-E facemask holding technique in adult patients by novice practitioners – A Prospective Randomized Triple Blinded Crossover trial.

All India Institute of Medical Sciences Mangalagiri1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年4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
200
试验地点
1
主要终点
Peak airway pressure

研究概览

简要总结

  • Bag mask ventilation (BMV) has been used routinely for oxygenation and ventilation during induction of anaesthesia, in emergency departments, during transportation of patients by the paramedical staff and especially in cardiopulmonary resuscitation. During emergency situations, the primary care givers might be with less experience to provide the airway care, when anaesthesiologist is not available readily. That’s why all healthcare providers should master the art of BMV. After  general  anaesthesia  the  tone  of  the  oral  and  pharyngeal  muscle  tone   reduces  leading  to  collapse  of  the  tongue,  soft  palate  and  epiglottis. An  improperly  placed  fingers  especially  middle  and  ring,  over  the  submandibular  soft  tissue,  can  compress  the  upper  airway  and  may  lead  to  obstruction  in  anesthetized  and  unconscious  apnoeic  patients. To bypass the obstruction adjustable pressure level valve will be closed high, which further can lead to gastric insufflation. Therefore  we  suggest  C - ARM,  where  little  finger  is  placed  at  the  Angle  (A),  4th finger  over  the  Ramus  (R)  and  3rd finger  over  Mentum  (M)  of  the  mandible. This  will  eliminate  the  soft  tissue  compression  and  airway  obstruction  by  precisely  placing  the  fingers  over  the  mandible  and  chin  lift  provided  with  3rd finger.  It  is  also  easier  to  remember  C – ARM  acronym,  for  novice  practitioners.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

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

入选标准

  • Patients scheduled for elective surgery requiring general anaesthesia American Society of Anesthesiologist Physical Status (ASA PS) I & II.

排除标准

  • History of respiratory failure or significant pulmonary diseases Severe cardiovascular comorbidities Patients with difficult airway with facial anomalies Risk of regurgitation and aspiration Pregnant and psychiatry patients Mallampati grade 3 and 4 Edentulous Limited neck & temporomandibular joint mobility Large Beard Obstructive sleep apnea Body mass index more than 30kg/m2 Comet tail (air) on 1st gastric USG Leak more than or equal to 1ml/kg during mask holding.

结局指标

主要结局

Peak airway pressure

时间窗: Baseline | 5 seconds | 10 seconds | 15 seconds | 20 seconds | 25 seconds | 30 seconds | 35 seconds | 40 seconds | 45 seconds | 50 seconds | 55 seconds | 60 seconds. | for each technique.

Set tidal volume

时间窗: Baseline | 5 seconds | 10 seconds | 15 seconds | 20 seconds | 25 seconds | 30 seconds | 35 seconds | 40 seconds | 45 seconds | 50 seconds | 55 seconds | 60 seconds. | for each technique.

End tidal carbon dioxide

时间窗: Baseline | 5 seconds | 10 seconds | 15 seconds | 20 seconds | 25 seconds | 30 seconds | 35 seconds | 40 seconds | 45 seconds | 50 seconds | 55 seconds | 60 seconds. | for each technique.

Change in tidal volume (Delta vt)

时间窗: Baseline | 5 seconds | 10 seconds | 15 seconds | 20 seconds | 25 seconds | 30 seconds | 35 seconds | 40 seconds | 45 seconds | 50 seconds | 55 seconds | 60 seconds. | for each technique.

次要结局

  • comfortability of novice practitioner using 5 point likert scale(At the end of completion of both the techniques)
  • visible chest rise(Baseline)
  • Presence of air in the stomach using ultrasonography(Baseline)
  • Oxygen Saturation (Spo2)(Baseline)
  • Length between the mentum to angle of the mandible of both sides(Baseline)
  • Novice parameters (Age, Gender, Dominant hand, hand used, length between thumb tip to little finger tip on full expansion)(Baseline)

研究者

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

Dr. Anusha Reddy Jambula

All India institute of medical sciences, Mangalagiri

研究点 (1)

Loading locations...

相似试验