Does the Presence of Observers Influence the Success of the Neonatal Endotracheal Intubation?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Evaluating the differences in the duration (seconds) to reach intubation of the mannequin between the two experimental conditions.
研究概览
简要总结
The Endotracheal intubation (ETI) of a neonate is a procedure that usually attracts a large number of observers. The fear of being judged by others could cause an increased level of stress, especially on the junior trainees. Little research has focused on the effect of the audience on the level of stress and therefore, on the success rate of complicated procedures in neonatal intensive care.
Hypothesis:Investigators hypothesize that time to successful intubation (in seconds) will be longer with the presence of observers.
详细描述
Objective: The aim of this study will be to provide objective evidence supporting that junior trainees are less successful at neonatal ETI when in the presence of a large audience. If this hypothesis is correct, this data will provide evidence to support the residents request for less people around during the procedure, which may increase the chance of a successful intubation.
After Investigators obtained written consent - the selected student-will be asked to wear a cardiac monitor and 5 minutes later after a period of rest, they will be called in the delivery room. Two minutes after their arrival they will be given a stylet and a 3.5 ET tube and will be asked to intubate orally a mannequin, after 30 seconds, the operator will be reminded of the time. After 45 seconds the attempts will be stopped.
Participants will be informed of their right to discontinue participation at any time. The trainee will be informed at the end of the experience about the aim of the study and will be asked to keep it confidential.
The trainees will be randomized in two groups that differentiate in the conditions under which they will start the intubation.
Condition A: Only the staff will be present with the operator Condition B: An audience of 5 people with at least 2 neonatologists will be present in case of junior resident or the responsible of stage in case of respiratory therapy students.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Junior residents during the first year of residency and respiratory therapy students who never had any experience with a real newborn intubation will participate to the studies. The mannequin used during the procedure is the same for all the students and is different from what they used during there training before starting the rotation in the NICU.
排除标准
- •Students with a history of beta blockers within in the past year and students with a history of antidepressant medication are excluded.
研究组 & 干预措施
Condition B
An audience of 5 people with at least 2 neonatologists will be present with the operator during the intubation of the mannequin.
干预措施: 5 observers (Other)
Condition A
Only the staff will be present with the operator during the intubation of the mannequin.
干预措施: 1 observer (Other)
结局指标
主要结局
Evaluating the differences in the duration (seconds) to reach intubation of the mannequin between the two experimental conditions.
时间窗: 24 hour
The duration of each individual attempt will be recorded as the time in seconds from insertion of the laryngoscope into the mouth to its removal.
次要结局
- The number of wrong ET length position between the condition A and B(24 hour)
- Variability of the heart rate of the operator between the condition A and B.(24 hour)
研究者
Dr Brahim Bensouda
MD
Maisonneuve-Rosemont Hospital