Clinical trial NCT02726724: Does the Presence of Observers Influence the Success of the Neonatal Endotracheal Intubation?
Official title: Does the Presence of Observers Influence the Success of the Neonatal Endotracheal Intubation?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: Stress-Resident performance-Observers
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 51
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

The residents who performed intubation in condition A will do a repeat intubation 24 hours later using condition B and vice versa. The time and the local of the 2 procedures will be the same in both conditions.

Time to successful intubation will be compared between the two experimental conditions for each subject with paired t test. A p\<0.05 will be considered significant.

To estimate the required sample size, Investigators used the study O'Donnel and al who gave an approximate intubation time for trainees of 38 seconds with standard deviation of 20 seconds (14). Using an alpha threshold of 0.05 and power of 80 %, a sample size of 51 subjects is required to detect 8 second difference time between the two different groups. Eight seconds represents a 25 % change in time to intubate and is clinically significant for a newborn.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Students with a history of beta blockers within in the past year and students with a history of antidepressant medication are excluded.

Primary outcomes:
measure: Evaluating the differences in the duration (seconds) to reach intubation of the mannequin between the two experimental conditions.
timeFrame: 24 hour
Secondary outcomes:
measure: Variability of the heart rate of the operator between the condition A and B.
timeFrame: 24 hour
measure: The number of wrong ET length position between the condition A and B
timeFrame: 24 hour
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Hopital Maisonneuve Rosemont
state: Quebec
Study officials:
affiliation: Maisonneuve-Rosemont Hospital
name: Brahim BB Bensouda, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bensouda B, Mandel R, Mejri A, Lachapelle J, St-Hilaire M, Ali N. Effect of an audience on trainee stress and performance during simulated neonatal intubation: a randomized crossover trial. BMC Med Educ. 2018 Oct 3;18(1):230. doi: 10.1186/s12909-018-1338-4.