Does the Presence of Observers Influence the Success of the Neonatal Endotracheal Intubation?

NCT02726724 | Completed DMC

• 1 other identifier: Hopital Maisonneuve Rosemont
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress

Keywords

Stress-Resident performance-Observers

Outcome Measures

Primary Outcomes (1)

• Evaluating the differences in the duration (seconds) to reach intubation of the mannequin between the two experimental conditions.

  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.

  24 hour

Secondary Outcomes (2)

• Variability of the heart rate of the operator between the condition A and B.

  24 hour

• The number of wrong ET length position between the condition A and B

  24 hour

Study Arms (2)

Condition B

EXPERIMENTAL

An audience of 5 people with at least 2 neonatologists will be present with the operator during the intubation of the mannequin.

Other: 5 observers

Condition A

EXPERIMENTAL

Only the staff will be present with the operator during the intubation of the mannequin.

Other: 1 observer

Interventions

5 observers OTHER

Condition B

1 observer OTHER

Condition A

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead

Study Sites (1)

Hopital Maisonneuve Rosemont

Montreal, Quebec, H1T2M4, Canada

Location

Related Publications (1)

• 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.

  PMID: 30285715 DERIVED

Study Officials

• Brahim BB Bensouda, MD

  Maisonneuve-Rosemont Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: April 4, 2016
• Study Start: October 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 19, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)