Impact of Stress on Performance of Neonatal Endotracheal Intubation

NCT02758704 | Completed

• 1 other identifier: 4143
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

Brief Summary

This study will be a randomized controlled trial designed to analyse the impact of stress on the success rate of a simulated neonatal endotracheal intubation. To do this, pediatric residents will be enrolled and randomized to either a high-stress (HS) or low-stress (LS) environment where they will be asked to perform a standard neonatal intubation procedure. Subjects will then cross-over to the second scenario within a short window (1-2 weeks). Outcome measures include: endotracheal intubation success rate and assessment of the procedure performance by video-review using a standardized checklist rated by two independent reviewers. Stress level will be measured using salivary cortisol, heart rate and a standardized anxiety questionnaire.

Conditions

Neonatal Intubation Performance

Keywords

Intubation; Neonatal; Teaching; Stress; Simulation

Outcome Measures

Primary Outcomes (2)

• Success rate of endotracheal intubation procedure

  Successful intubation will be defined as correct placement of the endotracheal tube just below the level of the vocal cords and will be verified by one of the investigators at the end of the procedure. Each attempt will be limited to 30 sec, as per Neonatal Resuscitation Program guidelines. An esophageal intubation will be defined as the absence of chest rise upon completion of the procedure.

  5 minutes

• Intubation skill performance

  Endotracheal intubation procedures will be videotaped and performance will be assessed by two external reviewers using an ETI checklist (in the process of validation).

  within 24 months

Secondary Outcomes (5)

• Rate of esophageal intubation

  5 minutes

• Stress level - Cortisol Measurement

  within 24 months

• Stress level - Heart Rate

  within 24 months

• Stress level - STAI Questionnaire

  within 24 months

• Duration of intubation

  5 minutes

Study Arms (2)

High-Stress (HS)

EXPERIMENTAL

In the HS environment, the resident will be exposed to various stressors. There will be the presence of audio alarms as well as the presence of a senior physician who will be supervising the performance of the resident. In addition, the mannequin will be slightly unstable which will be reflected in its oxygen saturation dropping throughout the first 30 seconds the procedure.

Other: High stress; Other: Endotracheal intubation on mannequin

Low-Stress (LS)

ACTIVE COMPARATOR

In the LS environment, there will be absence of audio (alarms), physical (third-party supervisor, nurse and respiratory therapist) and situational (unstable infant) stressors.

Other: Low stress; Other: Endotracheal intubation on mannequin

Interventions

High stress OTHER

Generation of a stressful environment during a neonatal intubation procedure.

High-Stress (HS)

Low stress OTHER

Absence of stressful stimuli during neonatal intubation procedure

Low-Stress (LS)

Endotracheal intubation on mannequin OTHER

Endotracheal intubation will take place at the simulation centre on a mannequin.

High-Stress (HS); Low-Stress (LS)

Eligibility Criteria

• Age: Up to 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All residents enrolled in the pediatric residency program and subspecialties of University of Montreal.

You may not qualify if:

• Residents who have a medical condition that can impact cortisol levels, such as pregnancy, will be excluded from the cortisol analysis.

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Alberta Children's Hospital: collaborator

Study Sites (2)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Sainte-Justine Hospital

Montreal, Quebec, H3T 1C4, Canada

Location

MeSH Terms

Interventions

RCF3 protein, Arabidopsis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist, Clinical assistant professor

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: May 2, 2016
• Study Start: October 1, 2015
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: October 7, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share

Locations

CA (2)