Positive Communication and Clinical Performance in Anaesthetic Care.

NCT03375073 | Completed

• 1 other identifier: CESAR001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The emotional and cognitive impact of positive communication between caregivers remains uninvestigated. The investigators hypothesize that positive communication during medical transmission can increase clinical performance for managing a subsequent stressful unexpected adverse event.

Conditions

Positive Communication; Clinical Performance; Anaesthesiology; High Fidelity Simulation

Outcome Measures

Primary Outcomes (1)

• Clinical performance of the anaesthetic team

  Clinical performance in a simulated scenario of laryngospasm occurring in a 7 year old child under general anaesthesia. Clinical performance will be scored from 0 to 100 by two independent blinded assessors, using video records and a pre-established scenario-specific checklist. The primary endpoint will be the mean of the two assessments for each performance.

  Each anaesthetic team will be involved once in the scenario. The scenario will last about 6 min (transmission not included). Both assessment of clinical performance will be made within 20 weeks of each simulation session

Secondary Outcomes (2)

• Heart rate variability

  Before the scenario (during 5 min), during medical transmission (2 min), during the scenario before the laryngospasm (2 min), during the laryngospasm (4 min), during the debriefing (20 min), after the debriefing (5 min)

• Self-reported stress

  Before the scenario (at 5 min), after medical transmission (at 7 min), after the scenario (at 13 min), after debriefing (at 33 min)

Study Arms (2)

Positive communication

EXPERIMENTAL

Positive communication during medical transmission

Other: Positive communication during medical transmission

Non-optimized communication

NO INTERVENTION

Medical transmission with non-optimized communication.

Interventions

Positive communication during medical transmission OTHER

Use of positive communication for medical transmission to the anaesthetic team who takes over the patient.

Positive communication

Eligibility Criteria

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

You may qualify if:

• Anaesthetic teams composed with :
• resident in anaesthesiology and critical care AND
• anaesthetic nursing student in second year OR 1 anaesthetic nurse graduated less than 5 years ago
• Refusal to be videotaped
• No consent to participate
• Anaesthetic nurses working in a paediatric operating room.

Sponsors & Collaborators

• University Grenoble Alps: lead

Study Sites (1)

University Grenoble Alps

La Tronche, 38700, France

Location

Related Publications (1)

• Bertrand B, Evain JN, Piot J, Wolf R, Bertrand PM, Louys V, Terrisse H, Bosson JL, Albaladejo P, Picard J. Positive communication behaviour during handover and team-based clinical performance in critical situations: a simulation randomised controlled trial. Br J Anaesth. 2021 Apr;126(4):854-861. doi: 10.1016/j.bja.2020.12.011. Epub 2021 Jan 7.

  PMID: 33422288 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Anesthesiology and Intensive Care

Model Details: Randomized controlled trial, with a 1:1 allocation ratio

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: December 15, 2017
• Study Start: November 29, 2017
• Primary Completion: June 29, 2018
• Study Completion: September 29, 2018
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

FR (1)