ComPerf: Positive Communication and Clinical Performance in Anaesthetic Care.

• Sponsor: University Grenoble Alps (Other)
• Overall Status: Completed
• CT.gov ID: NCT03375073
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Actual Duration (Months): 10
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Positive Communication; Clinical Performance; Anaesthesiology; High Fidelity Simulation	Other: Positive communication during medical transmission	N/A

Detailed Description

When caregivers deal with acute stressful adverse events, cognitive overload and negative emotions can impair cognitive abilities and decrease clinical performance. The beneficial effect of positive communication on patients' emotions has widely been studied. However, the emotional and cognitive impact of positive communication between caregivers remains uninvestigated. The primary purpose of this trial is to study the impact of positive communication between anaesthetic teams during medical transmissions on clinical performance for managing a subsequent stressful unexpected adverse event. Secondary outcomes are to study the impact of positive communication on physiological (heart rate variability) and psychological (psychometric scales) levels of stress.

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled trial, with a 1:1 allocation ratioRandomized controlled trial, with a 1:1 allocation ratio
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Positive Communication Within Healthcare Team and Clinical Performance: a Prospective, Randomised and Controlled Simulation Trial.
• Actual Study Start Date: Nov 29, 2017
• Actual Primary Completion Date: Jun 29, 2018
• Actual Study Completion Date: Sep 29, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Positive communication Positive communication during medical transmission	Other: Positive communication during medical transmission; Use of positive communication for medical transmission to the anaesthetic team who takes over the patient.
No Intervention: Non-optimized communication Medical transmission with non-optimized communication.

Outcome Measures

Primary Outcome Measures

1. Clinical performance of the anaesthetic team [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]

   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.

Secondary Outcome Measures

1. 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)]

   Standard deviation of the average of RR intervals (SDNN in milliseconds) in participants

2. 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)]

   Stress level self reported by participants on visual analogical scale (VAS from 0 to 100); One end of the scale represents the maximum conceivable symptom strength (i. e., 100%), the other end no symptoms whatsoever (i. e., 0%).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion criteria

Anaesthetic teams composed with :

• 1 resident in anaesthesiology and critical care AND

• 1 anaesthetic nursing student in second year OR 1 anaesthetic nurse graduated less than 5 years ago

Non-inclusion criteria

• Refusal to be videotaped

• No consent to participate

• Anaesthetic nurses working in a paediatric operating room.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Grenoble Alps	La Tronche		France	38700

Sponsors and Collaborators

• University Grenoble Alps

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pierre ALBALADEJO, Clinical Professor, Anesthesiology and Intensive Care, University Grenoble Alps
• ClinicalTrials.gov Identifier: NCT03375073
• Other Study ID Numbers: CESAR001
• First Posted: Dec 15, 2017
• Last Update Posted: Apr 18, 2019
• Last Verified: Apr 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 18, 2019