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CompletedNCT03375073ComPerfUpdated Apr 18, 2019

Positive Communication and Clinical Performance in Anaesthetic Care.

An interventional study of Positive communication during medical transmission in Positive Communication, Clinical Performance and Anaesthesiology, sponsored by University Grenoble Alps. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-18.

Sponsored by University Grenoble Alps · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Positive Communication
  • Clinical Performance
  • Anaesthesiology
  • High Fidelity Simulation

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03

In context

Communication

719 studies on the registry are indexed under Communication; 159 are open to participants now.

This study's enrollment of 32 is below the median of 144 across 571 interventional studies indexed under Communication.

Browse Communication studies →

Lead sponsor

University Grenoble Alps is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Positive communication

    Positive communication during medical transmission

    Other: Positive communication during medical transmission

  • No intervention
    Non-optimized communication

    Medical transmission with non-optimized communication.

Interventions

  • OtherPositive communication during medical transmission

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

06

What researchers measure

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.

    Time frame: 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

  1. Heart rate variability

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

    Time frame: 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)

  2. Self-reported stress

    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%).

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

07

Study locations

1 site
  • University Grenoble Alps
    La Tronche, 38700, France
08

References and documents

Publications

  • 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. PubMed 33422288 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2017 to primary completion in Jun 2018, 7 months.

Of 390 non-industry interventional studies with no phase under Communication, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's 7 months is below that.

Counting every sponsor, half of 394 studies reached it within 18 months; a quarter within 6 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 22, 2017
First posted
Dec 15, 2017
StartActual
Nov 29, 2017
Primary completionActual
Jun 29, 2018
CompletionActual
Sep 29, 2018
Last update
Apr 18, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03375073
Lead sponsor
University Grenoble Alps
Responsible party
Pierre ALBALADEJO (Clinical Professor, Anesthesiology and Intensive Care, University Grenoble Alps) — Principal investigator
First posted
Dec 15, 2017
Start date
Nov 29, 2017
Primary completion
Jun 29, 2018
Completion
Sep 29, 2018
Last update
Apr 18, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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