Simulation Training and Teamwork Concerning Intubation on the Icu

The Influence of Simulation Education on Action of the Group Managing Patient's Airway on the ICU

To assess effects of the simulation education on the group intubating patients in the iCU, in this prospective study investigators will video-record real-life intubations and simulations. From videos will be assessed correlation of technical and non-technical skills before and after the education and performance in real-life vs simulation intubation.

Study Overview

• Status: Completed
• Conditions: Airway Management
• Intervention / Treatment: Behavioral: simulation education

Detailed Description

The aim of this trial is to study the effects of simulation education on the action of the group managing patient's airway in the intensive care unit (ICU). Before simulations investigators will video-record 20 real-world intubations. Consequently will be run simulations to whole staff of the ICU. After the education further 20 real-world intubations will be recorded. Also simulations are recorded. From the videos investigators assess technical and non-technical skills of the group before and after simulation education, correlations between groups and influence of the education on action of the group. On the first part of the study, hypothesis is that group's good non-technical skills improve also technical skills. On the second part of the study hypothesis is that performing well in simulation correlates with performing well in real-world situation and teams with less experience the correlation is stronger.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Lahti, Finland, 15850
    • PaijatHame Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-intubations in the icu operated by staff who have given informed consent to this study

Exclusion Criteria:

• intubations in the icu operated by anybody who have rejected video-recording
• intubations in the icu, when patient or patient being unable, close relative has denied permission to use video in this study
• intubated patient is a child, a prisoner, under military service, under forensic psychiatric evaluation, or patient can't give informed consent for example because of the cognitive impairment
• patient is isolated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Staff of the ICU; The whole staff (nurses and doctors) of the ICU will be recruited to this trial. When they give their informed consent, video-recording of the intubations will be started. After 20 videos, simulations will be run. Also simulations will be recorded. Thereafter 20 further real-life intubations will be recorded. Staff intubating patients before and after won't be same but they will be adjusted for experience related to intubations.

Behavioral: simulation education; Intubation protocol will be trained by simulation exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation between technical and non-technical skills	Investigators will study if technical and non-technical skills assessed with appropriate measurement tool like ANTS and JIT-PAPPS will correlate before and after simulation education	2 years
correlation of group performance between simulation and real-life intubations	Investigators will study if technical and non-technical skills assessed with appropriate measurement tool like ANTS and JIT-PAPPS will correlate between simulation intubations and real-life intubations adjusted for experience of the group	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of the group performance	Investigators will study if technical and non-technical skills assessed with appropriate measurement tool like ANTS and JIT-PAPPS will change after the simulation intervention	2 years

Collaborators and Investigators

• Sponsor: Joint Authority for Päijät-Häme Social and Health Care
• Collaborators: University of Turku
• Investigators: Principal Investigator: Miretta Tommila, University of Turku

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2020
• Primary Completion (Actual): November 7, 2022
• Study Completion (Actual): November 7, 2022

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: September 18, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: simulation; education; airway management; intubation; video-record; checklist
• Other Study ID Numbers: 0151/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: available on reasonable request excluded videos
• IPD Sharing Time Frame: from now on till 10 years after study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No