Simulation Training and Teamwork Concerning Intubation on the Icu

Sponsor

Joint Authority for Päijät-Häme Social and Health Care (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04564105

Collaborator

University of Turku (Other)

Enrollment

Location

Arm

63.9

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Airway Management	Behavioral: simulation education	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Sep 4, 2020

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

correlation between technical and non-technical skills [2 years]
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
correlation of group performance between simulation and real-life intubations [2 years]
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

Secondary Outcome Measures

change of the group performance [2 years]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PaijatHame Central Hospital	Lahti		Finland	15850

Sponsors and Collaborators

Joint Authority for Päijät-Häme Social and Health Care
University of Turku

Investigators

Principal Investigator: Miretta Tommila, University of Turku

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joint Authority for Päijät-Häme Social and Health Care

ClinicalTrials.gov Identifier:

NCT04564105

Other Study ID Numbers:

0151/2020

First Posted:

Sep 25, 2020

Last Update Posted:

Jan 12, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Joint Authority for Päijät-Häme Social and Health Care

Study Results

No Results Posted as of Jan 12, 2022