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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04564105
Other study ID # 0151/2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 4, 2020
Est. completion date November 7, 2022

Study information

Verified date January 2023
Source Joint Authority for Päijät-Häme Social and Health Care
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date November 7, 2022
Est. primary completion date November 7, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Finland PaijatHame Central Hospital Lahti

Sponsors (2)

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

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
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