Simulation Training and Teamwork Concerning Intubation on the Icu

NCT04564105 | Completed

• 1 other identifier: 0151/2020
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Management

Keywords

intubation; simulation; airway management; education; video-record; checklist

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• change of the group performance

  2 years

Study Arms (1)

Staff of the ICU

OTHER

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

Interventions

simulation education BEHAVIORAL

Intubation protocol will be trained by simulation exercise.

Staff of the ICU

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Joint Authority for Päijät-Häme Social and Health Care: lead
• University of Turku: collaborator

Study Sites (1)

PaijatHame Central Hospital

Lahti, 15850, Finland

Location

Study Officials

• Miretta Tommila

  University of Turku

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 25, 2020
• Study Start: September 4, 2020
• Primary Completion: November 7, 2022
• Study Completion: November 7, 2022
• Last Updated: March 15, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: from now on till 10 years after study

Locations

FI (1)