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Clinical Trials/NCT05176457
NCT05176457
Completed
Not Applicable

A Communication Tool's Evaluation on Intensive Care Patients Equipped With Ventilation Systems.

University Hospital, Toulouse1 site in 1 country94 target enrollmentStarted: December 13, 2021Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
94
Locations
1
Primary Endpoint
Ease of Communication

Overview

Brief Summary

The present study evaluate the impact of a communication tool "PICT'REA" on patients in reanimation units, equipped with ventilation systems, preventing them from speaking.

The app consists of simple pictograms allowing simple communication between patients and the reanimation care team.

The study will assess the quality of communication before and after the introduction of the communication tool in the reanimation unit.

Detailed Description

Invasive mechanical ventilation is commonly used in intensive care, in sedated patients but also in perfectly conscious patients, and this on a daily basis.

For these patients, the resulting deprivation of oral expression is a major source of stress and discomfort. On the side of the caregivers, the difficulty of comprehension is a source of frustration on a daily basis.

Thus PICT'REA has been developped in order to help patients and caregivers to better understand each other during invasive ventilation.

PICT'REA is a tool in the form of a mobile app with simple pictograms allowing simple communication (Yes/No/Pain chart...).

The study will analyze the quality of communication between patients and caregivers before and after the introduction of the application:

  • Before setting up the tool: control group

  • Over a period of 6 months

  • In the multi-purpose resuscitations of Cardio Vascular Surgery and Neurosurgery.

  • After setting up the tool:

  • Over a period of 6 months

  • In the same departments.

The analyses consists of various questionnaires :

  • the modified Ease of Communication Scale,
  • a Short questionnaire in 3 questions for caregivers,
  • IPREA questionnaire for patients,
  • Evaluation of the usability of the system by System Usability Scale questionnaire,
  • Evaluation of the attractiveness of the system by Attrackdiff questionnaire.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Hospitalized in intensive care or intensive care
  • ventilated on a tracheostomy or an orotracheal intubation tube for\> 24 hours
  • not too agitated or too sedated (RASS -1 to +2) for\> 24 hours
  • Confusion Assessment Method (CAM) ICU negative
  • Speak or read French

Exclusion Criteria

  • Inability to use the device:
  • Blind or visually impaired
  • Severe paresis of the upper limbs
  • No understanding of the tool.

Outcomes

Primary Outcomes

Ease of Communication

Time Frame: after PICT'REA introduction (6 months)

The modified Ease of Communication Scale (ECS), comprising 8 questions of 1 to 5 points, for a maximum total of 40 points. The lower the score, the easiest the communication is. This is regarding patients using the PICT REA application.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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