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Completed

NCT Number: NCT05176457

Communication Tool Evaluation on Intensive Care Patients.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Toulouse

Toulouse, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

communication tool PICT'REA

Other

The pictograms communication tool "PICT'REA" will be available to patients with invasive ventilation systems preventing them from speaking

Primary outcomes

  1. Ease of Communication

    Time frame: before PICT'REA introduction (Baseline)

    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 traditional communication methods (slate, alphabet, lip reading, etc.)

  2. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: PICT'REA

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 4, 2022
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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