Clinical trial NCT05176457: Communication Tool Evaluation on Intensive Care Patients.
Official title: A Communication Tool's Evaluation on Intensive Care Patients Equipped With Ventilation Systems.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication, Nonverbal
Keywords: intensive care
communication tool
invasive ventilation
speaking impairment
technology
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ease of Communication
timeFrame: before PICT'REA introduction (Baseline)
measure: Ease of Communication
timeFrame: after PICT'REA introduction (6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Fanny VARDON-BOUNES, MD
role: PRINCIPAL_INVESTIGATOR
References: