Service Médecine Intensive Réanimation Tenon Hospital
Paris, 75020, France
NCT Number: NCT07776795
Hospitalization in an intensive care unit (ICU) is accompanied by major physical and emotional stress for patients, a source of discomfort and a risk factor for post-resuscitation syndrome. Efficient patient-caregiver and patient-family communication is needed to: understand the patient's symptoms in order to relieve them, understand the patient's primary needs, understand the patient's questions and concerns in order to respond to them, rehumanize our care and re-establish a more balanced relationship with the patient. However, communication with the patient is often limited, due for example to invasive mechanical ventilation: it is estimated that half of intubated patients meet basic communication criteria (calm patient responding to simple commands and verbal requests) after 2 days of mechanical ventilation, without however being able to express themselves verbally.
Augmentative and alternative communication tools exist, ranging from pictograms and slates to voice synthesizers, and are used in ICU. The critical care departments of the University Hospitals of Marseille and Tours use a communication interface consisting of a mobile screen with eye tracking for vigilant patients unable to communicate verbally, which seems to have been appreciated by patients and their families, although its effect has not been measured.
Connected glasses are one of the tools available. These are pairs of glasses fitted with infrared sensors that detect a signal predefined with the patient (such as a wink) and thus enable a tablet with customized communication software to be clicked on and navigated. Potential advantages over eye tracking, which has already been used in critical care departments, include: use in low-light conditions, smaller size (no need for an arm to adjust screen orientation), less concentration (eye tracking requires precise, sustained eye fixation).
The objective is to conduct a pilot study to assess the feasibility of using this tool in non temporarily speaking patients hospitalized in ICU.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Paris, 75020, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 7 month
This is the median of daily usage times from the beginning to the end of the study. Every day, the actual use of the tool (yes/no) is collected and the use of the connected glasses is timed (thanks to the stopwatch available on the patient monitor).
Time frame: 7 month
Tool installation time (timed by the caregiver interacting with the patient)
Time frame: 7 months
reason for not using the tool (change in patient condition temporarily incompatible with use of the tool, occurrence of malfunctions)
Time frame: 1 month
satisfaction questionnaire and profile (age, gender, function) of the member of the care team in charge of the patient
Time frame: 7 months
occurrence of malfunctions (yes/no)
Time frame: 7 months
type of malfunction (technical failure, battery not charged, unfamiliarity of caregivers with the tool, lack of space or inappropriate positioning of the tool, lack of caregiver time)
Time frame: 1 month
Communication ease questionnaire (10-item Ease of Communication Scale using a 5-level Likert scale, previously validated in psychometrics)
Time frame: 1 month
satisfaction questionnaire and profile (age, sex) of the doctor in charge of the patient, administration of psychotropic drugs (molecules and doses)
Time frame: 1 month
use of physical restraint (yes/no)
Contact information is provided by the study sponsor or research team.
Aude GIBELIN, PhD
CONTACT
Audrey BARON, PhD
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Acronym: CASTOR-REA
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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