Use of Connected Glasses to Help the Communication of Non Temporarily Speaking Patients in Intensive Care Unit : a Pilot Study (CASTOR-REA)
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.
Studieoversigt
Status
Detaljeret beskrivelse
- The main objective of this pilot study is to evaluate the ability of ICU patients, who are vigilant but unable to communicate verbally, to use connected glasses as a communication aid.
- The secondary objectives are to assess the limitations to the use of the communication aid and to measure the qualitative and quantitative impact of the communication tool.
- Course of the study : Participation in the study is offered to any patient hospitalized in the department for a foreseeable period of ≥ 48 hours and whose clinical condition corresponds to the selection criteria. After oral and written information, the patient's non-opposition is collected and consigned in the information notice in the patient's file. Calibration of the connected glasses is carried out with the patient by trained medical and nursing staff (choice of personalized signal to control the cursor on the electronic tablet). Then, the connected glasses are put on the patient by the medical and nursing staff for an exchange session facilitated by the communication interface (no predefined duration): at least at each monitoring round (every 4 hours except during the night round if the patient is asleep) and during the medical visit each morning. Installation and actual use times are timed. Outcomes (see below) are collected on a Case Report Form (CRF) at the patient's bedside. Use of the connected glasses is temporarily suspended if the patient's condition no longer allows him/her to use it (onset of confusion, change in neurological status, deterioration in helath state). It may be resumed if the patient's condition subsequently improves.
The study ends:
- when the patient is able to communicate verbally (e.g. extubation, decanulation) or using the slate (e.g. recovery of sufficient motor skills to use the slate correctly);
- or when the patient is discharged from the ICU;
- or after a maximum of 1 month's use of the tool for each patient.
- After the study : there is no other data collected, the patient will not be contacted relating to the study.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Audrey BARON, PhD
- Telefonnummer: +33 1 56 01 51 84
- E-mail: audreypaule.baron@aphp.fr
Undersøgelse Kontakt Backup
- Navn: Aude GIBELIN, PhD
- Telefonnummer: + 33 1 56 01 50 29
- E-mail: aude.gibelin@aphp.fr
Studiesteder
-
-
-
Paris, Frankrig, 75020
- Service Médecine Intensive Réanimation Tenon Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Adult patients hospitalized in the Intensive Care Medicine Department of the Tenon Hospital, whatever their reason for admission to the department
- Neuropsychiatric state compatible with the development of a coherent dialogue: good vigilance attested by a RASS -1 to +1 (Richmond Agitation Sedation Scale), no confusion attested by a negative CAM-ICU test (Confusion Assessment Method for the Intensive Care Unit), no sedative treatment or light sedative treatment
- Physically unable to communicate verbally for a foreseeable period of at least 48 hours, which may be linked to invasive mechanical ventilation (with endotracheal tube or tracheotomy without phonatory cannula) or to a speech and/or phonation disorder whatever the cause (eg: after-effects of ENT surgery, laryngeal oedema, etc.).
- Have expressed no objection to participating in the study.
Exclusion Criteria:
- Neuropsychiatric state incompatible with the development of a coherent dialogue: agitation (RASS ≥ 2) or somnolence (RASS ≤ -2), confusion (CAM-ICU positive)
- Simple, fluid appropriation by the patient of the slate as a communication tool : no motor deficit of the dominant upper limb, no graphic problems, no language barrier
- Inability of patient to use connected glasses: blindness, eye conditions preventing eye opening, vision disorders without corrective lenses available, known patent cognitive disorders, mental retardation
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Median daily time spent actually using the connected glasses during the study.
Tidsramme: 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).
|
7 month
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
To assess limitations to the tool use
Tidsramme: 7 month
|
Tool installation time (timed by the caregiver interacting with the patient)
|
7 month
|
|
To assess limitations to the tool use
Tidsramme: 7 months
|
reason for not using the tool (change in patient condition temporarily incompatible with use of the tool, occurrence of malfunctions)
|
7 months
|
|
To assess limitations to the tool use
Tidsramme: 1 month
|
satisfaction questionnaire and profile (age, gender, function) of the member of the care team in charge of the patient
|
1 month
|
|
To assess limitations to the tool use
Tidsramme: 7 months
|
occurrence of malfunctions (yes/no)
|
7 months
|
|
To assess limitations to the tool use
Tidsramme: 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)
|
7 months
|
|
To assess the qualitative and quantitative impact of the communication tool
Tidsramme: 1 month
|
Communication ease questionnaire (10-item Ease of Communication Scale using a 5-level Likert scale, previously validated in psychometrics)
|
1 month
|
|
To assess the qualitative and quantitative impact of the communication tool
Tidsramme: 1 month
|
satisfaction questionnaire and profile (age, sex) of the doctor in charge of the patient, administration of psychotropic drugs (molecules and doses)
|
1 month
|
|
To assess the qualitative and quantitative impact of the communication tool
Tidsramme: 1 month
|
use of physical restraint (yes/no)
|
1 month
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Audrey BARON, PhD, Assistance Publique - Hôpitaux de Paris
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- APHP250022
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .