Communication Strategies for Mechanically Ventilated Patients in Intensive Care Units
NCT ID: NCT05651984
Last Updated: 2022-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2019-02-09
2019-06-27
Brief Summary
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Detailed Description
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The health professionals sample size is estimated by convenience to 100 professionals based on the accessible population in the study site (i.e., 95% of the health professionals from the study site). The patients sample size is estimated to 44 patients based on statistical calculation (with a type 1 error rate of 5%, a type 2 error rate of 10% and an allocation ratio of 1), including two groups of 22 patients.
Intervention:
The cross-sectional part involved the healthcare professionals through the "state of the art questionnaire" and the patients through the "ease of communication scale". The crossover part then randomized the patients from the cross-sectional part into two groups and the communication interfaces were divided into two time periods: group A received eye tracking/communication board sequence and group B received communication board/eye tracking sequence. For each period, the communication interfaces were evaluated through the "intervention form". The communication board provides simple messages based on orthographic and iconic content. The eye tracking computer-based system enables the production and construction of simple or complex messages (including word processing with spelling suggestions and voice synthesis), also based on orthographic and iconic content.
Statistical analysis:
The numerical data will be analyzed quantitatively using R software (version 2016 3.5.3). The Gaussian distribution will be estimated by mean/median comparison, histogram symmetry, quantile-quantile distribution and shapiro-wilk test. Statistical analysis of the crossover variables (treatment-period interaction, period effect, and treatment effect) will be performed using the Mann-Whitney (ordinal variables) and chi-square (binary variables) nonparametric tests. A p-value less than 0.05 was considered significant. The non-numerical data will be analyzed qualitatively by thematization and categorization.
Ethics approval and consent to participate:
The study protocol was approved by the Ethics Committee of the Hospital of Liège as Central Committee and the Hospital of Charleroi as Local Committee (number: B70720183767, reference: 2018/268). The information and consent documents intended for healthcare professionals and patients were validated by both Ethics Committees. Written informed consent was obtained from all participants (healthcare professionals and patient's legal representative) included in this study. All procedures performed through this study were in accordance with the 1964 Helsinki Declaration and its later amendments.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Communication board
The communication board consists of a printed paper interface with a size of 42 x 30 cm.
Comparison between communication board and eye tracking
The comparison between the communication board and eye tracking, conducted as a crossover, generates a randomization of the patients (from the cross-sectional part) into two groups and the communication interfaces were divided into two time periods: group A received eye tracking/communication board sequence and group B received communication board/eye tracking sequence.
Eye tracking
The eye tracking device combines a laptop computer with a screen size of 29 x 16 cm, an eye tracker (PCEye Mini, Tobii dynavox, Danderyd, Sweden), an interface generated by a communication software (Communicator 5, Tobii dynavox) and a telescopic support.
Comparison between communication board and eye tracking
The comparison between the communication board and eye tracking, conducted as a crossover, generates a randomization of the patients (from the cross-sectional part) into two groups and the communication interfaces were divided into two time periods: group A received eye tracking/communication board sequence and group B received communication board/eye tracking sequence.
Interventions
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Comparison between communication board and eye tracking
The comparison between the communication board and eye tracking, conducted as a crossover, generates a randomization of the patients (from the cross-sectional part) into two groups and the communication interfaces were divided into two time periods: group A received eye tracking/communication board sequence and group B received communication board/eye tracking sequence.
Eligibility Criteria
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Inclusion Criteria
* Being hospitalized in the intensive care unit (study site),
* Awake with a Richmond Agitation-Sedation Scale (RASS) between "restless" (+1) and "drowsy" (-1),
* Age of 18 years or older,
* French speaker.
Exclusion Criteria
* Lack of consent,
* Severe visual impairment (e.g., blindness).
18 Years
ALL
No
Sponsors
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CHU de Charleroi
OTHER
University Hospital, Tours
OTHER
University of Liege
OTHER
Responsible Party
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Emilie Szymkowicz
ICU nurse
Principal Investigators
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Stephan Ehrmann, MD, PhD
Role: STUDY_DIRECTOR
University hospital and University of Tours
Laetitia Bodet-Contentin, MD, PhD
Role: STUDY_DIRECTOR
University hospital and University of Tours
Yoann Marechal, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University hospital of Charleroi
Emilie Szymkowicz, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Liege
Locations
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University of Liège
Liège, , Belgium
Countries
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References
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Ten Hoorn S, Elbers PW, Girbes AR, Tuinman PR. Communicating with conscious and mechanically ventilated critically ill patients: a systematic review. Crit Care. 2016 Oct 19;20(1):333. doi: 10.1186/s13054-016-1483-2.
Garry J, Casey K, Cole TK, Regensburg A, McElroy C, Schneider E, Efron D, Chi A. A pilot study of eye-tracking devices in intensive care. Surgery. 2016 Mar;159(3):938-44. doi: 10.1016/j.surg.2015.08.012. Epub 2015 Sep 8.
Bodet-Contentin L, Gadrez P, Ehrmann S. Eye-tracking and speech-generating technology to improve communication with intubated intensive care unit patients: initial experience. Intensive Care Med. 2018 May;44(5):676-677. doi: 10.1007/s00134-018-5093-0. Epub 2018 Mar 3. No abstract available.
Miglietta MA, Bochicchio G, Scalea TM. Computer-assisted communication for critically ill patients: a pilot study. J Trauma. 2004 Sep;57(3):488-93. doi: 10.1097/01.ta.0000141025.67192.d9.
Maringelli F, Brienza N, Scorrano F, Grasso F, Gregoretti C. Gaze-controlled, computer-assisted communication in Intensive Care Unit: "speaking through the eyes". Minerva Anestesiol. 2013 Feb;79(2):165-75. Epub 2012 Nov 22.
Other Identifiers
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B707201837671
Identifier Type: -
Identifier Source: org_study_id