Communication Strategies for Mechanically Ventilated Patients in Intensive Care Units

Not Applicable

Completed

• Conditions: Communication, Nonverbal; Mechanical Ventilation Complication
• Interventions: Device: Comparison between communication board and eye tracking

• Registration Number: NCT05651984
• Lead Sponsor: University of Liege

Brief Summary

This prospective study consisted of (1) a descriptive cross-sectional part describing communication difficulties related to mechanical ventilation as experienced by intensive care professionals and patients, and (2) an experimental randomized crossover part comparing the use of a conventional low-tech communication board and a high-tech eye tracking technology-based device to improve communication effectiveness of intensive care mechanically ventilated patients.

Detailed Description

Sample size:

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.

Study Timeline

• Study Start: 2019-02-09
• Primary Completion: 2019-06-27
• Study Completion: 2019-06-27
• Status Verified: 2022-12
• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2022-12-13
• Last Update Submitted: 2022-12-13
• Study First Posted: 2022-12-15
• Last Update Posted: 2022-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Communication board	Comparison between communication board and eye tracking	The communication board consists of a printed paper interface with a size of 42 x 30 cm.
Eye tracking	Comparison between communication board and 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.

Primary Outcome Measures

Name	Time	Method
Communication content for the eye tracking.	During the use of communication interfaces.	Communication effectiveness indicator, collected through the intervention form.
Difficulties of use related to the communcation board.	During the use of communication interfaces.	Communication effectiveness indicator, collected through the intervention form.
State of the art questionnaire - communication difficulties related to mechanical ventilation as experienced by healthcare professionals.	Before the use of communication interfaces.	Self-administered questionnaire assessing the difficulties to communicate with intubated or tracheostomized patients, the avoidance of interactions with patients, the perception of the help that could be provided by alternative communication systems and the interest in learning to use these systems.
Quantity of messages transmitted through the communication board.	During the use of communication interfaces.	Communication effectiveness indicator, collected through the intervention form.
Success rate for the eye tracking.	During the use of communication interfaces.	Communication effectiveness indicator, collected through the intervention form.
Level of satisfaction for the communication board.	During the use of communication interfaces.	Communication effectiveness indicator, collected through the intervention form.
Difficulties of use related to the eye tracking.	During the use of communication interfaces.	Communication effectiveness indicator, collected through the intervention form.
Ease of communication scale (ECS) - communication difficulties related to mechanical ventilation as experienced by patients.	Before the use of communication interfaces.	Multidimensional scale completed through an assisted interview and covering the difficulty to be understood; to communicate physical needs, thoughts, and feelings with notably relatives, nurses and physicians; and to ask questions about care and health status.
Level of satisfaction for the eye tracking.	During the use of communication interfaces.	Communication effectiveness indicator, collected through the intervention form.
Communication content for the communication board.	During the use of communication interfaces.	Communication effectiveness indicator, collected through the intervention form.
Quantity of messages transmitted through the eye tracking.	During the use of communication interfaces.	Communication effectiveness indicator, collected through the intervention form.
Success rate for the communication board.	During the use of communication interfaces.	Communication effectiveness indicator, collected through the intervention form.

Trial Locations

Locations (1)

University of Liège; 🇧🇪 Liège, Belgium