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Completed

NCT Number: NCT05651984

Communication Strategies for Mechanically Ventilated Patients in Intensive Care Units

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.

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Key information

Conditions

Mechanical Ventilation Complication Behavior Communication Communication, Nonverbal Nonverbal Communication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Liège

Liège, 4000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

- healthcare professionals:

  • Working in the intensive care unit (study site).

Exclusion criteria

- healthcare professionals:

  • Lack of consent.

Inclusion criteria

- patients:

  • 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

- patients:

  • Lack of consent,
  • Severe visual impairment (e.g., blindness).

Treatment and study plan

Comparison between communication board and eye tracking

Device

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.

Primary outcomes

  1. State of the art questionnaire - communication difficulties related to mechanical ventilation as experienced by healthcare professionals.

    Time frame: 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.

  2. Ease of communication scale (ECS) - communication difficulties related to mechanical ventilation as experienced by patients.

    Time frame: 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.

  3. Quantity of messages transmitted through the communication board.

    Time frame: During the use of communication interfaces.

    Communication effectiveness indicator, collected through the intervention form.

  4. Quantity of messages transmitted through the eye tracking.

    Time frame: During the use of communication interfaces.

    Communication effectiveness indicator, collected through the intervention form.

  5. Success rate for the communication board.

    Time frame: During the use of communication interfaces.

    Communication effectiveness indicator, collected through the intervention form.

  6. Success rate for the eye tracking.

    Time frame: During the use of communication interfaces.

    Communication effectiveness indicator, collected through the intervention form.

  7. Level of satisfaction for the communication board.

    Time frame: During the use of communication interfaces.

    Communication effectiveness indicator, collected through the intervention form.

  8. Level of satisfaction for the eye tracking.

    Time frame: During the use of communication interfaces.

    Communication effectiveness indicator, collected through the intervention form.

  9. Communication content for the communication board.

    Time frame: During the use of communication interfaces.

    Communication effectiveness indicator, collected through the intervention form.

  10. Communication content for the eye tracking.

    Time frame: During the use of communication interfaces.

    Communication effectiveness indicator, collected through the intervention form.

  11. Difficulties of use related to the communcation board.

    Time frame: During the use of communication interfaces.

    Communication effectiveness indicator, collected through the intervention form.

  12. Difficulties of use related to the eye tracking.

    Time frame: During the use of communication interfaces.

    Communication effectiveness indicator, collected through the intervention form.

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Collaborators

  • CHU de Charleroi
  • University Hospital, Tours

Registry information

Official study title

Comparative Analysis of Communication Board and Eye Tracking in Intensive Care Mechanically Ventilated Patients

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 15, 2022
Registry last updated
Dec 15, 2022

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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