Communication Strategies for Mechanically Ventilated Patients in Intensive Care Units

Mechanical Ventilation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05651984
• Other study ID #: B707201837671
• Status: Completed
• Phase: N/A
• Start date: February 9, 2019
• Est. completion date: June 27, 2019

Study information

• Verified date: December 2022
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 27, 2019
• Est. primary completion date: June 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Mechanical Ventilation Complication

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Belgium	University of Liège	Liège

Sponsors (3)

Lead Sponsor	Collaborator
University of Liege	CHU de Charleroi, University Hospital, Tours

Country where clinical trial is conducted

Belgium, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	State of the art questionnaire - communication difficulties related to mechanical ventilation as experienced by healthcare professionals.	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.	Before the use of communication interfaces.
Primary	Ease of communication scale (ECS) - communication difficulties related to mechanical ventilation as experienced by patients.	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.	Before the use of communication interfaces.
Primary	Quantity of messages transmitted through the communication board.	Communication effectiveness indicator, collected through the intervention form.	During the use of communication interfaces.
Primary	Quantity of messages transmitted through the eye tracking.	Communication effectiveness indicator, collected through the intervention form.	During the use of communication interfaces.
Primary	Success rate for the communication board.	Communication effectiveness indicator, collected through the intervention form.	During the use of communication interfaces.
Primary	Success rate for the eye tracking.	Communication effectiveness indicator, collected through the intervention form.	During the use of communication interfaces.
Primary	Level of satisfaction for the communication board.	Communication effectiveness indicator, collected through the intervention form.	During the use of communication interfaces.
Primary	Level of satisfaction for the eye tracking.	Communication effectiveness indicator, collected through the intervention form.	During the use of communication interfaces.
Primary	Communication content for the communication board.	Communication effectiveness indicator, collected through the intervention form.	During the use of communication interfaces.
Primary	Communication content for the eye tracking.	Communication effectiveness indicator, collected through the intervention form.	During the use of communication interfaces.
Primary	Difficulties of use related to the communcation board.	Communication effectiveness indicator, collected through the intervention form.	During the use of communication interfaces.
Primary	Difficulties of use related to the eye tracking.	Communication effectiveness indicator, collected through the intervention form.	During the use of communication interfaces.