Communication Strategies for Mechanically Ventilated Patients in Intensive Care Units

NCT05651984 | Completed

• 1 other identifier: B707201837671
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation Complication; Communication, Nonverbal

Keywords

Intensive care unit; Mechanical ventilation; Alternative communication; Eye tracking; Communication board

Outcome Measures

Primary Outcomes (12)

• 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.

• 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.

• Quantity of messages transmitted through the communication board.

  Communication effectiveness indicator, collected through the intervention form.

  During the use of communication interfaces.

• Quantity of messages transmitted through the eye tracking.

  Communication effectiveness indicator, collected through the intervention form.

  During the use of communication interfaces.

• Success rate for the communication board.

  Communication effectiveness indicator, collected through the intervention form.

  During the use of communication interfaces.

• Success rate for the eye tracking.

  Communication effectiveness indicator, collected through the intervention form.

  During the use of communication interfaces.

• Level of satisfaction for the communication board.

  Communication effectiveness indicator, collected through the intervention form.

  During the use of communication interfaces.

• Level of satisfaction for the eye tracking.

  Communication effectiveness indicator, collected through the intervention form.

  During the use of communication interfaces.

• Communication content for the communication board.

  Communication effectiveness indicator, collected through the intervention form.

  During the use of communication interfaces.

• Communication content for the eye tracking.

  Communication effectiveness indicator, collected through the intervention form.

  During the use of communication interfaces.

• Difficulties of use related to the communcation board.

  Communication effectiveness indicator, collected through the intervention form.

  During the use of communication interfaces.

• Difficulties of use related to the eye tracking.

  Communication effectiveness indicator, collected through the intervention form.

  During the use of communication interfaces.

Study Arms (2)

Communication board

ACTIVE COMPARATOR

The communication board consists of a printed paper interface with a size of 42 x 30 cm.

Device: Comparison between communication board and eye tracking

Eye tracking

EXPERIMENTAL

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.

Device: Comparison between communication board and eye tracking

Interventions

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.

Communication board; Eye tracking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Liege: lead
• CHU de Charleroi: collaborator
• University Hospital, Tours: collaborator

Study Sites (1)

University of Liège

Liège, 4000, Belgium

Location

Related Publications (5)

• 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.

  PMID: 27756433 BACKGROUND

• 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.

  PMID: 26361099 BACKGROUND

• 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.

  PMID: 29502253 BACKGROUND

• 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.

  PMID: 15454792 BACKGROUND

• 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.

  PMID: 23174919 BACKGROUND

MeSH Terms

Conditions

Nonverbal Communication

Interventions

Eye-Tracking Technology

Condition Hierarchy (Ancestors)

Communication; Behavior

Intervention Hierarchy (Ancestors)

Eye Movement Measurements; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Stephan Ehrmann, MD, PhD

  University hospital and University of Tours

  STUDY DIRECTOR

• Laetitia Bodet-Contentin, MD, PhD

  University hospital and University of Tours

  STUDY DIRECTOR

• Yoann Marechal, MD, PhD

  University hospital of Charleroi

  PRINCIPAL INVESTIGATOR

• Emilie Szymkowicz, MSc

  University of Liege

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ICU nurse

Model Details: Intra-individual comparison of 2 "treatments" divided into 2 time periods, so as to constitute 4 experimental conditions. The order of the treatments allocation, organised according to 2 sequences (A-B and B-A), induces a randomisation of the included patients into 2 groups. The wash-out period between the 2 periods is not applicable in this study.

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 15, 2022
• Study Start: February 9, 2019
• Primary Completion: June 27, 2019
• Study Completion: June 27, 2019
• Last Updated: December 15, 2022

Record last verified: 2022-12

Locations

BE (1)