Mechanical Ventilation ComplicationNCT05651984
Communication Strategies for Mechanically Ventilated Patients in Intensive Care Units
A study testing Comparison between communication board and eye tracking in people with Mechanical Ventilation Complication and Communication, Nonverbal, run by University of Liege at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication, Communication, Nonverbal
- What is being tested?
- Comparison between communication board and eye tracking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Feb 2019to 27 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Working in the intensive care unit (study site).
- 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.
Who cannot join
- Lack of consent.
- Lack of consent,
- Severe visual impairment (e.g., blindness).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Analysis of Communication Board and Eye Tracking in Intensive Care Mechanically Ventilated Patients
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.
Read the 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.
- Being tested
- Comparison between communication board and eye tracking
- Keywords
- Intensive care unit, Mechanical ventilation, Alternative communication, Eye tracking, Communication board
- Medical subject headings
- Nonverbal Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison between communication board and eye trackingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Communication board | Active comparator | The communication board consists of a printed paper interface with a size of 42 x 30 cm. Receives: 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. Receives: Device: Comparison between communication board and eye tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Before the use of communication interfaces.
Quantity of messages transmitted through the communication board.
Communication effectiveness indicator, collected through the intervention form.
Measured: During the use of communication interfaces.
Quantity of messages transmitted through the eye tracking.
Communication effectiveness indicator, collected through the intervention form.
Measured: During the use of communication interfaces.
Success rate for the communication board.
Communication effectiveness indicator, collected through the intervention form.
Measured: During the use of communication interfaces.
Success rate for the eye tracking.
Communication effectiveness indicator, collected through the intervention form.
Measured: During the use of communication interfaces.
Level of satisfaction for the communication board.
Communication effectiveness indicator, collected through the intervention form.
Measured: During the use of communication interfaces.
Level of satisfaction for the eye tracking.
Communication effectiveness indicator, collected through the intervention form.
Measured: During the use of communication interfaces.
Communication content for the communication board.
Communication effectiveness indicator, collected through the intervention form.
Measured: During the use of communication interfaces.
Communication content for the eye tracking.
Communication effectiveness indicator, collected through the intervention form.
Measured: During the use of communication interfaces.
Difficulties of use related to the communcation board.
Communication effectiveness indicator, collected through the intervention form.
Measured: During the use of communication interfaces.
Difficulties of use related to the eye tracking.
Communication effectiveness indicator, collected through the intervention form.
Measured: During the use of communication interfaces.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start9 Feb 2019
- Primary completion27 Jun 2019
- Study completion27 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- CHU de Charleroi, University Hospital, Tours
- Responsible party
- Principal investigator, Emilie Szymkowicz, University of Liege
- Investigators
- Stephan Ehrmann, MD, PhD, Study director, University hospital and University of ToursLaetitia Bodet-Contentin, MD, PhD, Study director, University hospital and University of ToursYoann Marechal, MD, PhD, Principal investigator, University hospital of CharleroiEmilie Szymkowicz, MSc, Principal investigator, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651984
- Sponsor's protocol ID
- B707201837671
- Status last verified
- Dec 2022
- First submitted
- 2 Dec 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27756433Garry 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.
PubMed 26361099Bodet-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.
PubMed 29502253Miglietta 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.
PubMed 15454792Maringelli 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.
PubMed 23174919
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Communication Board and Eye Tracking in Intensive Care Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT05651984
- Acronym / sponsor ID
- B707201837671
- Keywords
- Intensive care unit, Mechanical ventilation, Alternative communication, Eye tracking, Communication board
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- CHU de Charleroi, University Hospital, Tours
- Study start
- 9 Feb 2019 (actual)
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- 27 Jun 2019 (actual)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Communication board | Active comparator | Device: Comparison between communication board and eye trackingThe communication board consists of a printed paper interface with a size of 42 x 30 cm. |
| Eye tracking | Experimental | Device: Comparison between communication board and eye trackingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Working in the intensive care unit (study site).
- 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.
Key exclusion criteria (3 listed)
- Lack of consent.
- Lack of consent,
- Severe visual impairment (e.g., blindness).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison between communication board and eye trackingThe 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. | Device | Communication board, Eye tracking |
Primary outcome
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.
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.
Quantity of messages transmitted through the communication board.
Time frame: During the use of communication interfaces.
Communication effectiveness indicator, collected through the intervention form.
Quantity of messages transmitted through the eye tracking.
Time frame: During the use of communication interfaces.
Communication effectiveness indicator, collected through the intervention form.
Success rate for the communication board.
Time frame: During the use of communication interfaces.
Communication effectiveness indicator, collected through the intervention form.
Success rate for the eye tracking.
Time frame: During the use of communication interfaces.
Communication effectiveness indicator, collected through the intervention form.
Level of satisfaction for the communication board.
Time frame: During the use of communication interfaces.
Communication effectiveness indicator, collected through the intervention form.
Level of satisfaction for the eye tracking.
Time frame: During the use of communication interfaces.
Communication effectiveness indicator, collected through the intervention form.
Communication content for the communication board.
Time frame: During the use of communication interfaces.
Communication effectiveness indicator, collected through the intervention form.
Communication content for the eye tracking.
Time frame: During the use of communication interfaces.
Communication effectiveness indicator, collected through the intervention form.
Difficulties of use related to the communcation board.
Time frame: During the use of communication interfaces.
Communication effectiveness indicator, collected through the intervention form.
Difficulties of use related to the eye tracking.
Time frame: During the use of communication interfaces.
Communication effectiveness indicator, collected through the intervention form.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Background: PubMed 27756433Ten 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.
- Background: PubMed 26361099Garry 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.
- Background: PubMed 29502253Bodet-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.
- Background: PubMed 15454792Miglietta 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.
- Background: PubMed 23174919Maringelli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Ehrmann, MD, PhD study director
University hospital and University of Tours
Laetitia Bodet-Contentin, MD, PhD study director
University hospital and University of Tours
Yoann Marechal, MD, PhD principal investigator
University hospital of Charleroi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison between communication board and eye tracking in people with Mechanical Ventilation Complication and Communication, Nonverbal, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State of the art questionnaire - communication difficulties related to mechanical ventilation as experienced by healthcare professionals. (time frame: Before the use of communication interfaces.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05651984, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.