The use of the eye tracking technique for non-verbal communication with intubated and mechanical ventilated patients in the intensive care unit
Organizational Data
- DRKS-ID:
- DRKS00021233
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2020-04-23
- Last update in DRKS:
- 2022-10-31
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
The use of the eye tracking technique for non-verbal communication with intubated and mechanical ventilated patients in the intensive care unit
Brief summary in scientific language
Eye tracking (ET) may be a novel tool for non-verbal communication with intubated and mechanically ventilated critically ill patients. We hypothesized that ET could be learned fast and be used successfully by intensive care unit (ICU) and intermediate care (IMC) patients with artificial airways for non-verbal communication.
Health condition or problem studied
- Free text:
- Intubated and mechanically ventilated patients because of ARDS, Weaning or surgical diseases
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- We want to investigate the application of the eye tracking technology as a tool for non-verbal communication in intubated and mechanically ventilated patients in a surgical intensive care unit. A standardized study protocol is used to answer questions and scores of basic needs. Eligible patients are examined from Monday to Friday between 10 a.m. and 2 p.m. The examinations will be stopped when the patient requested it or if eye contact is no longer possible. On the following day the examination will be resumed with the last question that could not be answered. All patients who completed the study protocol will be included, regardless of the required number of sessions.
Endpoints
- Primary outcome:
- The primäry outcome measurement was to test the clinical applicability of ETs for non-verbal communication with intubated and mechanically ventilated patients in the surgical ICU and surgical IMC.
- Secondary outcome:
- Use of eye tracking in intubated and ventilated patients in the ICU during delirium, to record painkiller therapy and to improve tracheal cannula management
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Bergmannsheil Bochum, chirurgische Intensivstation Bochum
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2020-02-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2020-11-30
- Target Sample Size:
- 65
- Final Sample Size:
- 75
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Included were: (1) endotracheal tube or tracheostomy tube and mechanical ventilation; (2) over 18 years of age; (3) a score of -1, 0 or 1 points on the Richmond agitation-sedation scale (RASS) or a score of < 3 points on the nursing delirium screening scale (Nu-DESC) in patients without sedation; (4) a history of mechanical ventilation of more than 48 hours; (5) expecting to be ventilated for the next 24 hours; and (6) inadequate nonverbal communication skills.
Exclusion Criteria
Excluded were all patients with a tracheostomy tube, who were able to speak more than 6 hours per day with unblocked cuff.
Addresses
Primary Sponsor
- Address:
- Chirurgische Universitätsklinik und PoliklinikBerufsgenossenschaftliches Universitätsklinikum BergmannsheilUniv.-Prof. Dr. med. Thomas SchildhauerBürkle-de-la-Camp-Platz 14789 BochumGermany
- Telephone:
- 0234 302-3200
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bergmannsheil.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- BG Universitätsklinikum BergmannsheilDr. med. Christopher UllBürkle-de-la-Camp-Platz 144789 BochumGermany
- Telephone:
- 0234 302-3576
- Fax:
- 0234 302-6045
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bergmannsheil.de
Contact for Public Queries
- Address:
- BG Universitätsklinikum BergmannsheilDr. med. Christopher UllBürkle-de-la-Camp-Platz 144789 BochumGermany
- Telephone:
- 0234 302-3576
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bergmansheil.de
Principal Investigator
- Address:
- BG Universitätsklinikum BergmannsheilDr. med. Christopher UllBürkle-de-la-Camp-Platz 144789 BochumGermany
- Telephone:
- 0234 302-3576
- Fax:
- 0234 302-6045
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bergmannsheil.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbHBürkle-de-la-Camp-Platz 144789 BochumGermany
- Telephone:
- 0234 302-3576
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bergmannsheil.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität BochumGesundheitscampus 3344801 BochumGermany
- Telephone:
- +49-234-79816555
- Fax:
- +49-234-79816556
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2019-04-20
- Ethics committee number:
- 18-6620-BR
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2019-08-07
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry