EndoscopyEndoComNCT04680858
Impact of Digital Communication Assist Tools in Endoscopic Team Communication During COVID-19
A study testing DECT in people with Endoscopy and Communication, run by University of Ulm at 1 site in Germany.
Trial summary
Team work is highly challenged by the COVID-19 pandemic. Necessary protective equipment as FFP-mask and face shields impair communication significantly.Objective of the study is to evalaute the impact of digital enhanced telecommunication in endoscopic procedures. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Endoscopy, Communication
- What is being tested?
- DECT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2020to 15 Feb 2021
- 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 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Member of staff of the endoscopic team (Doctor, nurse)
Who cannot join
- Deafness
- significantly impaired hearing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Digital Enhanced Telecommunication for Team Communication in Endoscopic Procedures During COVID-19 Pandemic
Team work is highly challenged by the COVID-19 pandemic. Necessary protective equipment as FFP-mask and face shields impair communication significantly.Objective of the study is to evalaute the impact of digital enhanced telecommunication in endoscopic procedures.
Read the detailed description
Optimal communication is crucial for team work in high class endoscopy. Team work is highly challenged by the COVID-19 pandemic. Necessary protective equipment as FFP-mask and face shields impair communication significantly. Digital enhanced approaches to maintain team communication during endoscopic procedures are mandatory not only in actual circumstances.
Materials and methods:A prospective, two-armed interventional study will be performed at an endoscopy unit at a tertiary center. 200 endoscopic examinations (EGD, colonoscopy, EUS, ERCP) were randomly assigned (1:1) to a group that was performed with DECT equipped endoscopy team or with standard communication. All examinations were performed under protective equipment. Primary outcome was rate of communication associated adverse events. Secondary outcomes included team subjectively perceived comfort with DECT enhanced communication during endoscopic work, duration of examinations, SAE.
- Conditions
- Endoscopy, Communication
- Being tested
- DECT
- Keywords
- endoscopy, team communication, endoscopic procedure, COVID-19
- Medical subject headings
- Communication, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DECTOther
Use of a digital enhanced telecommunication headset for team communication
| Study group | Role | What they receive |
|---|---|---|
| Standard Communication | No intervention | Endoscopic procedures performed by skilled endoscopic team with standard communication (no headset) |
| DECT enhanced Communication | Experimental | Endoscopic procedures performed by skilled endoscopic team with enhanced communication tools ( DECT headset) Receives: Other: DECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Communication associated adverse events
Adverse events arising from impaired communication by COVID-19 protection equipment
Measured: From start to stop of endoscopic procedure
Secondary outcomes (3)
Severe adverse events
Severe adverse evatent, not arising from from impaired communication by COVID-19 protection equipment
Measured: From start to stop of endoscopic procedure
Subjective Comfort of DECT communication
Subjectiveley perceived level of comfort using DECT communication during endoscopic procedures rated by numeric rating scale (1-6)
Measured: From start to stop of endoscopic procedure
Endoscopic time
Duration of performed endoscopic procedures
Measured: From start to stop of endoscopic procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start1 Jul 2020
- Primary completion31 Jan 2021 (estimated)
- Study completion15 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndoscopyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-armed study
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Seufferlein, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680858
- Sponsor's protocol ID
- 122020
- Acronym
- EndoCom
- Status last verified
- Dec 2020
- First submitted
- 17 Dec 2020
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Digital Enhanced Telecommunication for Team Communication in Endoscopic Procedures During COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04680858
- Acronym / sponsor ID
- EndoCom / 122020
- Conditions
- Endoscopy, Communication
- Keywords
- endoscopy, team communication, endoscopic procedure, COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 15 Feb 2021 (estimated)
- First posted
- 23 Dec 2020 (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.
Team work is highly challenged by the COVID-19 pandemic. Necessary protective equipment as FFP-mask and face shields impair communication significantly.Objective of the study is to evalaute the impact of digital enhanced telecommunication in endoscopic procedures.
Detailed description
Optimal communication is crucial for team work in high class endoscopy. Team work is highly challenged by the COVID-19 pandemic. Necessary protective equipment as FFP-mask and face shields impair communication significantly. Digital enhanced approaches to maintain team communication during endoscopic procedures are mandatory not only in actual circumstances.
Materials and methods:A prospective, two-armed interventional study will be performed at an endoscopy unit at a tertiary center. 200 endoscopic examinations (EGD, colonoscopy, EUS, ERCP) were randomly assigned (1:1) to a group that was performed with DECT equipped endoscopy team or with standard communication. All examinations were performed under protective equipment. Primary outcome was rate of communication associated adverse events. Secondary outcomes included team subjectively perceived comfort with DECT enhanced communication during endoscopic work, duration of examinations, SAE.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-armed study
| Arm | Type | Receives |
|---|---|---|
| Standard Communication | No intervention | –Endoscopic procedures performed by skilled endoscopic team with standard communication (no headset) |
| DECT enhanced Communication | Experimental | Other: DECTEndoscopic procedures performed by skilled endoscopic team with enhanced communication tools ( DECT headset) |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Member of staff of the endoscopic team (Doctor, nurse)
Key exclusion criteria (2 listed)
- Deafness
- significantly impaired hearing
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 |
|---|---|---|
| DECTUse of a digital enhanced telecommunication headset for team communication | Other | DECT enhanced Communication |
Primary outcome
Communication associated adverse events
Time frame: From start to stop of endoscopic procedure
Adverse events arising from impaired communication by COVID-19 protection equipment
3 secondary outcomes
Severe adverse events
Time frame: From start to stop of endoscopic procedure
Subjective Comfort of DECT communication
Time frame: From start to stop of endoscopic procedure
Endoscopic time
Time frame: From start to stop of endoscopic procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DECT in people with Endoscopy and Communication, run by University of Ulm at 1 site in Germany.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 31 Dec 2020. 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 Germany. 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?
Results are not available in the source record.
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?
Communication associated adverse events (time frame: From start to stop of endoscopic procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2020.