Patients Undergoing Elective Surgery With AnesthesiaNCT04518514
Telemedical Risk Assessment and Preoperative Evaluation (TAPE)
A study testing TAPE-Software in people with Patients Undergoing Elective Surgery With Anesthesia, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The purpose of this study is to assess the feasibility, patient satisfaction and time saving of a telemedical risk assessment and preoperative evaluation for anesthesia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patients Undergoing Elective Surgery With Anesthesia
- What is being tested?
- TAPE-Software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 20 Apr 2020to 30 Nov 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ≥18 years
- estimated ASA I/II classification based on the American Society of Anesthesiologists (ASA) classification
- elective surgery
- surgery at least 14 days in the future
- patient access to a Windows-10-based personal computer with webcam
Who cannot join
- language or cognitive barriers (e.g. dementia, laryngectomy...)
- high risk surgeries with need of postoperative ICU stay
- acute infection with required auscultation
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
RWTH Aachen University Hospital
Aachen, 52074
Andreas Follmann, Dr., 0049 2418036219, afollmann@ukaachen.de
Jan Wienhold, cand. med., 0049 2418036923, jwienhold@ukaachen.de
About this study
Official title: Telemedical Risk Assessment and Preoperative Evaluation for Anesthesia During the COVID-19 Pandemic
The purpose of this study is to assess the feasibility, patient satisfaction and time saving of a telemedical risk assessment and preoperative evaluation for anesthesia.
Read the detailed description
The preanesthesia evaluation and risk assessment is conducted by an anesthesiologist prior to elective surgery. The physician assesses the patient´s medical records and specifies the individual preoperative procedure in order to minimize the perioperative risks. The on-site meeting is often connected with extended travel time and during the COVID-19 pandemic also with an increased infection risk for the patient. This project was initiated to reduce time efforts on patient site and to reduce possible infection risks. The TAPE-software turns every patients home into a remote facility allowing the physician to conduct the preanesthesia evaluation over distance.
- Being tested
- TAPE-Software
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAPE-SoftwareDevice
Telemedical Risk Assessment and Preoperative Evaluation prior to anaesthesia via personal computer
| Study group | Role | What they receive |
|---|---|---|
| Preoperative evaluation and risk assessment via telemedicine | Experimental | Not described Receives: Device: TAPE-Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (as defined below) of telemedical risk assessment and preoperative evaluation in anesthesiology as assessed by a questionnaire.
We focus on the feasibility of a telemedical risk assessment and preoperative evaluation in anesthesiology. We defined feasibility in our scenario as:
- establishment of a video-audio-connection possible
- complete assessment of the patients medical records possible
- assessment of the individual perioperative risk possible
- physician is put into the position to explain planned procedures and related risks
- digital documentation possible
- physician is put into the position to answer patient questions
- physician can acquire all necessary information
- digital signature on both sides possible
Those criteria will be assessed by our questionnaires. After preanesthesia evaluation the patient as well as the physician are asked to answer our online questionnaire (two different ones).
Measured: 6 months
Patient acceptance of a telemedical preanesthesia evaluation as assessed by a questionnaire.
After preanesthesia evaluation the patient is asked to answer our online questionnaire. The questionnaire is partly based on a previously published study (Follmann et al., Technical Support by Smart Glasses During a Mass Casualty Incident: A Randomized Controlled Simulation Trial on Technically Assisted Triage and Telemedical App Use in Disaster Medicine, J Med Internet Res 2019;21(1):e11939).
Measured: 6 months
Patient satisfaction with a telemedical preanesthesia evaluation as assessed by a questionnaire.
We aim to investigate patient satisfaction of a telemedical risk assessment and preoperative evaluation in anesthesiology prior to elective surgery. After preanesthesia evaluation the patient is asked to answer our online questionnaire. The questionnaire is partly based on a previously published study (Follmann et al., Technical Support by Smart Glasses During a Mass Casualty Incident: A Randomized Controlled Simulation Trial on Technically Assisted Triage and Telemedical App Use in Disaster Medicine, J Med Internet Res 2019;21(1):e11939).
Measured: 6 months
Time saving for the patient
We quantify time saving on patient site due to the fact that patients do not have to travel to the hospital anymore.
Measured: 6 months
Time saving for the physician
On physician site we investigate possible time saving due to the implementation of the investigator's software.
Measured: 6 months
Adverse events
Number of patients in whom telemedical preanesthesia evaluation lead to adverse events such as postponed surgery and adverse events during surgery which are caused by the preanesthesia evaluation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start20 Apr 2020
- Primary completion31 Oct 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients Undergoing Elective Surgery With AnesthesiaStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Docs in Clouds Telecare GmbH
- Responsible party
- Principal investigator, Jan Wienhold, RWTH Aachen University
- Investigators
- Andreas Follmann, Dr., Principal investigator, RWTH Aachen University HospitalJan Wienhold, cand. med., Principal investigator, RWTH Aachen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518514
- Sponsor's protocol ID
- 19-174
- Status last verified
- Aug 2020
- First submitted
- 28 Jul 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wienhold J, Mosch L, Rossaint R, Kemper I, Derwall M, Czaplik M, Follmann A. Teleconsultation for preoperative evaluation during the coronavirus disease 2019 pandemic: A technical and medical feasibility study. Eur J Anaesthesiol. 2021 Dec 1;38(12):1284-1292. doi: 10.1097/EJA.0000000000001616.
PubMed 34669644
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedical Risk Assessment and Preoperative Evaluation for Anesthesia During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04518514
- Acronym / sponsor ID
- 19-174
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Docs in Clouds Telecare GmbH
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 19 Aug 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.
The purpose of this study is to assess the feasibility, patient satisfaction and time saving of a telemedical risk assessment and preoperative evaluation for anesthesia.
Detailed description
The preanesthesia evaluation and risk assessment is conducted by an anesthesiologist prior to elective surgery. The physician assesses the patient´s medical records and specifies the individual preoperative procedure in order to minimize the perioperative risks. The on-site meeting is often connected with extended travel time and during the COVID-19 pandemic also with an increased infection risk for the patient. This project was initiated to reduce time efforts on patient site and to reduce possible infection risks. The TAPE-software turns every patients home into a remote facility allowing the physician to conduct the preanesthesia evaluation over distance.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative evaluation and risk assessment via telemedicine | Experimental | Device: TAPE-Software |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years
- estimated ASA I/II classification based on the American Society of Anesthesiologists (ASA) classification
- elective surgery
- surgery at least 14 days in the future
- patient access to a Windows-10-based personal computer with webcam
Key exclusion criteria (3 listed)
- language or cognitive barriers (e.g. dementia, laryngectomy...)
- high risk surgeries with need of postoperative ICU stay
- acute infection with required auscultation
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 |
|---|---|---|
| TAPE-SoftwareTelemedical Risk Assessment and Preoperative Evaluation prior to anaesthesia via personal computer | Device | Preoperative evaluation and risk assessment via telemedicine |
Primary outcome
Feasibility (as defined below) of telemedical risk assessment and preoperative evaluation in anesthesiology as assessed by a questionnaire.
Time frame: 6 months
We focus on the feasibility of a telemedical risk assessment and preoperative evaluation in anesthesiology. We defined feasibility in our scenario as: * establishment of a video-audio-connection possible * complete assessment of the patients medical records possible * assessment of the individual perioperative risk possible * physician is put into the position to explain planned procedures and related risks * digital documentation possible * physician is put into the position to answer patient questions * physician can acquire all necessary information * digital signature on both sides possible Those criteria will be assessed by our questionnaires. After preanesthesia evaluation the patient as well as the physician are asked to answer our online questionnaire (two different ones).
Patient acceptance of a telemedical preanesthesia evaluation as assessed by a questionnaire.
Time frame: 6 months
After preanesthesia evaluation the patient is asked to answer our online questionnaire. The questionnaire is partly based on a previously published study (Follmann et al., Technical Support by Smart Glasses During a Mass Casualty Incident: A Randomized Controlled Simulation Trial on Technically Assisted Triage and Telemedical App Use in Disaster Medicine, J Med Internet Res 2019;21(1):e11939).
Patient satisfaction with a telemedical preanesthesia evaluation as assessed by a questionnaire.
Time frame: 6 months
We aim to investigate patient satisfaction of a telemedical risk assessment and preoperative evaluation in anesthesiology prior to elective surgery. After preanesthesia evaluation the patient is asked to answer our online questionnaire. The questionnaire is partly based on a previously published study (Follmann et al., Technical Support by Smart Glasses During a Mass Casualty Incident: A Randomized Controlled Simulation Trial on Technically Assisted Triage and Telemedical App Use in Disaster Medicine, J Med Internet Res 2019;21(1):e11939).
Time saving for the patient
Time frame: 6 months
We quantify time saving on patient site due to the fact that patients do not have to travel to the hospital anymore.
Time saving for the physician
Time frame: 6 months
On physician site we investigate possible time saving due to the implementation of the investigator's software.
Adverse events
Time frame: 6 months
Number of patients in whom telemedical preanesthesia evaluation lead to adverse events such as postponed surgery and adverse events during surgery which are caused by the preanesthesia evaluation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Derived from this study: PubMed 34669644Wienhold J, Mosch L, Rossaint R, Kemper I, Derwall M, Czaplik M, Follmann A. Teleconsultation for preoperative evaluation during the coronavirus disease 2019 pandemic: A technical and medical feasibility study. Eur J Anaesthesiol. 2021 Dec 1;38(12):1284-1292. doi: 10.1097/EJA.0000000000001616.
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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.
Andreas Follmann, Dr. principal investigator
RWTH Aachen University Hospital
Jan Wienhold, cand. med. principal investigator
RWTH Aachen University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAPE-Software in people with Patients Undergoing Elective Surgery With Anesthesia, run by RWTH Aachen University 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 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: status not confirmed, as of the sponsor's last update on 19 Aug 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?
Contact Andreas Follmann, Dr. (0049 0241 8036219, afollmann@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (as defined below) of telemedical risk assessment and preoperative evaluation in anesthesiology as assessed by a questionnaire. (time frame: 6 months). The study lists 6 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 NCT04518514, which also lists 1 linked publication.
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 19 Aug 2020.