Outpatient SurgeryANESTHADOMNCT04028622
Validation of Telemedicine Pre-anesthesia Consultation in Low-risk Anesthetic Patients Undergoing Ambulatory Surgery
A study testing TCAD (telemedicine anesthesia consultation) in people with Outpatient Surgery and Telemedicine, run by University Hospital, Grenoble.
Trial summary
The purpose of this study is to validate the teleconsultation of anesthesia in anesthetic low risk patients and undergoing outpatient surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Outpatient Surgery, Telemedicine
- What is being tested?
- TCAD (telemedicine anesthesia consultation)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for ambulatory surgery with anesthesia procedures
- Patients with American Society of Anesthesiologists score 1 or 2.
- Patients with visual and auditory acuity, language proficiency.
- Non-urgent surgery
- Affiliation to the French Social Security
Who cannot join
- patient with American Society of Anesthesiologists score 2 and complex treatments
- Complex surgical procedure
- Patient taking anticoagulant and / or antiplatelet treatments
- Patient having a serious problem during a previous surgery
- Pregnant woman
- Patient under guardianship or deprivation of liberty by judicial decision.
About this study
The purpose of this study is to validate the teleconsultation of anesthesia in anesthetic low risk patients and undergoing outpatient surgery.
Read the detailed description
Anesthesia consultation is a necessary and obligatory step in the process of anesthesia. Telemedicine anesthesia consultation (TCAD) experiments have been successfully conducted in the United States, demonstrating the technical feasibility and medical relevance of the approach. In partnership with the Rhône-Alpes Regional Health Agency, an Telemedicine anesthesia consultation will be set up at the University Hospital Grenoble for low-risk anesthetic and surgical patients via a telemedicine platform accessible to patients' homes. Avoiding transport, unclog consultations in hospitals, and avoiding absences from work for traditional consultations are some of the advantages of this new method of consultation. This project involves assessing the feasibility, safety, and costs associated with home anesthesia teleconsultation for patients requiring outpatient surgery.
- Conditions
- Outpatient Surgery, Telemedicine
- Being tested
- TCAD (telemedicine anesthesia consultation)
- Keywords
- ambulatory, anesthesia, consultation, telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCAD (telemedicine anesthesia consultation)Other
Patients in the TCAD (telemedicine anesthesia consultation) group, arrange their bookings on a website and realise their anesthesia consultation from a platform from home
| Study group | Role | What they receive |
|---|---|---|
| TCAD (telemedicine anesthesia consultation) | Experimental | Patients having a telemedicine anesthesia consultation Receives: Other: TCAD (telemedicine anesthesia consultation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of anesthesia teleconsultation in low-risk anesthetic patients undergoing outpatient surgery
Patients rate with performed surgery following a successful telemedicine anesthesia consultation without cancellation or postponement of surgery
Measured: 24 hours post surgery
Secondary outcomes (9)
Anesthesia teleconsultation failure rate for technical reasons
Rate of patients who did not benefit from anesthesia teleconsultation for technical reasons
Measured: up to 1 hour post anesthesia teleconsultation outset
Cancellation or postponement surgery rate
Patients rate
Measured: 24 hours post surgery
Patient rate, seen in teleconsultation, secondarily oriented towards a conventional consultation
Patients rate
Measured: 24 hours post surgery
Extension of the ambulatory stay rate
Patients rate
Measured: 24 hours post surgery
Readmitted patients rate
Rate of readmitted patients related with surgery and assigned to the teleconsultation
Measured: 24 hours post surgery
Patient satisfaction with anesthesia teleconsultation
Global satisfaction level (regarding the sound and picture quality, respect of confidentiality and privacy, recommend or choose teleconsultation for the next anesthesia consultation) using Numerical Rating Scale from 0 to 10, 0 : extremely unsatisfied, 10= extremely satisfied.
Measured: at 7 days post hospital discharge
Physician satisfaction with anesthesia teleconsultation
Global satisfaction level (regarding the sound and picture quality, respect of confidentiality and privacy, clinical observations collection quality, recommend teleconsultation for the next anesthesia consultation) using Numerical Rating Scale from 0 to 10, 0 : extremely unsatisfied, 10= extremely satisfied.
Measured: up to 1 hour post anesthesia teleconsultation outset
Cost of transportation from home to hospital
Cost ( euros)
Measured: at 7 days post hospital discharge
Rate of transportation carbon footprint saved using anesthesia teleconsultation
co2 equivalent
Measured: at 7 days post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study startMar 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionMay 2021 (estimated)
Why it stopped: The insufficient development of connection networks limit the teleconsultation deployment in the Grenoble metropolitan area
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Outpatient SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Agence Régionale de Santé Rhône-Alpes
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028622
- Sponsor's protocol ID
- 38RC17.217
- Acronym
- ANESTHADOM
- Status last verified
- Mar 2020
- First submitted
- 18 Mar 2019
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Applegate RL 2nd, Gildea B, Patchin R, Rook JL, Wolford B, Nyirady J, Dawes TA, Faltys J, Ramsingh DS, Stier G. Telemedicine pre-anesthesia evaluation: a randomized pilot trial. Telemed J E Health. 2013 Mar;19(3):211-6. doi: 10.1089/tmj.2012.0132. Epub 2013 Feb 5.
PubMed 23384334Charles BL. Telemedicine can lower costs and improve access. Healthc Financ Manage. 2000 Apr;54(4):66-9.
PubMed 10915354Dilisio RP, Dilisio AJ, Weiner MM. Preoperative virtual screening examination of the airway. J Clin Anesth. 2014 Jun;26(4):315-7. doi: 10.1016/j.jclinane.2013.12.010. Epub 2014 Jun 8.
PubMed 24916897Galvez JA, Rehman MA. Telemedicine in anesthesia: an update. Curr Opin Anaesthesiol. 2011 Aug;24(4):459-62. doi: 10.1097/ACO.0b013e328348717b.
PubMed 21659874Huston JL, Burton DC. Patient satisfaction with multispecialty interactive teleconsultations. J Telemed Telecare. 1997;3(4):205-8. doi: 10.1258/1357633971931174.
PubMed 9614735Wade VA, Karnon J, Elshaug AG, Hiller JE. A systematic review of economic analyses of telehealth services using real time video communication. BMC Health Serv Res. 2010 Aug 10;10:233. doi: 10.1186/1472-6963-10-233.
PubMed 20696073Wong DT, Kamming D, Salenieks ME, Go K, Kohm C, Chung F. Preadmission anesthesia consultation using telemedicine technology: a pilot study. Anesthesiology. 2004 Jun;100(6):1605-7. doi: 10.1097/00000542-200406000-00038. No abstract available.
PubMed 15166585
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Telemedicine Pre-anesthesia Consultation in Low-risk Anesthetic Patients Undergoing Ambulatory Surgery
- ClinicalTrials.gov ID
- NCT04028622
- Acronym / sponsor ID
- ANESTHADOM / 38RC17.217
- Conditions
- Outpatient Surgery, Telemedicine
- Keywords
- ambulatory, anesthesia, consultation, telemedicine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The insufficient development of connection networks limit the teleconsultation deployment in the Grenoble metropolitan area
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Agence Régionale de Santé Rhône-Alpes
- Study start
- Mar 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 22 Jul 2019 (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 validate the teleconsultation of anesthesia in anesthetic low risk patients and undergoing outpatient surgery.
Detailed description
Anesthesia consultation is a necessary and obligatory step in the process of anesthesia. Telemedicine anesthesia consultation (TCAD) experiments have been successfully conducted in the United States, demonstrating the technical feasibility and medical relevance of the approach. In partnership with the Rhône-Alpes Regional Health Agency, an Telemedicine anesthesia consultation will be set up at the University Hospital Grenoble for low-risk anesthetic and surgical patients via a telemedicine platform accessible to patients' homes. Avoiding transport, unclog consultations in hospitals, and avoiding absences from work for traditional consultations are some of the advantages of this new method of consultation. This project involves assessing the feasibility, safety, and costs associated with home anesthesia teleconsultation for patients requiring outpatient surgery.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TCAD (telemedicine anesthesia consultation) | Experimental | Other: TCAD (telemedicine anesthesia consultation)Patients having a telemedicine anesthesia consultation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients scheduled for ambulatory surgery with anesthesia procedures
- Patients with American Society of Anesthesiologists score 1 or 2.
- Patients with visual and auditory acuity, language proficiency.
- Non-urgent surgery
- Affiliation to the French Social Security
Key exclusion criteria (6 listed)
- patient with American Society of Anesthesiologists score 2 and complex treatments
- Complex surgical procedure
- Patient taking anticoagulant and / or antiplatelet treatments
- Patient having a serious problem during a previous surgery
- Pregnant woman
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 |
|---|---|---|
| TCAD (telemedicine anesthesia consultation)Patients in the TCAD (telemedicine anesthesia consultation) group, arrange their bookings on a website and realise their anesthesia consultation from a platform from home | Other | TCAD (telemedicine anesthesia consultation) |
Primary outcome
Validation of anesthesia teleconsultation in low-risk anesthetic patients undergoing outpatient surgery
Time frame: 24 hours post surgery
Patients rate with performed surgery following a successful telemedicine anesthesia consultation without cancellation or postponement of surgery
9 secondary outcomes
Anesthesia teleconsultation failure rate for technical reasons
Time frame: up to 1 hour post anesthesia teleconsultation outset
Cancellation or postponement surgery rate
Time frame: 24 hours post surgery
Patient rate, seen in teleconsultation, secondarily oriented towards a conventional consultation
Time frame: 24 hours post surgery
Extension of the ambulatory stay rate
Time frame: 24 hours post surgery
Readmitted patients rate
Time frame: 24 hours post surgery
Patient satisfaction with anesthesia teleconsultation
Time frame: at 7 days post hospital discharge
Physician satisfaction with anesthesia teleconsultation
Time frame: up to 1 hour post anesthesia teleconsultation outset
Cost of transportation from home to hospital
Time frame: at 7 days post hospital discharge
Rate of transportation carbon footprint saved using anesthesia teleconsultation
Time frame: at 7 days post hospital discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Background: PubMed 23384334Applegate RL 2nd, Gildea B, Patchin R, Rook JL, Wolford B, Nyirady J, Dawes TA, Faltys J, Ramsingh DS, Stier G. Telemedicine pre-anesthesia evaluation: a randomized pilot trial. Telemed J E Health. 2013 Mar;19(3):211-6. doi: 10.1089/tmj.2012.0132. Epub 2013 Feb 5.
- Background: PubMed 10915354Charles BL. Telemedicine can lower costs and improve access. Healthc Financ Manage. 2000 Apr;54(4):66-9.
- Background: PubMed 24916897Dilisio RP, Dilisio AJ, Weiner MM. Preoperative virtual screening examination of the airway. J Clin Anesth. 2014 Jun;26(4):315-7. doi: 10.1016/j.jclinane.2013.12.010. Epub 2014 Jun 8.
- Background: PubMed 21659874Galvez JA, Rehman MA. Telemedicine in anesthesia: an update. Curr Opin Anaesthesiol. 2011 Aug;24(4):459-62. doi: 10.1097/ACO.0b013e328348717b.
- Background: PubMed 9614735Huston JL, Burton DC. Patient satisfaction with multispecialty interactive teleconsultations. J Telemed Telecare. 1997;3(4):205-8. doi: 10.1258/1357633971931174.
- Background: PubMed 20696073Wade VA, Karnon J, Elshaug AG, Hiller JE. A systematic review of economic analyses of telehealth services using real time video communication. BMC Health Serv Res. 2010 Aug 10;10:233. doi: 10.1186/1472-6963-10-233.
- Background: PubMed 15166585Wong DT, Kamming D, Salenieks ME, Go K, Kohm C, Chung F. Preadmission anesthesia consultation using telemedicine technology: a pilot study. Anesthesiology. 2004 Jun;100(6):1605-7. doi: 10.1097/00000542-200406000-00038. No abstract available.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing TCAD (telemedicine anesthesia consultation) in people with Outpatient Surgery and Telemedicine, run by University Hospital, Grenoble.
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 6 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: withdrawn, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Validation of anesthesia teleconsultation in low-risk anesthetic patients undergoing outpatient surgery (time frame: 24 hours post surgery). 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 NCT04028622, which also lists 7 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 31 Mar 2020.