AnesthesiaNCT06228040
Is Pre-anaesthetic Teleconsultation a Safe Alternative to Traditional Pre-anaesthetic Consultation?
A study testing preanaesthetic teleconsultation and preanaesthetic classical physical consultation in people with Anesthesia, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
A pre-anaesthetic consultation is compulsory. It must be carried out at least 8 days before a scheduled medical and/or surgical operation. Its main objectives are to take the patient's history, carry out a clinical examination, select the complementary examinations that should be carried out, and inform the patient of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- preanaesthetic teleconsultation and preanaesthetic classical physical consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Jan 2024to 30 Mar 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for gastroscopy and/or colonoscopy and who have signed the consent form.
- Pre-anaesthetic consultation by telephone.
- Procedure scheduled in day hospital.
- patients having undergone gastroscopy and/or colonoscopy during the period between 01/01/2023 and 31/06/2023.
- Pre-anaesthetic consultation carried out face-to-face.
- Day hospital procedure.
- Patients eligible for teleconsultation
Who cannot join
- Participation in another clinical study within the previous month.
- Patient unable to complete the questionnaire.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Pre-anaesthetic Teleconsultation a Safe Alternative to Traditional Pre-anaesthetic
A pre-anaesthetic consultation is compulsory. It must be carried out at least 8 days before a scheduled medical and/or surgical operation. Its main objectives are to take the patient's history, carry out a clinical examination, select the complementary examinations that should be carried out, and inform the patient of the procedure and the type of anaesthetic proposed. In a world moving towards virtualisation, a number of medical specialities have opted for remote consultations, either by telephone or video-conferencing. Teleconsultation seems to offer greater satisfaction, not only for patients, but also for surgeons and anaesthetists. It is also associated with a reduction in the distance travelled by patients, costs and financial expenditure, with no increase in the rate of cancellation of surgery. For the first time at the Brussels University Hospital (Erasme), the anaesthesia and intensive care team will gradually introduce the system of pre-anaesthetic teleconsultation by telephone from October 2023.
The aim of our study is to evaluate the effectiveness of preanaesthetic teleconsultation at the Erasme HUB. In fact, it would be better to have results based on local expertise in order to give an answer on the effectiveness, safety and security of this innovative method, which will be officially implemented in October 2023.
- Conditions
- Anesthesia
- Being tested
- preanaesthetic teleconsultation, preanaesthetic classical physical consultation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preanaesthetic teleconsultationOther
Pre-anaesthetic consultation by telephone for eligible patients according to the criteria set
preanaesthetic classical physical consultationOther
Pre-anaesthetic classical consultation before teleconsultation implementation
| Study group | Role | What they receive |
|---|---|---|
| Before preanaesthetic teleconsultation implementation | Active comparator | Not described Receives: Other: preanaesthetic classical physical consultation |
| After preanaesthetic teleconsultation implementation | Experimental | Not described Receives: Other: preanaesthetic teleconsultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of Patient endangerment (0-4)
Patient endangerment : 0 = Nothing to report; 1 = Lack of information but no danger to the patient; 2 =Lack of information and reduced safety but intervention maintained; 3 = Too great a risk to the patient.
Measured: at the end of the procedure
Secondary outcomes (2)
Satisfaction scores reported on LIKERT scale (1-5)
How do you feel about the anaesthetic teleconsultation? 1 = Very satisfied; 2 = Satisfied; 3 = Neither satisfied nor dissatisfied; 4 = Not very satisfied; 5 = Not at all satisfied.
Measured: before the procedure
Pre-operative anxiety scorereported on LIKERT scale (1-5)
How would you rate your level of anxiety? 1 = Not at all anxious; 2 = Slightly anxious; 3 = Moderately anxious; 4 = Somewhat anxious; 5 = Very anxious
Measured: before the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start18 Jan 2024
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Before - After study
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Céline Boudart, Erasme University Hospital
- Investigators
- boudart céline, Principal investigator, HUB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228040
- Sponsor's protocol ID
- P2023/437
- Status last verified
- Apr 2024
- First submitted
- 9 Jan 2024
- Last updated
- 19 Apr 2024
- 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 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Pre-anaesthetic Teleconsultation a Safe Alternative to Traditional Pre-anaesthetic
- ClinicalTrials.gov ID
- NCT06228040
- Acronym / sponsor ID
- P2023/437
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 29 Jan 2024 (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.
A pre-anaesthetic consultation is compulsory. It must be carried out at least 8 days before a scheduled medical and/or surgical operation. Its main objectives are to take the patient's history, carry out a clinical examination, select the complementary examinations that should be carried out, and inform the patient of the procedure and the type of anaesthetic proposed. In a world moving towards virtualisation, a number of medical specialities have opted for remote consultations, either by telephone or video-conferencing. Teleconsultation seems to offer greater satisfaction, not only for patients, but also for surgeons and anaesthetists. It is also associated with a reduction in the distance travelled by patients, costs and financial expenditure, with no increase in the rate of cancellation of surgery. For the first time at the Brussels University Hospital (Erasme), the anaesthesia and intensive care team will gradually introduce the system of pre-anaesthetic teleconsultation by telephone from October 2023.
The aim of our study is to evaluate the effectiveness of preanaesthetic teleconsultation at the Erasme HUB. In fact, it would be better to have results based on local expertise in order to give an answer on the effectiveness, safety and security of this innovative method, which will be officially implemented in October 2023.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Before - After study
| Arm | Type | Receives |
|---|---|---|
| Before preanaesthetic teleconsultation implementation | Active comparator | Other: preanaesthetic classical physical consultation |
| After preanaesthetic teleconsultation implementation | Experimental | Other: preanaesthetic teleconsultation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients scheduled for gastroscopy and/or colonoscopy and who have signed the consent form.
- Pre-anaesthetic consultation by telephone.
- Procedure scheduled in day hospital.
- patients having undergone gastroscopy and/or colonoscopy during the period between 01/01/2023 and 31/06/2023.
- Pre-anaesthetic consultation carried out face-to-face.
Key exclusion criteria (2 listed)
- Participation in another clinical study within the previous month.
- Patient unable to complete the questionnaire.
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 |
|---|---|---|
| preanaesthetic teleconsultationPre-anaesthetic consultation by telephone for eligible patients according to the criteria set | Other | After preanaesthetic teleconsultation implementation |
| preanaesthetic classical physical consultationPre-anaesthetic classical consultation before teleconsultation implementation | Other | Before preanaesthetic teleconsultation implementation |
Primary outcome
Score of Patient endangerment (0-4)
Time frame: at the end of the procedure
Patient endangerment : 0 = Nothing to report; 1 = Lack of information but no danger to the patient; 2 =Lack of information and reduced safety but intervention maintained; 3 = Too great a risk to the patient.
2 secondary outcomes
Satisfaction scores reported on LIKERT scale (1-5)
Time frame: before the procedure
Pre-operative anxiety scorereported on LIKERT scale (1-5)
Time frame: before the procedure
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 19 Apr 2024.
- 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.
boudart céline principal investigator
HUB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preanaesthetic teleconsultation and preanaesthetic classical physical consultation in people with Anesthesia, run by Erasme University Hospital 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 7 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: finished, as of the sponsor's last update on 19 Apr 2024. 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?
Score of Patient endangerment (0-4) (time frame: at the end of the 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 19 Apr 2024.