- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06724380
Detection of Health Risk Situations in the Anesthesia Consultation.
February 10, 2025 updated by: Consorci Sanitari de l'Alt Penedès i Garraf
This study aims to estimate the proportion of patients seen in the anesthesiology consultation for planned surgery in whom a previously unknown health risk situation is detected (e.g., obesity, anemia, etc.).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
218
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Laura Mingüell, MD
- Phone Number: 0034938960025
- Email: lminguell@csapg.cat
Study Contact Backup
- Name: Noemí Casaponsa
- Phone Number: 43197 0034938960025
- Email: recerca@csapg.cat
Study Locations
-
-
Barcelona
-
Vilafranca del Penedés, Barcelona, Spain
- Recruiting
- Consorci Sanitari Alt Penedès-Garraf
-
Contact:
- Laura Mingüell, MD
- Phone Number: 0034938960025
- Email: lminguell@csapg.cat
-
Contact:
- Noemí Casaponsa
- Phone Number: 43197 0034938960025
- Email: recerca@csapg.cat
-
Contact:
- Laura Mingüell, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients evaluated in person at the preoperative anesthesia consultation for a scheduled surgery indication.
Description
Inclusion Criteria:
Men and women aged 18 to 50 years.
- Indication for elective surgery.
- In-person preoperative evaluation in the scheduled Anesthesiology consultation.
Exclusion Criteria:
- Indication for non-deferrable urgent surgery.
- Pregnant women.
- Pre-surgical visit outside the anesthesia consultation.
- Incomplete preoperative evaluation, as indicated in the final section (preoperative judgment) of the anesthesia visit report.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
unknown health risk situation
Time Frame: 1 year
|
proportion of patients with a unknown health risk situation
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 4, 2025
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
December 5, 2024
First Submitted That Met QC Criteria
December 5, 2024
First Posted (Actual)
December 9, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 10, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- CSAPG-64
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG).
Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
IPD Sharing Time Frame
After publication of main results of the study.
IPD Sharing Access Criteria
IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection.
The requirements will be directed to the IP of the study.
The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested.
Next, the IP will transfer the request to the promotor center the study for the final decision.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.