Mobile ApplicationPreanestes@sNCT06602310
Utility of Preanestes@s2.0, a Web Based Application for Preoperative Assessment.
A study testing Web based preoperative assessment in people with Mobile Application and Preoperative Period, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 2 sites in Spain.
Trial summary
The use of web based self-assessment questionnaires as a complementary tool for conducting preoperative assessment (POA) is gaining increasing acceptance. Preanestes@s2.0 is a web based application fully developed by the investigators team which potentially allows for remote non-telephonic POA. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mobile Application, Preoperative Period, Internet-based Intervention
- What is being tested?
- Web based preoperative assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,254 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jun 2025to 20 Jul 2025
- 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
- Participants undergoing day scheduled surgery in our institutions: Hospitales Universitarios Virgen del Rocío y Virgen Macarena.
- Surgical specialities included: Urology, General Surgery, Orthopedics, Ear, nose, and throat surgery.
Who cannot join
- Urgent procedures, oncologic procedures, patients without the ability to understand informed consent.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario Virgen Macarena
Seville, 41009
Hospital Universitario Virgen Del Rocío
Seville, 41013
About this study
Official title: Evaluation of the Utility of the Preanestes@s2.0, a Web Based Application for Preoperative Assessment. Comparison of the Rate of Suboptimal Web Based Telematic Assessments Versus the Outpatient Visit.
The use of web based self-assessment questionnaires as a complementary tool for conducting preoperative assessment (POA) is gaining increasing acceptance. Preanestes@s2.0 is a web based application fully developed by the investigators team which potentially allows for remote non-telephonic POA. It has already been evaluated as a feasible tool in terms of patient acceptance and quality of the information recorded. In this prospective two-arm study, the investigators will evaluate the incidence of suboptimal POA when the participants are evaluated through Preanestes@s2.0 versus the traditional outpatient face to face visit. The investigators will consider as suboptimal any POA that potentially may generate an inadequate preparation of the patient which may affect the expected results. A total 1.127 participants will be evaluated through Preanestes@s2.0 (intervention arm) and compared to a cohort of 1.127 patients evaluated by traditional face-to-face interview (non-intervention arm). The comparison will be made by means of a propensity score matching study. Patients included in both arms of the study will be recruited throughout the same period of time.
Read the detailed description
Preoperative evaluation models that integrate the use of electronic health records and telephone or electronic questionnaires are evolving aiming to optimize the preoperative assessment process. In 2018, the investigators developed Preanestes@s, a web based application conceived to allow for remote preoperative assessment and guide patients through the preoperative period. The application includes a patient interface which offers general and individualized information on the preoperative process, with the possibility of generating a dynamic interaction between patients and medical staff. Patient interface incorporates a smart web based preoperative questionnaire (PreQuest), which once fully completed automatically classifies patients as per their American ASA grade (from the American Society of Anesthesia Physical Status Classification), and suggests the convenience of a face-to-face visit (f-visit) versus a virtual non-face-to-face non-telephonic visit (v-visit) according to the assigned ASA grade (patients with ASA grade≥3 are systematically recommended for f-visit) and the presence of predefined comorbidities or physical conditions not necessarily related to a specific ASA grade (i.e., current or persistent cough or dyspnea). Both virtual and f-visit are performed by an anesthesiologist. Preanestes@s also determines the preoperative tests that should be conducted according to the patient's condition and offers individualized health advice and recommendations on treatment, with the option of electronically signing an experimental model of electronic informed consent.
In its original version, Preanestes@s has been evaluated both in terms of user acceptance and usability, as well as in terms of the quality of information recording, this last by means of a paired study which compared the information recorded through PreQuest with that recorded by the anesthesiologist when performing the v-visit and the f-visit. The results have been favorable to the model, both in terms of user acceptance and of the quality of the information recording.
On april 2021 the investigators launched a prospective study to evaluate the feasibility and utility of the model, this estimated by comparing the rate of suboptimal preoperative studies carried out using the application versus the traditional outpatient f-visit (Evaluation of the Utility of Preanestes@s, a Web Based Application for Preoperative Assessment; NCT04787783). Unfortunately, the study recruitment rate has been lower than expected, partly due to the difficulties derived from the limited collaboration of the surgeons, the actors initially proposed to lead the recruiting process (recruitment should preferably take place at the time of the surgical indication at the surgeon´s office). Once the investigators detected the difficulties in recruiting by surgeons, they considered filling this shortage through the figure of a recruiting agent, but the investigators were forced to discontinue this task due to lack of funding, what finally led them to seek alternatives to improve the effectiveness and efficiency of the model. From that moment on, the investigators began to work with the objective of achieving automatic patient recruitment. This is how the Preanestes@s2.0 version came about.
Preanestes@s2.0 incorporates a new automatic recruitment interface, so that information that previously had to be entered by the surgeon or, in its defect, by a recruiting agent, is now filled in automatically. Similarly, the new patient management interface has also been improved in automatism and simplified, so that the information that previously had to be managed by the administrative staff is now managed automatically.
On the other hand, the f-visit has been replaced by a telephone visit (t-visit), so that the options available in the model would be the v-visit (non face-to-face non-telephone) and the t-visit (non face-to-face but telephone), regardless of the fact that the anesthesiologist evaluating each case may request a f-visit on demand for specific cases.
Preanestes@s2.0 also automates the patient appointment process, thus reducing the administrative workload and improving the efficiency of the model.
Finally, Preanestes@s2.0 also improves its capabilities when communicating with the patient, with the incorporation, among others, of WhatsApp messaging.
Assuming the improvements of the model and taking into account that they represent a relevant modification to the conditions of the original study, the investigators designed a new prospective work aimed at comparing the rate of adequate preoperative assessments using the Preanestesas2.0 application versus the traditional face-to-face model.
This study (Internal code SICEIA-2024-001682) has been approved by the local Ethics Committee -Comité de Ética e Investigación de los Hospitales Universitarios Virgen Macarena y Virgen del Rocío-and signed by its Secretary José Carlos García Pérez, date 26.07.2024.
In this study, the objective of the investigators is to assess whether the use of a web based application for the preoperative assessment allows an adequate completion of the preoperative process when compared to traditional face-to-face outpatient interview. The quality of the information recorded by this web based application has been previously tested by the investigators showing promising results in terms of security and accuracy.
The investigators have designed a prospective two-arm study to compare the performance of the two modalities of preoperative assessment: web based versus face to face outpatient visit.
The investigators will base their evaluation of performance on previously published criteria: the Andalusian Regional Government Health Council defines a suboptimal preoperative assessment (SOPA) as one that potentially generates an inadequate preparation of the patient that may affect the expected results. Specific criteria defining SOPA are detailed in the Outcomes Measures section of the present document.
A total 1.127 participants will be evaluated through Preanestes@s2.0 (Intervention arm) and compared to a cohort of 1.127 patients evaluated by traditional face-to-face interview (Non-intervention arm).
Allocation of participants to Intervention arm will be consecutive and based on daily distribution of the clinics: Orthopedics, General Surgery and Urology. Participants in the Non-intervention group will be recruited ex-post, using the propensity score methodology among patients assessed by the traditional face to face format throughout the study period.Written informed consent will be obtained of all participants in the Intervention group prior to their recruitment.
Statistical analysis Data collection and subsequent analysis will be performed by the investigators team. Qualitative variables will be represented through the absolute and marginal frequencies. The investigators will analyze the incidence of SOPA in both groups, using Chi square to study the difference between the proportions in the case of normal distribution, or, failing that, the Mann-Whitney U. In the same way, the investigators will study the differences for each of the defining criteria of SOPA.
Sample Siz: following the model of Kinley et al in the study comparing the quality of the pre-anesthesia record carried out by anesthesia trainees versus trained nurses, the investigators will use the variable Incomplete studies that could have affected perioperative management for the calculation of the sample size. This variable would be equivalent to the variable SOPA in present work. Based on Kinley data, the investigators will use an incomplete study rate of 15%, a figure that coincides with the standard Inadequate assessment in the Guide for the Perioperative Process published by the Andalusian Regional Government Health Council, which establishes a maximum; acceptable; rate of inadequate completion of the preoperative protocols in 15%. In this study of equivalence between the two formats, the investigators will assume equivalence if a maximum difference of 25% between both formats is observed, which represents a differential of 3.75% over the initial 15%. Thus, for a two-sided calculation and assuming an alpha error of 0.05 and a beta error of 0.2 (80% power), it would be necessary to include 1,127 participants per group.
- Conditions
- Mobile Application, Preoperative Period, Internet-based Intervention, Surgical Procedures, Elective, Assessment Evaluation
- Being tested
- Web based preoperative assessment
- Keywords
- Electronic Health Records, Health Impact Assessment, Patient Health Questionnaire, Preoperative Period
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web based preoperative assessmentOther
Preoperative assessment conducted through a web based application. Telematic non-face-to-face preoperative assessment.
| Study group | Role | What they receive |
|---|---|---|
| Preanestes@s2.0: web-based non-face-to-face preoperative assessment. Telematic group. | Experimental | Participants will be leaded through preoperative period on a web based application. Participants will be addressed to either virtual or telephone POA on the basis of the information registered in the web based preoperative questionnaire that the application incorporates. Virtual assessment will be performed by evaluating both the filled web based questionnaire together with participants´ electronic medical records. Telephone assessment will also incorporate a telephone call for further clarifications. Receives: Other: Web based preoperative assessment |
| Traditional face-to-face preoperative assessment | No intervention | Participants will be leaded through preoperative period following traditional institutional standards of care. Face to face assessment will be performed in the traditional way by means of an interview with the participant together with the consultation of participant´s previous electronic records. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suboptimal preoperative assessments (SOPA).
Dichotomous (present/absent) composite variable comprising any of the following:
- Lack of relevant information in the preoperative assessment that conducts to: - Inadequate conciliation of chronic medication - Inadequate preoperative fasting - Inadequate register of clinical or functional conditions that may cause delayed intervention the day of surgery (presence of uncontrolled chronic diseases, presence of impaired functional status undetected in the preoperative assessment, etcetera.
- Lack of complementary tests indicated according to preoperative protocol
- Presence of not indicated complementary tests according to preoperative protocol
- Lack of properly filled informed consent
- Cancellation of the intervention due to inadequate preoperative preparation (attributable to mismanagement of preoperative information)
Measured: From the day of intervention up to 7 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jun 2025
- Primary completion1 Jul 2025
- Study completion20 Jul 2025
Why it stopped: The study has been terminated due to technical limitations in the institutional IT system, which cannot support the maintenance and integration of the application. Consequently, no further participant recruitment will be conducted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Mobile ApplicationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602310
- Sponsor's protocol ID
- PREANEST.2.0
- Acronym
- Preanestes@s
- Status last verified
- Jul 2025
- First submitted
- 16 Sep 2024
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Goodhart IM, Andrzejowski JC, Jones GL, Berthoud M, Dennis A, Mills GH, Radley SC. Patient-completed, preoperative web-based anaesthetic assessment questionnaire (electronic Personal Assessment Questionnaire PreOperative): Development and validation. Eur J Anaesthesiol. 2017 Apr;34(4):221-228. doi: 10.1097/EJA.0000000000000545.
PubMed 27798453Arias A, Benitez S, Canosa D, Borbolla D, Staccia G, Plazzotta F, Casais M, Michelangelo H, Luna D, Bernaldo de Quiros FG. Computerization of a preanesthetic evaluation and user satisfaction evaluation. Stud Health Technol Inform. 2010;160(Pt 2):1197-201.
PubMed 20841873Zaballos M, Lopez-Alvarez S, Argente P, Lopez A; Grupo de Trabajo de Pruebas Preoperatorias. Preoperative tests recommendations in adult patients for ambulatory surgery. Rev Esp Anestesiol Reanim. 2015 Jan;62(1):29-41. doi: 10.1016/j.redar.2014.07.007. Epub 2014 Aug 18. English, Spanish.
PubMed 25146773De Hert S, Staender S, Fritsch G, Hinkelbein J, Afshari A, Bettelli G, Bock M, Chew MS, Coburn M, De Robertis E, Drinhaus H, Feldheiser A, Geldner G, Lahner D, Macas A, Neuhaus C, Rauch S, Santos-Ampuero MA, Solca M, Tanha N, Traskaite V, Wagner G, Wappler F. Pre-operative evaluation of adults undergoing elective noncardiac surgery: Updated guideline from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2018 Jun;35(6):407-465. doi: 10.1097/EJA.0000000000000817.
PubMed 29708905Kinley H, Czoski-Murray C, George S, McCabe C, Primrose J, Reilly C, Wood R, Nicolson P, Healy C, Read S, Norman J, Janke E, Alhameed H, Fernandes N, Thomas E. Effectiveness of appropriately trained nurses in preoperative assessment: randomised controlled equivalence/non-inferiority trial. BMJ. 2002 Dec 7;325(7376):1323. doi: 10.1136/bmj.325.7376.1323.
PubMed 12468478Conde JM, Moreno-Conde A, Salas-Fernandez S, Parra-Calderon CL. ITCBio, a Clinical and Translational Research Platform. AMIA Annu Symp Proc. 2020 Mar 4;2019:673-680. eCollection 2019.
PubMed 32308862Lozada MJ, Nguyen JT, Abouleish A, Prough D, Przkora R. Patient preference for the pre-anesthesia evaluation: Telephone versus in-office assessment. J Clin Anesth. 2016 Jun;31:145-8. doi: 10.1016/j.jclinane.2015.12.040. Epub 2016 Apr 15.
PubMed 27185698Law TT, Suen DT, Tam YF, Cho SY, Chung HP, Kwong A, Yuen WK. Telephone pre-anaesthesia assessment for ambulatory breast surgery. Hong Kong Med J. 2009 Jun;15(3):179-82.
PubMed 19494372Ludbrook G, Seglenieks R, Osborn S, Grant C. A call centre and extended checklist for pre-screening elective surgical patients - a pilot study. BMC Anesthesiol. 2015 May 19;15:77. doi: 10.1186/s12871-015-0057-1.
PubMed 25985775Blanco Vargas D, Faura Messa A, Izquierdo Tugas E, Santa-Olalla Bergua M, Noguera Sopena MM, Manoso Noriego M. [Online versus non-standard face to face preoperative assessment: cost effectiveness]. Rev Esp Anestesiol Reanim. 2012 Aug-Sep;59(7):350-6. doi: 10.1016/j.redar.2012.05.039. Epub 2012 Jul 10. Spanish.
PubMed 22784647Applegate 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 23384334de la Matta M, Alonso-Gonzalez M, Moreno-Conde J, Salas-Fernandez S, Lopez-Romero JL; Preanestesas study investigators. Development and patient acceptance of Preanestes@s, a web-based application and electronic questionnaire for preoperative assessment. A prospective cohort study. Rev Esp Anestesiol Reanim (Engl Ed). 2022 Aug-Sep;69(7):383-392. doi: 10.1016/j.redare.2022.01.002. Epub 2022 Jul 20.
PubMed 35871145de la Matta M, Alonso-Gonzalez M, Garcia-Santigosa M, Arance-Garcia M, Sanchez-Pena J, Castro-Linan LM, Lopez-Romero JL. Accuracy and Comprehensiveness in Recording Information of a Web-Based Application for Preoperative Assessment: A Prospective Observational Study. J Perianesth Nurs. 2023 Jun;38(3):440-447. doi: 10.1016/j.jopan.2022.08.004. Epub 2022 Dec 9.
PubMed 36509667
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Utility of the Preanestes@s2.0, a Web Based Application for Preoperative Assessment. Comparison of the Rate of Suboptimal Web Based Telematic Assessments Versus the Outpatient Visit.
- ClinicalTrials.gov ID
- NCT06602310
- Acronym / sponsor ID
- Preanestes@s / PREANEST.2.0
- Conditions
- Mobile Application, Preoperative Period, Internet-based Intervention, Surgical Procedures, Elective, Assessment Evaluation
- Keywords
- Electronic Health Records, Health Impact Assessment, Patient Health Questionnaire, Preoperative Period
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has been terminated due to technical limitations in the institutional IT system, which cannot support the maintenance and integration of the application. Consequently, no further participant recruitment will be conducted.
- Enrolment
- 2,254 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 19 Sep 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.
The use of web based self-assessment questionnaires as a complementary tool for conducting preoperative assessment (POA) is gaining increasing acceptance. Preanestes@s2.0 is a web based application fully developed by the investigators team which potentially allows for remote non-telephonic POA. It has already been evaluated as a feasible tool in terms of patient acceptance and quality of the information recorded. In this prospective two-arm study, the investigators will evaluate the incidence of suboptimal POA when the participants are evaluated through Preanestes@s2.0 versus the traditional outpatient face to face visit. The investigators will consider as suboptimal any POA that potentially may generate an inadequate preparation of the patient which may affect the expected results. A total 1.127 participants will be evaluated through Preanestes@s2.0 (intervention arm) and compared to a cohort of 1.127 patients evaluated by traditional face-to-face interview (non-intervention arm). The comparison will be made by means of a propensity score matching study. Patients included in both arms of the study will be recruited throughout the same period of time.
Detailed description
Preoperative evaluation models that integrate the use of electronic health records and telephone or electronic questionnaires are evolving aiming to optimize the preoperative assessment process. In 2018, the investigators developed Preanestes@s, a web based application conceived to allow for remote preoperative assessment and guide patients through the preoperative period. The application includes a patient interface which offers general and individualized information on the preoperative process, with the possibility of generating a dynamic interaction between patients and medical staff. Patient interface incorporates a smart web based preoperative questionnaire (PreQuest), which once fully completed automatically classifies patients as per their American ASA grade (from the American Society of Anesthesia Physical Status Classification), and suggests the convenience of a face-to-face visit (f-visit) versus a virtual non-face-to-face non-telephonic visit (v-visit) according to the assigned ASA grade (patients with ASA grade≥3 are systematically recommended for f-visit) and the presence of predefined comorbidities or physical conditions not necessarily related to a specific ASA grade (i.e., current or persistent cough or dyspnea). Both virtual and f-visit are performed by an anesthesiologist. Preanestes@s also determines the preoperative tests that should be conducted according to the patient's condition and offers individualized health advice and recommendations on treatment, with the option of electronically signing an experimental model of electronic informed consent.
In its original version, Preanestes@s has been evaluated both in terms of user acceptance and usability, as well as in terms of the quality of information recording, this last by means of a paired study which compared the information recorded through PreQuest with that recorded by the anesthesiologist when performing the v-visit and the f-visit. The results have been favorable to the model, both in terms of user acceptance and of the quality of the information recording.
On april 2021 the investigators launched a prospective study to evaluate the feasibility and utility of the model, this estimated by comparing the rate of suboptimal preoperative studies carried out using the application versus the traditional outpatient f-visit (Evaluation of the Utility of Preanestes@s, a Web Based Application for Preoperative Assessment; NCT04787783). Unfortunately, the study recruitment rate has been lower than expected, partly due to the difficulties derived from the limited collaboration of the surgeons, the actors initially proposed to lead the recruiting process (recruitment should preferably take place at the time of the surgical indication at the surgeon´s office). Once the investigators detected the difficulties in recruiting by surgeons, they considered filling this shortage through the figure of a recruiting agent, but the investigators were forced to discontinue this task due to lack of funding, what finally led them to seek alternatives to improve the effectiveness and efficiency of the model. From that moment on, the investigators began to work with the objective of achieving automatic patient recruitment. This is how the Preanestes@s2.0 version came about.
Preanestes@s2.0 incorporates a new automatic recruitment interface, so that information that previously had to be entered by the surgeon or, in its defect, by a recruiting agent, is now filled in automatically. Similarly, the new patient management interface has also been improved in automatism and simplified, so that the information that previously had to be managed by the administrative staff is now managed automatically.
On the other hand, the f-visit has been replaced by a telephone visit (t-visit), so that the options available in the model would be the v-visit (non face-to-face non-telephone) and the t-visit (non face-to-face but telephone), regardless of the fact that the anesthesiologist evaluating each case may request a f-visit on demand for specific cases.
Preanestes@s2.0 also automates the patient appointment process, thus reducing the administrative workload and improving the efficiency of the model.
Finally, Preanestes@s2.0 also improves its capabilities when communicating with the patient, with the incorporation, among others, of WhatsApp messaging.
Assuming the improvements of the model and taking into account that they represent a relevant modification to the conditions of the original study, the investigators designed a new prospective work aimed at comparing the rate of adequate preoperative assessments using the Preanestesas2.0 application versus the traditional face-to-face model.
This study (Internal code SICEIA-2024-001682) has been approved by the local Ethics Committee -Comité de Ética e Investigación de los Hospitales Universitarios Virgen Macarena y Virgen del Rocío-and signed by its Secretary José Carlos García Pérez, date 26.07.2024.
In this study, the objective of the investigators is to assess whether the use of a web based application for the preoperative assessment allows an adequate completion of the preoperative process when compared to traditional face-to-face outpatient interview. The quality of the information recorded by this web based application has been previously tested by the investigators showing promising results in terms of security and accuracy.
The investigators have designed a prospective two-arm study to compare the performance of the two modalities of preoperative assessment: web based versus face to face outpatient visit.
The investigators will base their evaluation of performance on previously published criteria: the Andalusian Regional Government Health Council defines a suboptimal preoperative assessment (SOPA) as one that potentially generates an inadequate preparation of the patient that may affect the expected results. Specific criteria defining SOPA are detailed in the Outcomes Measures section of the present document.
A total 1.127 participants will be evaluated through Preanestes@s2.0 (Intervention arm) and compared to a cohort of 1.127 patients evaluated by traditional face-to-face interview (Non-intervention arm).
Allocation of participants to Intervention arm will be consecutive and based on daily distribution of the clinics: Orthopedics, General Surgery and Urology. Participants in the Non-intervention group will be recruited ex-post, using the propensity score methodology among patients assessed by the traditional face to face format throughout the study period.Written informed consent will be obtained of all participants in the Intervention group prior to their recruitment.
Statistical analysis Data collection and subsequent analysis will be performed by the investigators team. Qualitative variables will be represented through the absolute and marginal frequencies. The investigators will analyze the incidence of SOPA in both groups, using Chi square to study the difference between the proportions in the case of normal distribution, or, failing that, the Mann-Whitney U. In the same way, the investigators will study the differences for each of the defining criteria of SOPA.
Sample Siz: following the model of Kinley et al in the study comparing the quality of the pre-anesthesia record carried out by anesthesia trainees versus trained nurses, the investigators will use the variable Incomplete studies that could have affected perioperative management for the calculation of the sample size. This variable would be equivalent to the variable SOPA in present work. Based on Kinley data, the investigators will use an incomplete study rate of 15%, a figure that coincides with the standard Inadequate assessment in the Guide for the Perioperative Process published by the Andalusian Regional Government Health Council, which establishes a maximum; acceptable; rate of inadequate completion of the preoperative protocols in 15%. In this study of equivalence between the two formats, the investigators will assume equivalence if a maximum difference of 25% between both formats is observed, which represents a differential of 3.75% over the initial 15%. Thus, for a two-sided calculation and assuming an alpha error of 0.05 and a beta error of 0.2 (80% power), it would be necessary to include 1,127 participants per group.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preanestes@s2.0: web-based non-face-to-face preoperative assessment. Telematic group. | Experimental | Other: Web based preoperative assessmentParticipants will be leaded through preoperative period on a web based application. Participants will be addressed to either virtual or telephone POA on the basis of the information registered in the web based preoperative questionnaire that the application incorporates. Virtual assessment will be performed by evaluating both the filled web based questionnaire together with participants´ electronic medical records. Telephone assessment will also incorporate a telephone call for further clarifications. |
| Traditional face-to-face preoperative assessment | No intervention | –Participants will be leaded through preoperative period following traditional institutional standards of care. Face to face assessment will be performed in the traditional way by means of an interview with the participant together with the consultation of participant´s previous electronic records. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants undergoing day scheduled surgery in our institutions: Hospitales Universitarios Virgen del Rocío y Virgen Macarena.
- Surgical specialities included: Urology, General Surgery, Orthopedics, Ear, nose, and throat surgery.
Key exclusion criteria (1 listed)
- Urgent procedures, oncologic procedures, patients without the ability to understand informed consent.
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 |
|---|---|---|
| Web based preoperative assessmentPreoperative assessment conducted through a web based application. Telematic non-face-to-face preoperative assessment. | Other | Preanestes@s2.0: web-based non-face-to-face preoperative assessment. Telematic group. |
Primary outcome
Suboptimal preoperative assessments (SOPA).
Time frame: From the day of intervention up to 7 days after intervention
Dichotomous (present/absent) composite variable comprising any of the following: 1. Lack of relevant information in the preoperative assessment that conducts to: - Inadequate conciliation of chronic medication - Inadequate preoperative fasting - Inadequate register of clinical or functional conditions that may cause delayed intervention the day of surgery (presence of uncontrolled chronic diseases, presence of impaired functional status undetected in the preoperative assessment, etcetera. 2. Lack of complementary tests indicated according to preoperative protocol 3. Presence of not indicated complementary tests according to preoperative protocol 4. Lack of properly filled informed consent 5. Cancellation of the intervention due to inadequate preoperative preparation (attributable to mismanagement of preoperative information)
Results and safety
The study was stopped early (reason given: The study has been terminated due to technical limitations in the institutional IT system, which cannot support the maintenance and integration of the application. Consequently, no further participant recruitment will be conducted.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Results publication: PubMed 27798453Goodhart IM, Andrzejowski JC, Jones GL, Berthoud M, Dennis A, Mills GH, Radley SC. Patient-completed, preoperative web-based anaesthetic assessment questionnaire (electronic Personal Assessment Questionnaire PreOperative): Development and validation. Eur J Anaesthesiol. 2017 Apr;34(4):221-228. doi: 10.1097/EJA.0000000000000545.
- Results publication: PubMed 20841873Arias A, Benitez S, Canosa D, Borbolla D, Staccia G, Plazzotta F, Casais M, Michelangelo H, Luna D, Bernaldo de Quiros FG. Computerization of a preanesthetic evaluation and user satisfaction evaluation. Stud Health Technol Inform. 2010;160(Pt 2):1197-201.
- Results publication: PubMed 25146773Zaballos M, Lopez-Alvarez S, Argente P, Lopez A; Grupo de Trabajo de Pruebas Preoperatorias. Preoperative tests recommendations in adult patients for ambulatory surgery. Rev Esp Anestesiol Reanim. 2015 Jan;62(1):29-41. doi: 10.1016/j.redar.2014.07.007. Epub 2014 Aug 18. English, Spanish.
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- Results publication: PubMed 12468478Kinley H, Czoski-Murray C, George S, McCabe C, Primrose J, Reilly C, Wood R, Nicolson P, Healy C, Read S, Norman J, Janke E, Alhameed H, Fernandes N, Thomas E. Effectiveness of appropriately trained nurses in preoperative assessment: randomised controlled equivalence/non-inferiority trial. BMJ. 2002 Dec 7;325(7376):1323. doi: 10.1136/bmj.325.7376.1323.
- Results publication: PubMed 32308862Conde JM, Moreno-Conde A, Salas-Fernandez S, Parra-Calderon CL. ITCBio, a Clinical and Translational Research Platform. AMIA Annu Symp Proc. 2020 Mar 4;2019:673-680. eCollection 2019.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web based preoperative assessment in people with Mobile Application and Preoperative Period, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 2 sites in Spain.
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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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 was stopped early (reason given: The study has been terminated due to technical limitations in the institutional IT system, which cannot support the maintenance and integration of the application. Consequently, no further participant recruitment will be conducted.). 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?
Suboptimal preoperative assessments (SOPA). (time frame: From the day of intervention up to 7 days after intervention). 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 NCT06602310, which also lists 13 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 23 Jul 2025.