- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06693869
The Risk of Surgical Cancellation in Adult Patients Assessed by Telephone Versus In-person for Scheduled Non-cardiac Elective Surgery.
Telemedicine has been regulated in Colombia since 2006, with applications in anesthesia being explored since 2004 to improve accessibility and reduce costs. Although Decree 538 of 2020 expanded telemedicine's medical applications, challenges such as connectivity issues and training needs remain. Telemedicine has shown promise in rural areas of Colombia, particularly for managing chronic diseases. However, further evidence is needed regarding the effectiveness of telephone pre-anesthetic evaluations.
This study aims to investigate the implementation of telephone assessments for non-cardiac surgery and their impact on surgical cancellations compared to in-person pre-anesthetic evaluations. The primary question to answer is:
¿Does telephone pre-anesthetic assessment in non-cardiac surgical patients carry a higher risk of surgical cancellations compared to in-person evaluations?
To address this question, investigators will evaluate patients' medical records in two hospitals where patients were assessed using both telephone and in-person modalities.
Study Overview
Status
Detailed Description
The COVID-19 pandemic accelerated the adoption of telemedicine, including its application in preoperative anesthesia evaluations. While the use of telephone assessments in anesthesiology is increasing, there is ongoing debate about their accuracy in identifying medical risks and predicting potential post-surgical outcomes. Preanesthetic evaluations are essential for determining patient suitability for surgery and for classifying surgical risk.
Despite the benefits of increased accessibility and cost reduction associated with telephone assessments, concerns persist regarding their ability to match the thoroughness of in-person evaluations. This is particularly relevant given the potential for higher rates of surgical cancellations.
In Colombia, telephone preanesthetic evaluations for non-cardiac elective surgeries are a recent development that may optimize resource use and enhance patient satisfaction. However, it is crucial to investigate whether they lead to a cancellation rate comparable to that of in-person assessments, as this could be a significant barrier to widespread implementation. This study examines the effectiveness of telephone assessments for non-cardiac surgeries and their impact on surgical cancellations compared to in-person preanesthetic evaluations. A secondary objective of the study is to evaluate the incidence of perioperative complications, including cardiovascular issues, pulmonary complications, bleeding, unexpected ICU admissions, and non-anticipated difficult airways.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Antioquia
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Medellín, Antioquia, Colombia, 050001
- University of Antioquia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who were scheduled for elective non-cardiac surgery.
Exclusion Criteria:
- Pregnant patients.
- Hospitalized patients
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Telephone pre-anesthetic evaluation
Surgical patients scheduled for elective non-cardiac surgery underwent pre-anesthetic evaluation through a telephone consultation, which included a review of medical history, medications, and risk factors made by anesthesiologists.
No physical examination was conducted.
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In-Person pre-anesthetic evaluation
Surgical patients scheduled for elective non-cardiac surgery received an in-person pre-anesthetic evaluation performed by an anesthesiologist, which included a physical examination and a thorough risk assessment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Surgical cancellation incidence
Time Frame: Pre-surgery
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The incidence of surgical procedure cancellation because of a medical condition affecting the patient and the surgery.
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Pre-surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of unanticipated difficult airway
Time Frame: During the surgery
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Incidence of difficulties with facemask ventilation of the upper airway, tracheal intubation, or both.
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During the surgery
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Incidence of perioperative cardiovascular complications
Time Frame: Late postoperative (until 7 days after surgery)
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Incidence of any perioperative cardiovascular complications during intraoperative or postoperative periods: all-cause death, sudden cardiac arrest, congestive heart failure, non-fatal myocardial infarction (MI), pulmonary embolism.
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Late postoperative (until 7 days after surgery)
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Incidence of postoperative mechanical ventilation
Time Frame: early postoperative (until 2 hours after surgery)
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Incidence of postoperative mechanical ventilation.
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early postoperative (until 2 hours after surgery)
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Incidence of perioperative respiratory complications
Time Frame: Late postoperative (until 7 days after surgery)
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The occurrence of respiratory complications in the perioperative period, including pneumonia, can happen within seven days following surgery
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Late postoperative (until 7 days after surgery)
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Incidence of unplanned ICU admission
Time Frame: early postoperative (until 2 hours after surgery)
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Incidence of unplanned ICU admission in the postoperative
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early postoperative (until 2 hours after surgery)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Fabian D Casas, Professor, Universidad de Antioquia
Publications and helpful links
General Publications
- Lozada 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.
- Muñoz L, Reyes LE, Infante S, Quiroga J, Cabrera L, Obando N, et al. Cancelación de procedimientos electivos y su relación con la valoración preanestésica. Rev Repert Med Cir. 17 de abril de 2018;27(1):24-9.
- Thompson T, Brophy T, Modgil V, Pearce I. Remote healthcare consultations: the new era of outpatient medicine. Trends Urol Mens Health. 2020;11(5):25-8.
- Ryu S. Telemedicine: Opportunities and Developments in Member States: Report on the Second Global Survey on eHealth 2009 (Global Observatory for eHealth Series, Volume 2). Healthc Inform Res. junio de 2012;18(2):153-5.
- Prados Castillejo JA. [Telemedicine, also a tool for the family doctor]. Aten Primaria. 2013 Mar;45(3):129-32. doi: 10.1016/j.aprim.2012.07.006. Epub 2012 Sep 11. No abstract available. Spanish.
- Castillo VS, Cano CAG, Gonzalez-Argote J. Telemedicine and mHealth Applications for Health Monitoring in Rural Communities in Colombia: A Systematic Review.
- Aldawoodi NN, Muncey AR, Serdiuk AA, Miller MD, Hanna MM, Laborde JM, Garcia Getting RE. A Retrospective Analysis of Patients Undergoing Telemedicine Evaluation in the PreAnesthesia Testing Clinic at H. Lee Moffitt Cancer Center. Cancer Control. 2021 Jan-Dec;28:10732748211044347. doi: 10.1177/10732748211044347.
- Wongtangman K, Azimaraghi O, Freda J, Ganz-Lord F, Shamamian P, Bastien A, Mirhaji P, Himes CP, Rupp S, Green-Lorenzen S, Smith RV, Medrano EM, Anand P, Rego S, Velji S, Eikermann M. Incidence and predictors of case cancellation within 24 h in patients scheduled for elective surgical procedures. J Clin Anesth. 2022 Dec;83:110987. doi: 10.1016/j.jclinane.2022.110987. Epub 2022 Oct 26.
- Zhang K, Rashid-Kolvear M, Waseem R, Englesakis M, Chung F. Virtual preoperative assessment in surgical patients: A systematic review and meta-analysis. J Clin Anesth. 2021 Dec;75:110540. doi: 10.1016/j.jclinane.2021.110540. Epub 2021 Oct 11.
- Schmidt AP, Modolo NSP, de Amorim CG, Simoes CM, Kraychete DC, Joaquim EHG, Lineburger EB, Papa FV, Fernandes FC, Mendes FF, Guimaraes GMN, Barros GAM, Silva-Jr JM, Navarro E Lima LH, Azi LMTA, Carvalho LIM, Stefani LC, Garcia LV, Malbouisson LMS, Salgado-Filho MF, Nascimento Junior PD, Alves RL, Carvalho VH, Quintao VC, Carmona MJC. Two years of the COVID-19 pandemic: an anesthesiology perspective. Braz J Anesthesiol. 2022 Mar-Apr;72(2):165-168. doi: 10.1016/j.bjane.2022.02.004. Epub 2022 Feb 19. No abstract available.
- Kamdar NV, Huverserian A, Jalilian L, Thi W, Duval V, Beck L, Brooker L, Grogan T, Lin A, Cannesson M. Development, Implementation, and Evaluation of a Telemedicine Preoperative Evaluation Initiative at a Major Academic Medical Center. Anesth Analg. 2020 Dec;131(6):1647-1656. doi: 10.1213/ANE.0000000000005208.
- Garg R, Hoda W. Emergence of Telehealth for anesthesiologists in COVID-19-boon for all! J Anaesthesiol Clin Pharmacol. 2020 Jul-Sep;36(3):417-419. doi: 10.4103/joacp.JOACP_416_20. Epub 2020 Sep 29. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Perioperative Outcomes
- Surgical Cancellation Risk
- Preanesthetic Assessment
- Telephone Preoperative Evaluation
- In-Person Preoperative Evaluation
- Elective Non-Cardiac Surgery
- Surgery Cancellation Rate
- Preanesthetic Evaluation Telemedicine
- Telehealth in Preoperative Care
- Comparison of Preanesthetic Methods
- Risk Assessment for Surgery Cancellation
- Postoperative Complications in Non-Cardiac Surgery
- Patient Satisfaction with Telemedicine
- Remote Preoperative Consultation
- Surgical Risk Management
- Telemedicine vs. In-Person Evaluation
- Retrospective Study in Anesthesiology
- Surgical Outcome Prediction
- Telemedicine in Anesthesiology
- Preanesthetic Teleconsultation
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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