Pilot Study of Anesthesiologists' Preoperative Prediction of Postoperative Intensive Care Unit Admission
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVan Training and Research Hospital
About this trial
This prospective observational pilot study will evaluate how accurately anesthesiologists can predict, before a procedure, whether an adult patient will require admission to an intensive care unit (İCU) after surgery or an endoscopic procedure.
Before each procedure, the anesthesiologist will record whether postoperative intensive care unit (İCU) care is expected and the clinical factors influencing this assessment. No changes will be made to the patient's usual medical care. After the procedure, the researchers will record whether the patient was admitted to the İCU and whether the admission was planned or unplanned. Additional information, including İCU and hospital length of stay, need for organ support, and in-hospital mortality, will also be collected when applicable.
The pilot study will also assess whether the planned data collection process is practical and whether the required study information can be collected completely before conducting the main prospective study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older.
Undergoing an eligible surgical or endoscopic procedure on a predefined study day.
The american society of anesthesiologists (ASA) Physical Status of I-II and undergoing a major surgical or endoscopic procedure, or ASA Physical Status of III-V and undergoing an eligible surgical or endoscopic procedure.
Preoperative anesthesiology assessment completed before the procedure.
Disqualifiers
Age younger than 18 years.
ASA Physical Status of I-II and undergoing a minor or non-major procedure.
Undergoing cardiac surgery.
Already admitted to an intensive care unit before the index procedure.
Trial population
The study population will consist of adult patients undergoing eligible surgical or endoscopic procedures in the participating operating rooms and endoscopy units on the predefined study days. Patients with The american society of anesthesiologists (ASA) Physical Status of I-II will be included if they undergo a major procedure, while patients with ASA Physical Status of III-V will be considered for inclusion regardless of procedural magnitude, provided that all other eligibility criteria are met. Preoperative clinical assessment will be completed before the procedure, and postoperative outcomes will be recorded prospectively.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Preoperative Clinical Prediction of Postoperative ICU Admission
Other interventionBefore the index procedure, the anesthesiologist will record whether postoperative intensive care unit admission is anticipated based on routine preoperative clinical assessment. This assessment is observational and will not alter routine patient care.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Adult Surgical and Endoscopic Procedure Cohort1 intervention
Trial outcomes
Primary outcomes
1
Accuracy of Preoperative Prediction of Postoperative Intensive Care Unit Admission
Overall prediction accuracy will be calculated as the proportion of evaluable patients for whom the anesthesiologist's preoperative prediction of postoperative intensive care unit (İCU) need agrees with actual İCU admission status within 24 hours after the index procedure. Patients with mandatory postoperative İCU admission according to institutional protocol will not be included in this primary analysis.
Time frame
Within 24 hours after the index surgical or endoscopic procedureSecondary outcomes
1
Unanticipated Postoperative Intensive Care Unit Admission
The proportion of evaluable patients who are admitted to the intensive care unit (İCU) within 24 hours after the index procedure despite postoperative İCU care not being anticipated during the preoperative anesthesiology assessment.
Time frame
Within 24 hours after the index surgical or endoscopic procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov