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Simulation Based Training for Medical Procedures, An Alternative to the Traditional See One, Do One Method

Simulation-Enhanced Blended Learning Versus Traditional See One, Do One Approach for Training Clinical Procedural Skills: A Randomized Non-Inferiority Trial - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/106143
Enrollment
120
Registered
2026-03-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Simulation with blended learning: Structured learning module of each procedure will be shown before through learning management system. This will be followed by skill practice in skill

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Medical Professional Inclusion Criteria 1. Willingness to participate 2. Ability to complete both instructional and assessment components Patient Inclusion Criteria 1.Adult patients aged 18 to 65 years. 2.Patients scheduled for elective surgical or diagnostic procedures in which one or more of the following procedures are indicated as part of routine standard of care: oIntravenous cannulation oArterial puncture for blood gas analysis oAirway management, including endotracheal intubation or laryngeal mask airway (LMA) insertion 3.Patients undergoing procedures under general anaesthesia or monitored anaesthesia care, in accordance with established institutional protocols. 4.Patients who have received a Patient Information Sheet detailing the study objectives and the involvement of supervised trainees, and who have provided written informed consent for participation. 5.Patients deemed clinically appropriate for trainee-performed procedures, as determined by the supervising consultant anaesthesiologist, with no anticipated increase in risk compared with routine practice.

Exclusion criteria

Exclusion criteria: 1.Refusal to participate or inability to provide informed consent. 2.Patients requiring emergency or urgent interventions, where trainee involvement may compromise timely clinical management. 3.Patients classified as ASA physical status III or higher. 4.Presence of a known or anticipated difficult airway, including but not limited to Mallampati class III or IV, limited mouth opening, cervical spine instability, or prior documentation of difficult intubation. 5.History of multiple unsuccessful attempts at intravenous cannulation or arterial puncture, or presence of conditions that significantly increase procedural risk, including: oSevere peripheral vascular disease oKnown coagulopathy or bleeding disorders oLocal infection, inflammation, or trauma at the intended procedural site 6.Patients requiring advanced, non-routine, or rescue airway techniques beyond standard endotracheal intubation or LMA insertion. 7.Pregnant patients, due to altered physiological considerations and heightened ethical safeguards. 8.Patients with hemodynamic or cardiorespiratory instability, or those considered to be at high anaesthetic risk, as assessed by the attending anaesthesiologist. 9.Patients concurrently enrolled in another interventional clinical study involving procedural or anaesthetic outcomes, where participation could introduce confounding or additional risk.

Design outcomes

Primary

MeasureTime frame
To compare overall procedural performance between Simulation enhanced blended group and See One Do One groups using structured checklist-based assessment and global rating scales in simulated and clinical environments.Timepoint: During Procedure

Secondary

MeasureTime frame
1.To assess learner satisfaction, perceived confidence, and acceptability of BL versus SODO methods. 2. To explore the feasibility, engagement, and completion rates of the BL modules and skill-room peer practice compared with traditional clinical exposure Timepoint: After procedure

Countries

India

Contacts

Public ContactDr Subodh Kumar

AIIMS

subodh.08aiims@gmail.com9793184350

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026