Development and Validation of Metrics Lumbar Labor Epidural Catheter Placement

NCT02179879 | Completed

• 1 other identifier: ECM4(U)01/10/13
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Procedural skills play an important role in anaesthetic expertise. More focused training and assessment of procedural skills will be needed in the future as training moves from an apprenticeship based training system to competency based assessment. Currently various techniques exists to assess procedural skills of anaesthetist. For epidural catheter placement, task specific check list, global rating scales and cumulative sum techniques have been developed and validated. These techniques aim either for better qualitative outcome sacrificing objectivity or rely on self-reporting. A decrease in objectivity in turn hampers inter-rater reliability which is an essential component of a valid assessment model. Checklists type assessments force the developer to comprehensively characterize the procedure of interest and then validate the completed procedure characterization. This approach has been quantitatively shown to have higher assessment reliability levels compared to Likert-scale assessment. The objective of the project is to develop and validate a comprehensive procedure characterization for labor epidural catheter placement. Another objective is to compare this new assessment tool with existing checklist and global rating scale for labor epidural to establish concurrent validity.5 A well-developed objective, validated procedure characterization serves as a master tool which has multiple applications. It helps to build a training programme for the procedure, allows providing metrics based feedback to trainees using simulator, helps to assess the performance of trainees and in future might be used as benchmark to allow competency based progression in the training.

Conditions

Labor Pain

Keywords

labor,epidural,analgesia

Outcome Measures

Primary Outcomes (1)

• Construct validitiy

  a set of procedures for evaluating a testing instrument based on a degree to which the test terms identify the quality, ability or trait it was designed to measure.In our study we aim to see if the metrics developed will be able to differentiate between experts and novices in performing the porcedure

  WIthin 12 months post recording epidural procedure video

Secondary Outcomes (2)

• Concurrrent validity

  within 12 months following completion of epidural video recording

• Interrater reliability

  12 months from time of aquiring the epidural video

Study Arms (1)

Video validation group

This will include video taping of experts (defined as one who has performed more than 500 labor epidurals in preceding 5 year period) and novices (defined as one who has done less than 50 epidurals in preceeding 2 years) perfoming labor epidural

Other: Video validation

Interventions

Video validation OTHER

Video taping of anaesthetist (experts and novices) perfoming labor epidural.

Video validation group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Expertes and novice anaesthetist perfoming labor epidural analgesia

You may qualify if:

• an expert is defined as one who has performed more than 500 labor epidurals in preceding 5 year period
• novice (defined as one who has done less than 50 epidurals in previous 2 years)

You may not qualify if:

• Non consenting anaesthetist
• Patients not consenting for video recording

Sponsors & Collaborators

• Cork University Hospital: lead

Study Sites (1)

Cork University Hospital

Cork,Ireland, Ireland

Location

Related Publications (1)

• Kallidaikurichi Srinivasan K, Gallagher A, O'Brien N, Sudir V, Barrett N, O'Connor R, Holt F, Lee P, O'Donnell B, Shorten G. Proficiency-based progression training: an 'end to end' model for decreasing error applied to achievement of effective epidural analgesia during labour: a randomised control study. BMJ Open. 2018 Oct 15;8(10):e020099. doi: 10.1136/bmjopen-2017-020099.

  PMID: 30327396 DERIVED

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karthikeyan Kallidaikurichi Srinivasan, FCARCSI,MD

  Cork University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Registrar,Anaesthetics,Cork University Hospital

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: July 2, 2014
• Study Start: November 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 28, 2015

Record last verified: 2015-08

Locations

IE (1)