A Trial to Determine the Effect of Simulation Based Training on Initial Performance of Ultrasound Guided Axillary Brachial Plexus Blockade in a Clinical Setting

NCT01965314 | Terminated

• 1 other identifier: Haystack USgABPB sim-training
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators hypothesize that virtual reality based training offers an additional learning benefit over standard training (using cadaveric dissection and human volunteers) in preparing novice anaesthetists to perform their first Ultrasound guided Axillary Brachial Plexus Blockade (USgABPB) in the clinical setting. Investigators hope that this body of work will aid the development of a visuo-haptic simulator used to improved training of doctors in performing USgABPB. Ultimately any patient having this procedure carried out in the future should benefit. In particular it will avoid the need for novice trainees to practice new techniques on patients.

Conditions

Anesthesiology Training

Keywords

ultrasound guided regional anaesthesia; upper limb surgery; ultrasound guided axillary brachial plexus blockade

Outcome Measures

Primary Outcomes (1)

• positive total of procedural checklist items

  Yes or No which of the following elements were performed 1. Conducts clear pre-procedural consultation with patient 2. Obtains informed consent 3. Secures IV Access 4. Applies appropriate monitoring 5. Prepares equipment and emergency drugs appropriate for standard regional anaesthesia procedures 6. Selects appropriate local anaesthetic agents 7. Works with trained assistant 8. Prepares sterile Regional Trolley 9. Selects linear broadband transducer with 5-13MHz frequency 10. Uses US coupling gel and sterile cover 11. Uses 50 mm needle 12. Positions patient semi recumbent with head supported for comfort 13. Positions operative arm in-90° abduction and externally rotates and supports in comfortable position 14. Elevates bed position to appropriate level 15. Positions the performer and US screen on the operative side with the screen cephalad to the trolley etc...(limited by character count)

  As assessed by retrospective video analysis of procedure (from patient positioning to assessment of adequacy of block) by two blinded experts (within 6 months of procedure)

Secondary Outcomes (6)

• procedural times

  (During procedure) From patient and equipment positioning to assessment of adequacy of block

• number of needle passes

  during the procedure

• block success

  within 15 mins of the procedure

• participating anaesthetist confidence levels

  immediately following performance of the USgABPB (within 30 minutes)

• patient satisfaction measure

  prior to discharge from the post anaesthesia care unit (recovery room) - (not more than 2 hours following completion of surgical procedure requiring anaesthesia)

Study Arms (2)

Traditional Training Group

PLACEBO COMPARATOR

These subjects will be offered multimodal training. This will be comprised of demonstration by suitably trained individuals of relevant anatomy using pre-existing cadaveric samples, performing ultrasound scans of the relevant areas on volunteers under expert supervision, and the practice of needle insertion under ultrasound-guidance using commonly used tissue phantoms (turkey breasts).

Other: Traditional training

Simulation Training Group

ACTIVE COMPARATOR

In addition to traditional training the SG group will participate in a period of simulator based training. Following initial familiarization with the simulator these participants will identify relevant structures and follow their course in the virtual arm. They will insert a virtual needle into the virtual environment and advance it using an in-plane technique towards various target structures. They will be given immediate directed computer generated feedback and offered the opportunity for repetitive, deliberate practice. The simulator, which these participants will use, will comprise of a PHANTOM Desktop (http://www.sensable.com/), an haptic immersive workbench and the H3D API (http://www.sensegraphics.se/). The SG subject will scan and perform procedure specific tasks on a virtual arm. Training will continue until they reach proficiency levels set by experts using the same simulator.

Other: Simulation based training; Other: Traditional training

Interventions

Simulation based training OTHER

In addition to traditional training (as delivered to participants in the Traditional Training Group), participants in the Simulation Training Group will receive the following:- Following initial familiarization with the simulator SG participants will identify relevant structures and follow their course in the virtual arm. They will insert a virtual needle into the virtual environment and advance it using an in-plane technique towards various target structures. They will be given immediate directed computer generated feedback and offered the opportunity for repetitive, deliberate practice. The simulator, which SG participants will use, will comprise of a PHANTOM Desktop (http://www.sensable.com/), an haptic immersive workbench and the H3D API (http://www.sensegraphics.se/). The SG subject will scan and perform procedure specific tasks on a virtual arm. Training will continue until they reach proficiency levels set by experts using the same device

Simulation Training Group

Traditional training OTHER

Subjects will be offered standardized multimodal training. This will be comprised of demonstration by suitably trained individuals of relevant anatomy using pre-existing cadaveric samples, performing ultrasound scans of the relevant areas on volunteers under expert supervision, and the practice of needle insertion under ultrasound-guidance using commonly used tissue phantoms (turkey breasts).

Simulation Training Group; Traditional Training Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA grades I and II
• Age 18-80 years
• Capacity to consent
• Already consented for ultrasound guided axillary brachial plexus blockade
• Body Mass index 20 - 26

You may not qualify if:

• Contraindication to regional anaesthesia
• Language barrier
• Psychiatric history
• Pregnancy

Sponsors & Collaborators

• Cork University Hospital: lead

Study Sites (1)

Cork University Hospital

Cork, Cork, Ireland

Location

Related Publications (1)

• O'Sullivan O, Iohom G, O'Donnell BD, Shorten GD. The effect of simulation-based training on initial performance of ultrasound-guided axillary brachial plexus blockade in a clinical setting - a pilot study. BMC Anesthesiol. 2014 Nov 26;14:110. doi: 10.1186/1471-2253-14-110. eCollection 2014.

  PMID: 25844062 DERIVED

Study Officials

• George Shorten, PhD

  Cork University Hospital & University College Cork

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow, Department of Anaesthesia

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: October 18, 2013
• Study Start: July 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 2, 2016

Record last verified: 2016-02

Locations

IE (1)