NCT02718794

Brief Summary

Teaching and learning of difficult airway management are considered to be an essential skill in anesthesiology. As a result, doctors and nurses in anesthesia have to be vigilant in every step including airway assessment, equipment preparation and strategic planning of the process. During the one-year training program, nurse anesthetist students intensively study theories and practical skills in anesthesia, using manikins to living patients. Difficult airway management has become a distinguished means in the training curriculum. In addition, the educational tool in the anesthesia curriculum is typically simulation-based learning (SBL) and problem-based learning (PBL) courses. As a result, we designed a cross-over study to determine the learning achievement of nurse anesthetist students in difficult airway management. The objectives were to study the learning achievement and relative growth of knowledge of the two learning techniques: SBL and PBL. Thirty-six nurse anesthetist students in Academic Year 2015, volunteered to join the study project. After signing the consent form, they were randomly put into two groups: A (n = 17) and B (n = 19). As designed by the cross-over study, students in group A attended SBL and after 6 weeks, they focused on PBL, and vice versa for group B. The 40-item, multiple choices exam was developed in regard to difficult airway management guidelines. The correctness and appropriateness of the test (content validity) were determined by three board-certified anesthesiologists. The try out of the test was performed by 10 novice nurse anesthetists. The index of item objective congruence was 0.82 with Kuder Richardson 21 of 0.8. The assessed criterion-referenced item difficulty and discrimination index were 0.4-0.6 and 0.6-0.8 respectively. The pretest (X1, X2) were post-test ((Y1, Y2) were performed in the consequence. The relative growth of knowledge (G1, G2) was calculated as follows: G1 = 100 (Y1 - X1) / (F - X1) % G2 = 100 (Y2 - X2) / (F - X2) % Where F was the full scores of the learning course Statistics analysis The test scores and relative growth of knowledge between the two groups were expressed as mean and standard deviation. Comparison between the two groups was performed by repeated measure ANOVA. Statistically significant differences were considered when there was a p value of \< 0.05 with a 95% confidence interval.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

March 24, 2016

Status Verified

March 1, 2016

Enrollment Period

9 months

First QC Date

March 16, 2016

Last Update Submit

March 23, 2016

Conditions

Keywords

Simulation Training [I02.903.847]Problem-Based Learning [F02.463.425.720]Airway Management [E02.041]

Outcome Measures

Primary Outcomes (1)

  • Learning achievement

    student achievement scores from pretest 1( X1), post-test 1 (Y1) and pretest 2 (X2) , post-test2 (Y2)

    3 months

Other Outcomes (1)

  • Relative growth of knowledge

    3 months

Study Arms (2)

Simulation training first

EXPERIMENTAL

A highly customized interactive medium or program that allows individuals to learn and practice real world activities in an accurate, realistic, safe and secure environment.

Procedure: Simulation trainingProcedure: Problem-based learning

Problem-based learning first

EXPERIMENTAL

Instructional use of examples or cases to teach using problem-solving skills and critical thinking.

Procedure: Simulation trainingProcedure: Problem-based learning

Interventions

spend 3 hours for each of 10 nurse anesthetist students with 4 scenarios

Problem-based learning firstSimulation training first

spend 3 hours for PBL steps with each of 10 nurse anesthetist students

Problem-based learning firstSimulation training first

Eligibility Criteria

Age24 Years - 37 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Nurse anesthetist students in the academic year of 2015

You may not qualify if:

  • The unwilling nurse anesthetist students in the academic year of 2015

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parichad Apidechakul

Nonthaburi, Changwat Nonthaburi, 10700, Thailand

RECRUITING

Related Publications (15)

  • Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. No abstract available.

  • Lorello GR, Cook DA, Johnson RL, Brydges R. Simulation-based training in anaesthesiology: a systematic review and meta-analysis. Br J Anaesth. 2014 Feb;112(2):231-45. doi: 10.1093/bja/aet414. Epub 2013 Dec 23.

  • Hesselfeldt R, Kristensen MS, Rasmussen LS. Evaluation of the airway of the SimMan full-scale patient simulator. Acta Anaesthesiol Scand. 2005 Oct;49(9):1339-45. doi: 10.1111/j.1399-6576.2005.00856.x.

  • Smithburger PL, Kane-Gill SL, Ruby CM, Seybert AL. Comparing effectiveness of 3 learning strategies: simulation-based learning, problem-based learning, and standardized patients. Simul Healthc. 2012 Jun;7(3):141-6. doi: 10.1097/SIH.0b013e31823ee24d.

  • Steadman RH, Coates WC, Huang YM, Matevosian R, Larmon BR, McCullough L, Ariel D. Simulation-based training is superior to problem-based learning for the acquisition of critical assessment and management skills. Crit Care Med. 2006 Jan;34(1):151-7. doi: 10.1097/01.ccm.0000190619.42013.94.

  • Komasawa N, Sanuki T, Fujiwara S, Haba M, Ueki R, Kaminoh Y, Minami T. Significance of debriefing methods in simulation-based sedation training courses for medical safety improvement in Japan. Springerplus. 2014 Oct 28;3:637. doi: 10.1186/2193-1801-3-637. eCollection 2014.

  • Tanaka PP, Pessoa R, Fernandes R, Brodsky J. [What is missing for difficult airway management in the 21st century]. Rev Bras Anestesiol. 2015 May-Jun;65(3):235-6. doi: 10.1016/j.bjan.2013.11.008. Epub 2014 Sep 26. No abstract available. Portuguese.

  • Ross AJ, Kodate N, Anderson JE, Thomas L, Jaye P. Review of simulation studies in anaesthesia journals, 2001-2010: mapping and content analysis. Br J Anaesth. 2012 Jul;109(1):99-109. doi: 10.1093/bja/aes184.

  • Lucisano KE, Talbot LA. Simulation training for advanced airway management for anesthesia and other healthcare providers: a systematic review. AANA J. 2012 Feb;80(1):25-31.

  • Chilkoti G, Mohta M, Wadhwa R, Saxena AK. Problem-based learning research in anesthesia teaching: current status and future perspective. Anesthesiol Res Pract. 2014;2014:263948. doi: 10.1155/2014/263948. Epub 2014 May 29.

  • Lui PW. Things we should know when designing simulator-based teaching in difficult airway management. J Chin Med Assoc. 2008 Apr;71(4):163-5. doi: 10.1016/S1726-4901(08)70098-4. No abstract available.

  • Langeron O, Masso E, Huraux C, Guggiari M, Bianchi A, Coriat P, Riou B. Prediction of difficult mask ventilation. Anesthesiology. 2000 May;92(5):1229-36. doi: 10.1097/00000542-200005000-00009.

  • Langeron O, Cuvillon P, Ibanez-Esteve C, Lenfant F, Riou B, Le Manach Y. Prediction of difficult tracheal intubation: time for a paradigm change. Anesthesiology. 2012 Dec;117(6):1223-33. doi: 10.1097/ALN.0b013e31827537cb.

  • Cook TM, Woodall N, Harper J, Benger J; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 2: intensive care and emergency departments. Br J Anaesth. 2011 May;106(5):632-42. doi: 10.1093/bja/aer059. Epub 2011 Mar 29.

  • Vuori M, Akila R, Kalakoski V, Pentti J, Kivimaki M, Vahtera J, Harma M, Puttonen S. Association between exposure to work stressors and cognitive performance. J Occup Environ Med. 2014 Apr;56(4):354-60. doi: 10.1097/JOM.0000000000000129.

Study Officials

  • Parichad Apidechakul, B.Ns, M.P.A.

    Department of Anesthesiology, Faculty of Medicine, Siriraj hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Parichad Apidechakul, B.Ns, M.P.A.

CONTACT

Phongthara Vichitvejpaisal, M.D Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty of Medicine Siriraj Hospital

Study Record Dates

First Submitted

March 16, 2016

First Posted

March 24, 2016

Study Start

August 1, 2015

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

March 24, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will share

Locations