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EducationNCT02718794

Simulation-based and Problem-based Learning for Difficult Airway Management

A study testing Simulation training and Problem-based learning in people with Education, run by Siriraj Hospital at 1 site in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 24 to 37 yearsHealthy volunteers can take part
Conditions the study is for
Education
What is being tested?
Simulation training and Problem-based learning
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteThailand
Study dates
Aug 2015to Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 24 to 37 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Nurse anesthetist students in the academic year of 2015

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

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

+66897942082

dao_pari@yahoo.com

Phongthara Vichitvejpaisal, M.D Ph.D contact

+66818384393

phongthara@gmail.com

Thailand1 site, 1 recruiting
  • Parichad Apidechakul

    Nonthaburi, Changwat Nonthaburi, 10700

    Parichad Apidechakul, B.Ns.M.P. A., +66897942082, dao_pari@yahoo.com

    Phongthara Vijitvejpaisal, M.D.Ph.D., +66818384393, phongthara@gmail.com

    Recruiting

Other trials in Thailand

About this study

Official title: Crossover Study in Simulation-based and Problem-based Learning in Practice Guideline for Difficult Airway Management

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.

Read more

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.

Read the detailed description

Introduction Teaching and learning of difficult airway management are considered to be an essential skill in anesthesiology. Assessment of the training program requires a currently established guideline. Recent studies revealed that the management of the airway was the most sophisticated maneuver for all anesthesia providers, since it is related to morbidity and mortality circumstances. It appeared in 6.2% of endotracheal intubations in the operating theater. In addition, difficult intubation with ventilation occurred in 1.5%, of the procedures; impossible intubation and difficult ventilation 0.3 %; and "can't intubate, can't ventilate" (CICV) situation, 0.07%.

Normally, most anesthesia personnel perform endotracheal intubation under general anesthesia. However, they occasionally come across difficult airways. This becomes a life- and-death condition that may lead to uneventful sequelae. In practice, a difficult airway is defined as either troublesome facemask ventilation or tracheal intubation. 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. In addition, updated difficult airway algorithm helps them manage the patient's airway at the right time.

After graduation, registered nurses need to spend one more year on a training program to become nurse anesthetists, serving as either an anesthesiologist's assistant or a general practitioner's helper. During the one-year training program, nurse anesthetist students intensively study theories and practical skills in anesthesia, using manikins to living patients. However, effective training in airway management results from the learners' competences and from a diversity of teaching techniques.

Currently, the educational tool in the anesthesia curriculum is typically simulation-based learning (SBL) and problem-based learning (PBL) courses, both of which have been widely accepted in many educational institutes. They yield a promising outcome amongst students of professionalism. The SBL provides high-level learning circumstances to help students gain their experiences. The diagnostic and feedback system help learners correct their mistakes with confidence. However, PBL allows students to present their informative knowledge, resulting in retention and integration of learning with clinical experience. In addition, self-directed learning gives them creative thinking. Instructors act as facilitators who empower students to implement their own strategic plan of learning.

Either SBL or PBL has its unique process to assess participants' core knowledge. Furthermore, difficult airway management has become a distinguished means in the training curriculum. As a result, we designed a cross-over study to determine the learning achievement of nurse anesthetist students in difficult airway management.

Objectives To study the learning achievement and relative growth of knowledge of the two learning techniques: SBL and PBL.

Methods Thirty-six nurse anesthetist students in Academic Year 2015, Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, volunteered to join the study project without any honorarium. The benefit of taking part in the study was only knowledge and clinical experience gained. The students were informed about the significance of the research under the faculty policy as well as the learning objectives in details. 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 PBL learning session comprised four different clinical questions together with educational resources for one hour self-study. Consequently, all students spent two more hours on presentation and discussion of knowledge information in front of the class. The SBL learning session consisted of the same clinical scenarios as PBL. All learners spent three hours in the environment of a well-equipped operating theater with a standardized patient or a high-fidelity manikin. Then they joined the debriefing forum given by an attending staff.

The 40-item, multiple choices exam was developed under the table of specifications and knowledge map in regard to difficult airway management guidelines. The paper-pencil test comprised of evaluation of the airway, basic preparation of difficult airway management, strategy of endotracheal intubation and extubation, and follow up care.

The correctness and appropriateness of the test (content validity) were determined by three board-certified anesthesiologists who had at least 10 years of experience in anesthesia and were not involved in the project. 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 using the Statistical Package for Social Sciences for Windows, release 18. Statistically significant differences were considered when there was a p value of < 0.05 with a 95% confidence interval.

Conditions
Education
Being tested
Simulation training, Problem-based learning
Keywords
Simulation Training [I02.903.847], Problem-Based Learning [F02.463.425.720], Airway Management [E02.041]

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Simulation trainingProcedure or surgery

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

  • Problem-based learningProcedure or surgery

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

Study groups in NCT02718794
Study groupRoleWhat they receive
Simulation training firstExperimentalA highly customized interactive medium or program that allows individuals to learn and practice real world activities in an accurate, realistic, safe and secure environment.
Receives: Procedure: Simulation training; Procedure: Problem-based learning
Problem-based learning firstExperimentalInstructional use of examples or cases to teach using problem-solving skills and critical thinking.
Receives: Procedure: Simulation training; Procedure: Problem-based learning

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Learning achievement

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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2016 (estimated)
  2. Study startAug 2015
  3. Primary completionMay 2016 (estimated)
  4. Study completionJun 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02718794
Sponsor's protocol ID
233/2558(EC4)
Status last verified
Mar 2016
First submitted
16 Mar 2016
Last updated
24 Mar 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • 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.

    PubMed 23364566
  • 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.

    PubMed 24368556
  • 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.

    PubMed 16146473
  • 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.

    PubMed 22293664
  • 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.

    PubMed 16374169
  • 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.

    PubMed 25392805
  • 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.

    PubMed 25990498
  • 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.

    PubMed 22696559
  • 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.

    PubMed 22474801
  • 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.

    PubMed 24982673
  • 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.

    PubMed 18436497
  • 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.

    PubMed 10781266
  • 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.

    PubMed 23135259
  • 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.

    PubMed 21447489
  • 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.

    PubMed 24709760

Questions about this trial

What is this clinical trial studying?

A study testing Simulation training and Problem-based learning in people with Education, run by Siriraj Hospital at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Parichad Apidechakul, B.Ns, M.P.A. (+66897942082, dao_pari@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Learning achievement (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02718794, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2016.

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