Airway ManagementNCT03856073
The Training and Evaluate Effect on Clinical Airway Management for Novices.
A study testing Novice in people with Airway Management and Education, run by Peking Union Medical College Hospital.
Trial summary
In this self-control experiment, anesthesiologists without experiment of bronchoscopy working in anesthesiology department in Peking Union Medical College Hospital will receive a training and evaluation procedure in simulation and clinical practice about clinical airway management. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Management, Education, Bronchoscopy
- What is being tested?
- Novice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 6 Mar 2019to 2 Jan 2020
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- An anesthesiologist who is working on anesthesia airway management;
- During the research period, he/she worked in the anesthesiology department of Peking Union Medical College Hospital;
- Have no experience of manufacturing bronchoscopy.
Who cannot join
- Cannot complete pre-training assessment; or get more than 3 of modified global rating scale score.
- Cannot complete the training course;
- Cannot complete the post-training evaluation;
- Clinical airway managers were not performed during the study period.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Training and Evaluate Effect of Simulation on Clinical Airway Management for Novices During Perioperative Period
In this self-control experiment, anesthesiologists without experiment of bronchoscopy working in anesthesiology department in Peking Union Medical College Hospital will receive a training and evaluation procedure in simulation and clinical practice about clinical airway management. The objects was (1) to investigate the improvements of manufacturing bronchoscopy in simulation and clinical practice before and after training on simulation, (2) to record the study curve and efforts trainees needed to achieve proficiency and self-confidence on simulation, (3) to record the curve of manufacturing from skilled to unskilled, (4)to evaluate if status manufacturing on simulations could reflect the ones in clinical practice.
Read the detailed description
A modified global rating scale from 1 (unskilled) to 5 (expert) with a score of 3 linked to proficiency, and 5-points Likert from 1 (felt extremely unsure) to 5 (felt extremely confidence) with a score of 4 linked to confidence were used to evaluate during the procedure of training and evaluation.
- Conditions
- Airway Management, Education, Bronchoscopy
- Being tested
- Novice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NoviceBehavioural
Using the simulate device, the novices in bronchoscopy are going to trained and evaluated the ability of driving bronchoscopy in simulate device and clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Novice | Experimental | Anesthesiologists without experiment of manufacturing bronchoscopy. Receives: Behavioral: Novice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Time needed.
Change of time needed to navigate using bronchoscopy.
Measured: Changes from baseline after finishing simulate training, an average of 1 month.
Change of modified global rating scores (GRS).
Change of modified global rating scores (GRS) rating manufacturing skills using bronchoscopy. Total score ranges from 4 to 20 scores at 1-score intervals, higher score matches better skill. Total score is the submission of four subscales, which evaluating central view, mucosal contact, progress and orientation using bronchoscopy, ranges from 1 to 5 scores at 1-score interval, higher scores represent better outcome.
Measured: Changes from baseline after finishing simulate training, an average of 1 month.
Change of Likert score.
Change of Likert score evaluating self-confidence using bronchoscopy. Likert score ranges from 1 to 5 scores at 1-score intervals, higher score with more self-confidence.
Measured: Changes from baseline after finishing simulate training, an average of 1 month.
Secondary outcomes (3)
Inconsistency of evaluation of time needed between simulate and clinical practice.
Inconsistency of time needed to navigate using bronchoscopy.
Measured: 1 day, 2 days, and every continuous 7 days until 1 month after training.
Inconsistency of evaluation of modified global rating scores between simulate and clinical practice.
Inconsistency of modified global rating scores (GRS) rating manufacturing skills, using bronchoscopy. Total score ranges from 4 to 20 scores at 1-score intervals, higher score matches better skill. Total score is the submission of four subscales, which evaluating central view, mucosal contact, progress and orientation using bronchoscopy, ranges from 1 to 5 scores at 1-score interval, higher scores represent better outcome.
Measured: 1 day, 2 days, and every continuous 7 days until 1 month after training.
Inconsistency of evaluation of Likert socre between simulate and clinical practice.
Inconsistency of Likert score evaluating self-confidence using bronchoscopy. Likert score ranges from 1 to 5 scores at 1-score intervals, higher score with more self-confidence.
Measured: 1 day, 2 days, and every continuous 7 days until 1 month after training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start6 Mar 2019 (estimated)
- Primary completion31 May 2019 (estimated)
- Study completion2 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunhua Yu, Peking Union Medical College Hospital
- Investigators
- Chunhua Yu, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856073
- Sponsor's protocol ID
- zs1809（novice）
- Status last verified
- Mar 2019
- First submitted
- 14 Feb 2019
- Last updated
- 6 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Training and Evaluate Effect of Simulation on Clinical Airway Management for Novices During Perioperative Period
- ClinicalTrials.gov ID
- NCT03856073
- Acronym / sponsor ID
- zs1809（novice）
- Conditions
- Airway Management, Education, Bronchoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 6 Mar 2019 (estimated)
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 2 Jan 2020 (estimated)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this self-control experiment, anesthesiologists without experiment of bronchoscopy working in anesthesiology department in Peking Union Medical College Hospital will receive a training and evaluation procedure in simulation and clinical practice about clinical airway management. The objects was (1) to investigate the improvements of manufacturing bronchoscopy in simulation and clinical practice before and after training on simulation, (2) to record the study curve and efforts trainees needed to achieve proficiency and self-confidence on simulation, (3) to record the curve of manufacturing from skilled to unskilled, (4)to evaluate if status manufacturing on simulations could reflect the ones in clinical practice.
Detailed description
A modified global rating scale from 1 (unskilled) to 5 (expert) with a score of 3 linked to proficiency, and 5-points Likert from 1 (felt extremely unsure) to 5 (felt extremely confidence) with a score of 4 linked to confidence were used to evaluate during the procedure of training and evaluation.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novice | Experimental | Behavioral: NoviceAnesthesiologists without experiment of manufacturing bronchoscopy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- An anesthesiologist who is working on anesthesia airway management;
- During the research period, he/she worked in the anesthesiology department of Peking Union Medical College Hospital;
- Have no experience of manufacturing bronchoscopy.
Key exclusion criteria (4 listed)
- Cannot complete pre-training assessment; or get more than 3 of modified global rating scale score.
- Cannot complete the training course;
- Cannot complete the post-training evaluation;
- Clinical airway managers were not performed during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NoviceUsing the simulate device, the novices in bronchoscopy are going to trained and evaluated the ability of driving bronchoscopy in simulate device and clinical practice. | Behavioural | Novice |
Primary outcome
Change of Time needed.
Time frame: Changes from baseline after finishing simulate training, an average of 1 month.
Change of time needed to navigate using bronchoscopy.
Change of modified global rating scores (GRS).
Time frame: Changes from baseline after finishing simulate training, an average of 1 month.
Change of modified global rating scores (GRS) rating manufacturing skills using bronchoscopy. Total score ranges from 4 to 20 scores at 1-score intervals, higher score matches better skill. Total score is the submission of four subscales, which evaluating central view, mucosal contact, progress and orientation using bronchoscopy, ranges from 1 to 5 scores at 1-score interval, higher scores represent better outcome.
Change of Likert score.
Time frame: Changes from baseline after finishing simulate training, an average of 1 month.
Change of Likert score evaluating self-confidence using bronchoscopy. Likert score ranges from 1 to 5 scores at 1-score intervals, higher score with more self-confidence.
3 secondary outcomes
Inconsistency of evaluation of time needed between simulate and clinical practice.
Time frame: 1 day, 2 days, and every continuous 7 days until 1 month after training.
Inconsistency of evaluation of modified global rating scores between simulate and clinical practice.
Time frame: 1 day, 2 days, and every continuous 7 days until 1 month after training.
Inconsistency of evaluation of Likert socre between simulate and clinical practice.
Time frame: 1 day, 2 days, and every continuous 7 days until 1 month after training.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunhua Yu study chair
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Novice in people with Airway Management and Education, run by Peking Union Medical College Hospital.
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 3 inclusion and 4 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 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Chunhua Yu, Doctor (010-69152030, counsissis@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Time needed. (time frame: Changes from baseline after finishing simulate training, an average of 1 month.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2019.