NCT04735250|UnknownDMC
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Sponsor study identifier
observational
150
1 country
1
Study Start
August 25, 2020
Actual (reported)Primary Completion
July 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Uses the video stylet with different angulation to assist the orotracheal tube passing the oral cavity, oropharynx and advanced into the trachea
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 25, 2020
Actual (reported)January 21, 2021
Actual (reported)February 3, 2021
Actual (reported)July 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
success rate of video stylet angulation and successful first tube attempt in 60 seconds
successful rate of the properly video stylet angulation passing through oral cavity into trachea. Time: TTI(time taken advancement) is less than 60 seconds in first tube attempt, it defines successful; TTI(time taken advancement) is over 60 seconds in first tube attempt, it defines unsuccessful.
During procedure
success rate of video stylet angulation and successful first tube attempt in Lung's ventilation
successful rate of the properly video stylet angulation passing through oral cavity into trachea. Lung's ventilation: The lung's ventilation is success.
During procedure
time taken advancement(TTI)
time taken advancement from oral cavity into trachea in each time interval
During procedure
assessment of difficult intubation(IDS)
post-intubation induced oropharyngeal bleeding, hoarseness and sore throat
Day 2(the day after the operation)
Uses the video stylet with 45 degree(The tip of the trachway in 45°-55°) to assist the orotracheal tube passing the oral cavity, oropharynx and advanced into the trachea
Uses the video stylet with 70 degree(The tip of the trachway in 60°-70°) to assist the orotracheal tube passing the oral cavity, oropharynx and advanced into the trachea
Uses the video stylet with 90 degree(The tip of the trachway in 80°-90°) to assist the orotracheal tube passing the oral cavity, oropharynx and advanced into the trachea
Adult(20 to 65 years old)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Sanmin District, 807, Taiwan
* undergoing surgery with general anesthesia(GA) * ASA(American Society of Anesthesiologists):Ι to III * 20 to 65 years old * mouth open \> 3cm * the systemic disease exclusion/conscious clear and without major Neurocognitive Disorder
Chia-Heng Lin, MD
Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital
First Submitted
January 21, 2021
First Posted
February 3, 2021
Study Start
August 25, 2020
Actual (reported)Primary Completion
July 31, 2022
Estimated (date passed)Impact of a Intra-tracheal Intubation With Curarization or Without Curarization
Assessment of difficult intubation by Intubation Difficulty Scale(The Intubation Difficulty Scale, IDS, 1997) is required after intubation. Number of Attempts\>1, score "N1"; Number of Operators \>1, score "N2"; Number of Alternative Techniques, score "N3"; Comark Grade -1, score "N4"; Lifting Force Required Normal, score "N5=0"; Lifting Force Required Increased, score "N5=1"; Laryngeal Pressure Not applied, score "N6=0"; Laryngeal Pressure Applied, score "N6=1"; Vocal Cord Mobility Abducion, score "N7=0"; Vocal Cord Mobility Adducion, score "N7=1". IDS=Sum of scores(N1-N7). If IDS score gains "0" means "Easy", "0\<IDS≤5" means "Slight Difficulty", "5\<IDS" means "Moderate to Major Difficulty", "IDS=∞" means "Impossible intubation".
During procedure
assessment of Glottic grade(Cormack Grade)
Assessment of Glottic grade(Cormack Grade) is required after intubation. The definitions of grade: Grade 1: full view of the glottis; Grade 2a: partial view of the glottis; Grade 2b: arytenoids only; Grade 3: epiglottis only; Grade 4: neither glottis or epiglottis identified
During procedure
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 3, 2021
Record last verified: 2021-01
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Source: ClinicalTrials.gov.
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