Intubation Clinical Trial
Official title:
For Nasotracheal Intubation With Video Rigid Stylet, Which Nostril is Better? A Randomized Clinical Trial
Verified date | April 2022 |
Source | Peking University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To determine which nostril is more suitable for nasotracheal intubation with video rigid stylet.
Status | Completed |
Enrollment | 50 |
Est. completion date | April 16, 2022 |
Est. primary completion date | April 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Age = 18 years; 2. American Society of Anesthesiologists physical status I~II; 3. Scheduled to undergo elective oral and maxillofacial surgery requires nasal intubation; 4. The expected operation time < 3 hours; 5. Extubation in operation room and do not scheduled to preventive tracheotomy; 6. Patients who were able to breathe clearly and equally through both nostrils. Exclusion Criteria: 1. Patients had history of difficult intubation or presented with an anticipated difficult airway; 2. Patients requiring nasogastric tube insertion; 3. Presence of contraindications of nasal intubation; 4. Due to surgical requirement, intubation must be completed through one nostril; 5. Presence of severe nasal obstruction,deformities of the nasal cavity, or other serious nasal diseases; 6. History of severe epistaxis or epistaxis within a month; 7. Previous history of nasal and/or laryngeal surgery; 8. Previous experience with nasal intubation; 9. History of schizophrenia, Parkinson's disease or profound dementia, or language barrier; 10. Participate in other clinical studies; 11. Refusal to sign informed consent. |
Country | Name | City | State |
---|---|---|---|
China | Peking University Hospital of Stomatology | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University | Peking University Hospital of Stomatology |
China,
Boku A, Hanamoto H, Hirose Y, Kudo C, Morimoto Y, Sugimura M, Niwa H. Which nostril should be used for nasotracheal intubation: the right or left? A randomized clinical trial. J Clin Anesth. 2014 Aug;26(5):390-4. doi: 10.1016/j.jclinane.2014.01.016. Epub 2014 Aug 10. — View Citation
Cheng T, Wang LK, Wu HY, Yang XD, Zhang X, Jiao L. Shikani Optical Stylet for Awake Nasal Intubation in Patients Undergoing Head and Neck Surgery. Laryngoscope. 2021 Feb;131(2):319-325. doi: 10.1002/lary.28763. Epub 2020 Jun 10. — View Citation
Tan YL, Wu ZH, Zhao BJ, Ni YH, Dong YC. For nasotracheal intubation, which nostril results in less epistaxis: right or left?: A systematic review and meta-analysis. Eur J Anaesthesiol. 2021 Nov 1;38(11):1180-1186. doi: 10.1097/EJA.0000000000001462. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Intubation related adverse events. | Safety outcome | Up to 24 hours after intubation. | |
Primary | Total time for intubation | The duration from when the device tip entered the nostril to when the tube entered the trachea, as confirmed by capnography. | Procedure (From when the device tip entered the nostril to when the tube entered the trachea.) | |
Secondary | Total success rate | Total success rate of nasal intubation with video rigid stylet. | Procedure (Up to the tube entered the trachea.) | |
Secondary | First-attempt success | First-attempt success of nasal intubation with video rigid stylet. | First-attempt of nasal intubation with video rigid stylet. | |
Secondary | Times of intubation-attempts | Times of intubation-attempts. | Procedure (From when the device tip entered the nostril to when the tube entered the trachea.) | |
Secondary | The time for device insertion | The duration from when the device tip entered the nostril to when it passed through the vocal cord. | Procedure (From when the device tip entered the nostril to when it passed through the vocal cord.) | |
Secondary | The time for tube insertion | The duration from when the tip of the device passed through the vocal cord to when the tube was confirmed inserted into the trachea. | Procedure (From when the tip of the device passed through the vocal cord to when the tube was confirmed inserted into the trachea.) | |
Secondary | Incidence and severity of epistaxis | Incidence and severity of epistaxis | Procedure (Up to completion of intubation) |
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