Comparison of First Attempt Success in Nasotracheal Intubation Using Macintosh Videolaryngoscope vs. Flexible Bronchoscope
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Macintosh videolaryngoscope, Flexible bronchoscope.
- Who it may be relevant to
- Registry conditions: Intubation Complication. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of First Attempt Success in Nasotracheal Intubation Using Macintosh Videolaryngoscope vs. Flexible Bronchoscope: a Randomized Controlled Trial
Overview
Participants are randomly assigned to two groups: one group undergoes nasotracheal intubation using a videolaryngoscope, while the other group undergoes nasotracheal intubation using a flexible bronchoscope. The primary outcome is the first-attempt success rate, assessed at the time of tracheal tube placement. Additional outcomes include the degree of subglottic injury upon extubation, and the incidence and severity of sore throat and hoarseness at 1 hour and 24 hours postoperatively, as well as overall intubation success rates.
Interventions
- Device Macintosh videolaryngoscope
Used to perform nasotracheal intubation under general anesthesia. The Macintosh videolaryngoscope is introduced orally to visualize the glottis, and a preformed nasotracheal tube is inserted through the nostril. - Device Flexible bronchoscope
Used to perform nasotracheal intubation under general anesthesia. The bronchoscope is inserted through a lubricated nasotracheal tube and advanced into the trachea.
Primary outcome measures
- First-attempt success rate of nasotracheal intubation [Time frame: At the time of tracheal intubation]
Secondary outcome measures (9)
- Degree of subglottic injury [Time frame: At the time of extubation]
- Postoperative sore throat severity [Time frame: 1 hour and 24 hours postoperatively]
- Incidence of postoperative hoarseness [Time frame: 1 hour and 24 hours postoperatively]
- Cormack-Lehane grade [Time frame: At the time of tracheal intubation]
- Changes in blood pressure [Time frame: Within 5 minutes before and after intubation]
- POGO score [Time frame: At the time of tracheal intubation]
- Changes in heart rate [Time frame: Within 5 minutes before and after intubation]
- Changes in saturation [Time frame: Within 5 minutes before and after intubation]
- Changes in bispectral value [Time frame: Within 5 minutes before and after intubation]
Eligibility criteria
Inclusion criteria
- Adults aged 19 years or older
- Undergoing ear, nose, and throat (ENT) surgery requiring nasotracheal intubation
Exclusion criteria
- Refusal to participate in the study
- History of gastroesophageal reflux disease
- History of surgery or radiation therapy involving the upper airway
- Presence of severely loose teeth
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
Identifiers
NCT: NCT06964295 · 2503-041-1621