For Nasotracheal Intubation With Video Rigid Stylet, Which Nostril is Better?

Not Applicable

Completed

• Conditions: Intubation; Video Rigid Stylet

• Registration Number: NCT05218590
• Lead Sponsor: Peking University

Brief Summary

To determine which nostril is more suitable for nasotracheal intubation with video rigid stylet.

Detailed Description

Head and neck surgeries usually require nasal intubation, which allows leeway for operative maneuvering in the mouth, pharynx, larynx, and neck. Previous studies have found that the right nostril is more appropriate for nasal intubation using direct laryngoscope or videolaryngoscope. It has been shown that the optical rigid stylet was also an appropriate tool for nasal intubation. However, nasal intubation with rigid optical stylet is technically different from that with laryngoscope. It is unknown whether the choice of nostril could affect the intubation using rigid optical stylet. The main aim is to determine which nostril is more suitable for nasal intubation with video rigid stylet.

Study Timeline

• Study First Submitted: 2022-01-30
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-01
• Study Start: 2022-02-08
• Status Verified: 2022-04
• Primary Completion: 2022-04-15
• Study Completion: 2022-04-16
• Last Update Submitted: 2022-04-27
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total time for intubation	Procedure (From when the device tip entered the nostril to when the tube entered the trachea.)	The duration from when the device tip entered the nostril to when the tube entered the trachea, as confirmed by capnography.

Secondary Outcome Measures

Name	Time	Method
Total success rate	Procedure (Up to the tube entered the trachea.)	Total success rate of nasal intubation with video rigid stylet.
First-attempt success	First-attempt of nasal intubation with video rigid stylet.	First-attempt success of nasal intubation with video rigid stylet.
Times of intubation-attempts	Procedure (From when the device tip entered the nostril to when the tube entered the trachea.)	Times of intubation-attempts.
The time for device insertion	Procedure (From when the device tip entered the nostril to when it passed through the vocal cord.)	The duration from when the device tip entered the nostril to when it passed through the vocal cord.
The time for tube insertion	Procedure (From when the tip of the device passed through the vocal cord to when the tube was confirmed inserted into the trachea.)	The duration from when the tip of the device passed through the vocal cord to when the tube was confirmed inserted into the trachea.
Incidence and severity of epistaxis	Procedure (Up to completion of intubation)	Incidence and severity of epistaxis

Trial Locations

Locations (1)

Peking University Hospital of Stomatology; 🇨🇳 Beijing, China