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Clinical Trials/NCT05218590
NCT05218590
Completed
Not Applicable

For Nasotracheal Intubation With Video Rigid Stylet, Which Nostril is Better? A Randomized Clinical Trial

Peking University1 site in 1 country50 target enrollmentFebruary 8, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intubation
Sponsor
Peking University
Enrollment
50
Locations
1
Primary Endpoint
Total time for intubation
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 8, 2022
End Date
April 16, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Peking University
Responsible Party
Principal Investigator
Principal Investigator

Yang Xudong

Project leader

Peking University

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years;
  • American Society of Anesthesiologists physical status I\~II;
  • Scheduled to undergo elective oral and maxillofacial surgery requires nasal intubation;
  • The expected operation time \< 3 hours;
  • Extubation in operation room and do not scheduled to preventive tracheotomy;
  • Patients who were able to breathe clearly and equally through both nostrils.

Exclusion Criteria

  • Patients had history of difficult intubation or presented with an anticipated difficult airway;
  • Patients requiring nasogastric tube insertion;
  • Presence of contraindications of nasal intubation;
  • Due to surgical requirement, intubation must be completed through one nostril;
  • Presence of severe nasal obstruction,deformities of the nasal cavity, or other serious nasal diseases;
  • History of severe epistaxis or epistaxis within a month;
  • Previous history of nasal and/or laryngeal surgery;
  • Previous experience with nasal intubation;
  • History of schizophrenia, Parkinson's disease or profound dementia, or language barrier;
  • Participate in other clinical studies;

Outcomes

Primary Outcomes

Total time for intubation

Time Frame: 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 Outcomes

  • Total success rate(Procedure (Up to the tube entered the trachea.))
  • First-attempt success(First-attempt 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.))
  • The time for device insertion(Procedure (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.))
  • Incidence and severity of epistaxis(Procedure (Up to completion of intubation))

Study Sites (1)

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