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Completed

NCT Number: NCT05218590

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Hospital of Stomatology

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • Refusal to sign informed consent.

Treatment and study plan

Video rigid stylet

Device

Nasal intubation was performed using the video rigid stylet.

Primary outcomes

  1. 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

  1. Total success rate

    Time frame: Procedure (Up to the tube entered the trachea.)

    Total success rate of nasal intubation with video rigid stylet.

  2. First-attempt success

    Time frame: First-attempt of nasal intubation with video rigid stylet.

    First-attempt success of nasal intubation with video rigid stylet.

  3. Times of intubation-attempts

    Time frame: Procedure (From when the device tip entered the nostril to when the tube entered the trachea.)

    Times of intubation-attempts.

  4. The time for device insertion

    Time frame: 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.

  5. The time for tube insertion

    Time frame: 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.

  6. Incidence and severity of epistaxis

    Time frame: Procedure (Up to completion of intubation)

    Incidence and severity of epistaxis

Other outcomes

  1. Intubation related adverse events.

    Time frame: Up to 24 hours after intubation.

    Safety outcome

Sponsors and collaborators

Lead sponsor

Peking University

Other

Collaborators

  • Peking University Hospital of Stomatology

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 1, 2022
Registry last updated
Apr 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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