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CompletedNCT06985108Updated Feb 10, 2026

Comparison of Nasal Endotracheal Tube and Spiral Tube for Nasotracheal Intubation in Pediatric Patients

An interventional study of nazotracheal intubation in Epistaxis, sponsored by Dicle University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-02-10.

Sponsored by Dicle University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
98
Allocation
Randomized
Ages
3 Years to 18 Years
Sex
All
01

Study summary

Nasotracheal intubation is often preferred in patients under general anesthesia for maxillofacial surgery or dental treatment to ensure airway safety and to work more comfortably in the surgical field. Compared to orotracheal intubation, the nasotracheal approach is a more convenient option, especially during procedures whose surgical site is in the oral region.

Standard spiral intubation tubes are commonly used for nasotracheal intubation. However, there are also pre-shaped nasal intubation tubes that are specially designed to better fit the nasopharyngeal anatomical structure. The North Polar Tube, one of the most prominent of these tubes, is preferred because it is easier to insert through the nasal route and reduces potential trauma.

In our hospital, nasal intubation is routinely preferred in pediatric patients under general anesthesia for dental procedures. However, there are not enough comparative studies in the literature on the advantages and disadvantages of different intubation tubes used in these applications, especially in the pediatric age group.

In our hospital, nasal intubation is routinely performed in pediatric patients undergoing general anesthesia for dental treatments. In this study, the investigators will compare the spiral intubation tube and nasotracheal intubation tube used for intubation of these patients in terms of epistaxis, intubation time and difficulty of intubation.

Read the detailed description

During our study, 96 patients between the ages of 3-18 years with appropriate criteria between 01.05.2025-01.08.2025 will be recruited for general anesthesia.

Patients will be taken to the operating room and after routine monitoring methods (SpO2, Pulse, Non invasive blood pressure) are used and data are recorded, 1 mg/kg midazolam, 1 mg/kg lidocaine, 2 mcg/kg fentanyl, 2-3 mg/kg propofol and 0.6-1.2 mg/kg rocuronium will be administered intravenously. Before intubation, patients will be randomly distributed into groups by closed envelope method (Group 1: NPT, Group 2: Spiral Tube) and intubation will be performed using nasal intubation tube or spiral tube. The procedures performed are daily routine procedures and no new procedure will be performed on the patient.

Vital measurements at the 1st and 5th minutes after intubation will be recorded. Anesthesia maintenance will be provided with 2-3% sevoflurane 50% oxygen 50% air mixture.

After intubation, the presence and severity of epistaxis, if any; presence of intra-oral bleeding, use of Magill forceps, duration of intubation, difficulty of intubation (number of intubation attempts, need for video laryngoscope use), whether laryngeal compression (Sellick maneuver) was applied and glottic degree (Cormack-Lehane classification) data will be recorded. When nasotracheal intubation cannot be performed, orotracheal intubation will be performed and patients will be excluded from the study.

Inclusion Criteria; Being between 3-18 years old

  • No anomaly preventing nasal intubation
  • To be in ASA1-2 classification according to ASA criteria

Exclusion Criteria;

  • Lack of consent of the patient/ relatives
  • Facial anomaly that prevents nasal intubation
  • Being in the ASA3-4 group according to ASA criteria
02

Conditions studied

  • Epistaxis

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Keywords

  • nazotracheal intubation
  • north polar tube
  • epistaxis
  • spiral tube
03

Who can participate

Ages eligible
3 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Being between 3-18 years old
  • No anomaly preventing nasal intubation
  • To be in ASA1-2 classification according to ASA criteria

Exclusion criteria

Exclusion Criteria:

  • Lack of consent of the patient/ relatives
  • Facial anomaly that prevents nasal intubation
  • Being in the ASA3-4 group according to ASA criteria
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
98 participants (actual)

Study arms

  • Active comparator
    north polar tube

    patients who intubated with north polar tube

    Procedure: nazotracheal intubation

  • Active comparator
    spiral tube

    patients who intubated with spiral tube

    Procedure: nazotracheal intubation

Interventions

  • Procedurenazotracheal intubation

    intubation tube will be placed from nasal orifice through nazopharyngeal pathway to place into trachea

05

What researchers measure

Primary outcomes

  1. epistaxis frequency

    epistaxis presence will be controlled at 0. minute and 5. minute after intubation. Epistaxis occurancy will be noted as present/absent. More incidence of epistaxis will be related to worse outcome.

    Time frame: perioperative period

  2. severity of epistaxis

    epistaxis severity will be measured at 0.and 5. minute after intubation. Severity will be classified as; none:no blood observed on either the surface of the tube or the posterior pharyngeal wall mild:blood apparent on the surface of the tube or posterior pharyngeal wall moderate: pooling of blood on the posterior pharyngeal wall severe: large amount of blood in the pharynx impeding nasotracheal intubation and necessitating urgent orotracheal intubation The outcome gets worse as it goes from none to severe.

    Time frame: perioperative period

Secondary outcomes

  1. intubation duration

    intubation duration will be noted in seconds and there is predicted minimum and maximum values. Prolonged intubation time is related to worse outcome.

    Time frame: perioperative

  2. intubation difficulty

    To assessment of intubation difficulty; number of attempts, Cormack lehane score, usage of Magill forceps, usage of Video laryngoscope and need to Sellick maneuver will be noted. Higher number of attempts will indicate worse outcome. Other evaluations will be in a yes/no format. İf the yes rate be higher than the no rate outcome will be accepted as worse

    Time frame: perioperative

06

Study locations

1 site
  • Dicle university Faculty of dentistry
    Diyarbakır, Turkey (Türkiye)
07

References and documents

Study documents

  • Protocol, analysis plan and consent form · May 6, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — all collected IDP

Supporting information: Study protocol

08

Registry details

Key details

Study ID
NCT06985108
Lead sponsor
Dicle University
Responsible party
Zülfü SAVAŞ (medicine doctor anesthesiology specialist, Dicle University) — Principal investigator
First posted
May 22, 2025
Start date
May 2, 2025
Primary completion
Aug 30, 2025
Completion
Oct 30, 2025
Last update
Feb 10, 2026

Study contacts

Fikret Salik, specialist
study director · Dicle university faculty of medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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