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

NCT06985108 | Completed

• 1 other identifier: 171/2025
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epistaxis

Keywords

nazotracheal intubation; north polar tube; epistaxis; spiral tube

Outcome Measures

Primary Outcomes (2)

• 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.

  perioperative period

• 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.

  perioperative period

Secondary Outcomes (2)

• intubation duration

  perioperative

• intubation difficulty

  perioperative

Study Arms (2)

north polar tube

ACTIVE COMPARATOR

patients who intubated with north polar tube

Procedure: nazotracheal intubation

spiral tube

ACTIVE COMPARATOR

patients who intubated with spiral tube

Procedure: nazotracheal intubation

Interventions

nazotracheal intubation PROCEDURE

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

north polar tube; spiral tube

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dicle University: lead

Study Sites (1)

Dicle university Faculty of dentistry

Diyarbakır, Turkey (Türkiye)

Location

Related Links

• Latest publication about similar work-up

MeSH Terms

Conditions

Epistaxis

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Fikret Salik, specialist

  Dicle university faculty of medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medicine doctor anesthesiology specialist

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 22, 2025
• Study Start: May 2, 2025
• Primary Completion: August 30, 2025
• Study Completion: October 30, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 3 months after publication of results
• Access Criteria: medicine doctors, dentists

Locations

TU (1)