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

NCT ID: NCT06985108

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-02
• Study Completion Date: 2025-10-30

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.

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

Conditions

Epistaxis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

north polar tube

patients who intubated with north polar tube

Group Type: ACTIVE_COMPARATOR

nazotracheal intubation

Intervention Type: PROCEDURE

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

spiral tube

patients who intubated with spiral tube

Group Type: ACTIVE_COMPARATOR

nazotracheal intubation

Intervention Type: PROCEDURE

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

Interventions

nazotracheal intubation

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dicle University

OTHER

Sponsor Role: lead

Responsible Party

Zülfü SAVAŞ

medicine doctor anesthesiology specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fikret Salik, specialist

Role: STUDY_DIRECTOR

Dicle university faculty of medicine

Locations

Dicle university Faculty of dentistry

Diyarbakır, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Zulfu SAVAS, specialist

Role: CONTACT

zulfusavas@hotmail.com

+905317013696

Facility Contacts

sema celenk, professor

Role: primary

semacelenk@gmail.com

+904122411017 ext. 3360

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Related Links

https://pubmed.ncbi.nlm.nih.gov/38548948/

Latest publication about similar work-up

Other Identifiers

171/2025

Identifier Type: -

Identifier Source: org_study_id