Guidewire Use in Nasotracheal Intubation

NCT ID: NCT05937516

Last Updated: 2023-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2023-04-20

Brief Summary

During nasotracheal intubation, nasopharyngeal trauma and associated bleeding may occur. The investigators think that some of this bleeding is due to trauma to the posterior wall of the nasopharynx. The investigators designed this study, thinking that if nasopharyngeal posterior wall trauma can be prevented, some of these bleedings can be prevented.

Detailed Description

Nasotracheal intubation (NTI) is a frequently used airway management method in pedodontic dental treatments performed under general anesthesia. However, nasopharyngeal trauma and associated bleeding are common during conventional NTI. In this study, the investigators aimed to examine the effect of angling the end of the endotracheal tube (ETT) by placing a guide wire inside the ETT on nasopharyngeal bleeding.

The patients included in the study were randomized into two groups. In the control group (Group C), NTI will be done conventionally. In the study group (Group S), a guide wire will be inserted into the ETT before intubation and angled 100-120 degrees to the distal end (in the shape of a hockey stick). The angulation will not be sharp but slightly curved and the apex of the angulation will be 2.5-3 cm proximal from the distal end. The ETT will be positioned perpendicular to the face and inserted into the nostril. After the angled part of the ETT passes through the nostrils, it will be directed to caudally according to the angle given to the tip of the ETT. Meanwhile, the ETT will be moved as a whole to prevent the ETT tip from contacting the posterior wall of the nasopharynx. When the ETT tip reaches the oropharynx, the guidewire will be removed and the rest of the intubation will be completed as in the conventional method.

Conditions

Epistaxis Nosebleed; Pharyngeal Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Control Group

Nasotracheal intubation will be applied conventionally to patients in this group.

Group Type: SHAM_COMPARATOR

Nasotracheal intubation with conventionally

Intervention Type: DEVICE

Nasotracheal intubation will be applied conventionally to patients in this group.

Study Group

In the study group (Group S), a guide wire will be inserted into the ETT before intubation and angled 100-120 degrees to the distal end (in the shape of a hockey stick). The angulation will not be sharp but slightly curved and the apex of the angulation will be 2.5-3 cm proximal from the distal end. The ETT will be positioned perpendicular to the face and inserted into the nostril. After the angled part of the ETT passes through the nostrils, it will be directed to caudally according to the angle given to the tip of the ETT. Meanwhile, the ETT will be moved as a whole to prevent the ETT tip from contacting the posterior wall of the nasopharynx. When the ETT tip reaches the oropharynx, the guidewire will be removed and the rest of the intubation will be completed as in the conventional method.

Group Type: ACTIVE_COMPARATOR

Nasotracheal intubation with angled ETT using guidewire

Intervention Type: DEVICE

a guide wire will be inserted into the ETT before intubation and angled 100-120 degrees to the distal end (in the shape of a hockey stick). The angulation will not be sharp but slightly curved and the apex of the angulation will be 2.5-3 cm proximal from the distal end. The ETT will be positioned perpendicular to the face and inserted into the nostril. After the angled part of the ETT passes through the nostrils, it will be directed to caudally according to the angle given to the tip of the ETT. Meanwhile, the ETT will be moved as a whole to prevent the ETT tip from contacting the posterior wall of the nasopharynx. When the ETT tip reaches the oropharynx, the guidewire will be removed and the rest of the intubation will be completed as in the conventional method.

Interventions

Nasotracheal intubation with conventionally

Nasotracheal intubation will be applied conventionally to patients in this group.

Intervention Type: DEVICE

Nasotracheal intubation with angled ETT using guidewire

a guide wire will be inserted into the ETT before intubation and angled 100-120 degrees to the distal end (in the shape of a hockey stick). The angulation will not be sharp but slightly curved and the apex of the angulation will be 2.5-3 cm proximal from the distal end. The ETT will be positioned perpendicular to the face and inserted into the nostril. After the angled part of the ETT passes through the nostrils, it will be directed to caudally according to the angle given to the tip of the ETT. Meanwhile, the ETT will be moved as a whole to prevent the ETT tip from contacting the posterior wall of the nasopharynx. When the ETT tip reaches the oropharynx, the guidewire will be removed and the rest of the intubation will be completed as in the conventional method.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 2-12 years old
• American Society of Anesthesiologists I-III
• Patients with elective dental surgery
• Patients whose parents have accepted informed consent forms
• Patients without previous nasopharyngeal anomalies
• Patients without previous nasopharyngeal surgeries
• Patients without upper airway infections

Exclusion Criteria

• Under 2 or over 12 years old
• Emergency surgeries
• Patients whose parents have not accepted informed consent forms
• Patients with previous nasopharyngeal anomalies
• Patients with previous nasopharyngeal surgeries
• Patients with upper airway infections

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Asım Esen

Assistant Professor ASIM ESEN

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

asim esen, Asst Prof

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University, Faculty of Medicine

Locations

Bezmialem Vakif University, Faculty of Medicine

Fatih, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

a.esen001

Identifier Type: -

Identifier Source: org_study_id