Guidewire Use in Nasotracheal Intubation

Epistaxis Nosebleed Clinical Trial

Official title:

Guidewire Use for Nasopharyngeal Passage in Pediatric Nasotracheal Intubation: A Randomized Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05937516
• Other study ID #: a.esen001
• Status: Completed
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: April 20, 2023

Study information

• Verified date: July 2023
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 20, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Epistaxis
• Epistaxis Nosebleed
• Hemorrhage

Intervention

Device:
• Nasotracheal intubation with conventionally
Nasotracheal intubation will be applied conventionally to patients in this group.
• 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.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University, Faculty of Medicine	Fatih	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of blood in oropharynx or on the endotracheal tube	The presence of blood in the oropharynx or endotracheal tube will be defined by assessing it on a scale. (0 = no blood, 2 = mild, that is, dye-like blood on the endotracheal tube, 3 = severe, that is, obvious blood in the oropharynx).	In the first minute after intubation
Primary	Presence of blood in oropharynx or on the endotracheal tube	The presence of blood in the oropharynx or endotracheal tube will be defined by assessing it on a scale. (0 = no blood, 2 = mild, that is, dye-like blood on the endotracheal tube, 3 = severe, that is, obvious blood in the oropharynx).	In the fifth minute after intubation