Guidewire Use in Nasotracheal Intubation

NCT05937516 | Completed

• 1 other identifier: a.esen001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Epistaxis Nosebleed; Pharyngeal Bleeding

Keywords

Airway management; Intubation complication; Nasotracheal intubation; Nasal bleeding

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Control Group

SHAM COMPARATOR

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

Device: Nasotracheal intubation with conventionally

Study Group

ACTIVE COMPARATOR

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.

Device: Nasotracheal intubation with angled ETT using guidewire

Interventions

Nasotracheal intubation with conventionally DEVICE

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

Control Group

Nasotracheal intubation with angled ETT using guidewire 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.

Study Group

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University, Faculty of Medicine

Fatih, Istanbul, 34093, Turkey (Türkiye)

Location

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

• asim esen, Asst Prof

  Bezmialem Vakif University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: After intubation was completed, bleeding was evaluated by the other investigator who did not know the patient's group.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor ASIM ESEN

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 10, 2023
• Study Start: March 15, 2023
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: July 10, 2023

Record last verified: 2023-07

Locations

TU (1)