Guidewire Use in Nasotracheal Intubation

• ClinicalTrials.gov Identifier: NCT05937516
• Recruitment Status: Completed
• First Posted: July 10, 2023
• Last Update Posted: July 10, 2023
• Sponsor: Bezmialem Vakif University
• Information provided by (Responsible Party): Asım Esen, Bezmialem Vakif University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Epistaxis Nosebleed; Pharyngeal Bleeding	Device: Nasotracheal intubation with conventionally; Device: Nasotracheal intubation with angled ETT using guidewire	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: After intubation was completed, bleeding was evaluated by the other investigator who did not know the patient's group.
• Primary Purpose: Diagnostic
• Official Title: Guidewire Use for Nasopharyngeal Passage in Pediatric Nasotracheal Intubation: A Randomized Prospective Study
• Actual Study Start Date: March 15, 2023
• Actual Primary Completion Date: April 20, 2023
• Actual Study Completion Date: April 20, 2023

Arms and Interventions

Arm	Intervention/treatment
Sham Comparator: Control Group; Nasotracheal intubation will be applied conventionally to patients in this group.	Device: Nasotracheal intubation with conventionally; Nasotracheal intubation will be applied conventionally to patients in this group.
Active Comparator: 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.	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.

Outcome Measures

Primary Outcome Measures :

1. Presence of blood in oropharynx or on the endotracheal tube [ Time Frame: In the first minute after intubation ]
   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).
2. Presence of blood in oropharynx or on the endotracheal tube [ Time Frame: In the fifth minute after intubation ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 2 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Turkey

Bezmialem Vakif University, Faculty of Medicine

Fatih, Istanbul, Turkey, 34093

Sponsors and Collaborators

Bezmialem Vakif University

Investigators

• Principal Investigator: asim esen, Asst Prof; Bezmialem Vakif University, Faculty of Medicine

More Information

• Responsible Party: Asım Esen, Assistant Professor ASIM ESEN, Bezmialem Vakif University
• ClinicalTrials.gov Identifier: NCT05937516
• Other Study ID Numbers: a.esen001
• First Posted: July 10, 2023
• Last Update Posted: July 10, 2023
• Last Verified: July 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Asım Esen, Bezmialem Vakif University:

Airway management; Intubation complication; Nasotracheal intubation; Nasal bleeding

Additional relevant MeSH terms:

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