Guidewire Use in Nasotracheal Intubation

Sponsor

Bezmialem Vakif University (Other)

Overall Status

Completed

CT.gov ID

NCT05937516

Collaborator

(none)

Enrollment

Location

Arms

1.2

Actual Duration (Months)

76.1

Patients Per Site Per Month

Study Details

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	N/A

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

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 :

Mar 15, 2023

Actual Primary Completion Date :

Apr 20, 2023

Actual Study Completion Date :

Apr 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.

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

Presence of blood in oropharynx or on the endotracheal tube [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).
Presence of blood in oropharynx or on the endotracheal tube [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

Criteria

Ages Eligible for Study:

2 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Asım Esen, Assistant Professor ASIM ESEN, Bezmialem Vakif University

ClinicalTrials.gov Identifier:

NCT05937516

Other Study ID Numbers:

a.esen001

First Posted:

Jul 10, 2023

Last Update Posted:

Jul 10, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Asım Esen, Assistant Professor ASIM ESEN, Bezmialem Vakif University

Airway management

Intubation complication

Nasotracheal intubation

Nasal bleeding

Additional relevant MeSH terms:

Epistaxis

Hemorrhage

Study Results

No Results Posted as of Jul 10, 2023