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Guidewire Use in Nasotracheal Intubation

Primary Purpose

Epistaxis Nosebleed, Pharyngeal Bleeding

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Nasotracheal intubation with conventionally
Nasotracheal intubation with angled ETT using guidewire
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epistaxis Nosebleed focused on measuring Airway management, Intubation complication, Nasotracheal intubation, Nasal bleeding

Eligibility Criteria

2 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bezmialem Vakif University, Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Control Group

Study Group

Arm Description

Nasotracheal intubation will be applied conventionally to patients in this 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.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

Full Information

First Posted
June 20, 2023
Last Updated
July 6, 2023
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT05937516
Brief Title
Guidewire Use in Nasotracheal Intubation
Official Title
Guidewire Use for Nasopharyngeal Passage in Pediatric Nasotracheal Intubation: A Randomized Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
April 20, 2023 (Actual)
Study Completion Date
April 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epistaxis Nosebleed, Pharyngeal Bleeding
Keywords
Airway management, Intubation complication, Nasotracheal intubation, Nasal bleeding

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
After intubation was completed, bleeding was evaluated by the other investigator who did not know the patient's group.
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Nasotracheal intubation will be applied conventionally to patients in this group.
Arm Title
Study Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Nasotracheal intubation with conventionally
Intervention Description
Nasotracheal intubation will be applied conventionally to patients in this group.
Intervention Type
Device
Intervention Name(s)
Nasotracheal intubation with angled ETT using guidewire
Intervention Description
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.
Primary Outcome Measure Information:
Title
Presence of blood in oropharynx or on the endotracheal tube
Description
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).
Time Frame
In the first minute after intubation
Title
Presence of blood in oropharynx or on the endotracheal tube
Description
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).
Time Frame
In the fifth minute after intubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
asim esen, Asst Prof
Organizational Affiliation
Bezmialem Vakif University, Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem Vakif University, Faculty of Medicine
City
Fatih
State/Province
Istanbul
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

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Guidewire Use in Nasotracheal Intubation

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