Nasotracheal Tube Stenting by Nelaton Catheter in Pediatric Dental Surgery

NCT ID: NCT03462732

Last Updated: 2020-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-10

Study Completion Date

2018-08-01

Brief Summary

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The value of this study is to compare between stented endotracheal tube with nelaton catheter and non stented tube as regard nasotracheal related complications as epistaxis and nasal cavity injury.

Detailed Description

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Conditions

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Anesthesia Intubation Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

assignment
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group I

Endotracheal tube plus Nelaton catheter

Group Type ACTIVE_COMPARATOR

Endotracheal tube

Intervention Type DEVICE

Nasotracheal intubation will be done with endotracheal tube

Nelaton catheter

Intervention Type DEVICE

plus nelaton catheter

Group II

Endotracheal tube

Group Type ACTIVE_COMPARATOR

Endotracheal tube

Intervention Type DEVICE

Nasotracheal intubation will be done with endotracheal tube

Interventions

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Endotracheal tube

Nasotracheal intubation will be done with endotracheal tube

Intervention Type DEVICE

Nelaton catheter

plus nelaton catheter

Intervention Type DEVICE

Other Intervention Names

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Stent

Eligibility Criteria

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Inclusion Criteria

* Pediatric patients scheduled for dental surgery under general anesthesia age 3-9 years
* physical status American society of Anesthesiologist(ASA) I orII

Exclusion Criteria

* History of recurrent epistaxis
* Coagulopathy
* Previous nasal surgery
* History of nasal trauma
* Severe renal , hepatic or cardiovascular disease
* History of drug allergy to the drugs used in the study
Minimum Eligible Age

3 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Amin Mohammed Alansary Amin Ahmed Helwa

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FAMSU R 6 / 2018

Identifier Type: -

Identifier Source: org_study_id

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