Nasotracheal Tube Stenting by Nelaton Catheter in Pediatric Dental Surgery

Not Applicable

Completed

• Conditions: Anesthesia Intubation Complication
• Interventions: Device: Endotracheal tube; Device: Nelaton catheter

• Registration Number: NCT03462732
• Lead Sponsor: Ain Shams University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2018-02-10
• Study First Submitted: 2018-02-24
• Study First Submitted QC: 2018-03-06
• Study First Posted: 2018-03-13
• Primary Completion: 2018-07-01
• Study Completion: 2018-08-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-18
• Last Update Posted: 2020-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	Endotracheal tube	Endotracheal tube plus Nelaton catheter
Group I	Nelaton catheter	Endotracheal tube plus Nelaton catheter
Group II	Endotracheal tube	Endotracheal tube

Primary Outcome Measures

Name	Time	Method
incidence and severity of Epistaxis	immediately after nasotracheal intubation	An independent anesthesiologist who did not observe the tube insertion will assess the incidence and severity of epistaxis using a laryngoscope immediately after tube passage through the nasal cavity , four grades to evaluate epistaxis 1- no epistaxis 2- mild epistaxis ,blood apparent on the surface of the tube 3-moderate epistaxis pooling of blood on the posterior pharyngeal wall 4- severe epistaxis , large amount of blood in the pharynx impeding nasotracheal intubation and necessitating urgent orotracheal intubation.

Secondary Outcome Measures

Name	Time	Method
Histopathology of the endotracheal tube contents after extubation	immediately after extubation	after extubation the tube contents will be collected in a 5 ml syringe by using sterile swab then tissues will be separated and will be sent for histopathology , the remnant contents will be sent for microscopy , grading the contents as follow 1- secretions only 2- secretions plus blood 3- secretions , blood plus tissues .

Trial Locations

Locations (1)

Ain Shams University hospitals; 🇪🇬 Cairo, Egypt