Nasotracheal Tube Stenting by Nelaton Catheter in Pediatric Dental Surgery

Nasotracheal Tube Stenting by Nelaton Catheter in Pediatric Dental Surgery , Prospective Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia Intubation Complication
• Intervention / Treatment: Device: Endotracheal tube; Device: Nelaton catheter

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Ain Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 9 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group I; Endotracheal tube plus Nelaton catheter	Device: Endotracheal tube; Nasotracheal intubation will be done with endotracheal tube; Device: Nelaton catheter; plus nelaton catheter; Other Names: Stent
ACTIVE_COMPARATOR: Group II; Endotracheal tube	Device: Endotracheal tube; Nasotracheal intubation will be done with endotracheal tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence and severity of Epistaxis	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.	immediately after nasotracheal intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histopathology of the endotracheal tube contents 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 .	immediately after extubation

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 10, 2018
• Primary Completion (ACTUAL): July 1, 2018
• Study Completion (ACTUAL): August 1, 2018

Study Registration Dates

• First Submitted: February 24, 2018
• First Submitted That Met QC Criteria: March 6, 2018
• First Posted (ACTUAL): March 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: FAMSU R 6 / 2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No