Nasotracheal Tube Stenting by Nelaton Catheter in Pediatric Dental Surgery

Anesthesia Intubation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03462732
• Other study ID #: FAMSU R 6 / 2018
• Status: Completed
• Phase: N/A
• Start date: February 10, 2018
• Est. completion date: August 1, 2018

Study information

• Verified date: May 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia Intubation Complication

Intervention

Device:
• Endotracheal tube
Nasotracheal intubation will be done with endotracheal tube
• Nelaton catheter
plus nelaton catheter

Locations

Country	Name	City	State
Egypt	Ain Shams University hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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