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Nasotracheal Tube Stenting by Nelaton Catheter in Pediatric Dental Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03462732
Enrollment
80
Registered
2018-03-13
Start date
2018-02-10
Completion date
2018-08-01
Last updated
2020-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia Intubation Complication

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.

Interventions

DEVICEEndotracheal tube

Nasotracheal intubation will be done with endotracheal tube

DEVICENelaton catheter

plus nelaton catheter

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

assignment

Eligibility

Sex/Gender
ALL
Age
3 Years to 9 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
incidence and severity of Epistaxisimmediately after nasotracheal intubationAn 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

MeasureTime frameDescription
Histopathology of the endotracheal tube contents after extubationimmediately after extubationafter 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 .

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026