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Completed

NCT Number: NCT03462732

Nasotracheal Tube Stenting by Nelaton Catheter in Pediatric Dental Surgery

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.

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Key information

Conditions

Anesthesia Intubation Complication

Age range

3 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University hospitals

Cairo, 11591, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endotracheal tube

Device

Nasotracheal intubation will be done with endotracheal tube

Nelaton catheter

Device

plus nelaton catheter

Other names: Stent

Primary outcomes

  1. incidence and severity of Epistaxis

    Time frame: 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 outcomes

  1. Histopathology of the endotracheal tube contents after extubation

    Time frame: 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 .

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 13, 2018
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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