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Nasotracheal Tube Stenting by Nelaton Catheter in Pediatric Dental Surgery

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ClinicalTrials.gov Identifier: NCT03462732
Recruitment Status : Active, not recruiting
First Posted : March 13, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Amin Mohammed Alansary Amin Ahmed Helwa, 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.

Condition or disease Intervention/treatment Phase
Anesthesia Intubation Complication Device: Endotracheal tube Device: Nelaton catheter Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Nasotracheal Tube Stenting by Nelaton Catheter in Pediatric Dental Surgery , Prospective Randomized Clinical Trial
Actual Study Start Date : February 10, 2018
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : August 2018

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 Name: Stent

Active Comparator: Group II
Endotracheal tube
Device: Endotracheal tube
Nasotracheal intubation will be done with endotracheal tube




Primary Outcome Measures :
  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 Outcome Measures :
  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 .



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Ages Eligible for Study:   3 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03462732


Locations
Egypt
Ain Shams University hospitals
Cairo, Egypt, 11591
Sponsors and Collaborators
Ain Shams University

Responsible Party: Amin Mohammed Alansary Amin Ahmed Helwa, Assistant Professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT03462732     History of Changes
Other Study ID Numbers: FAMSU R 6 / 2018
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No