Nasotracheal Tube Stenting by Nelaton Catheter in Pediatric Dental Surgery
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 10, 2018
CompletedFirst Submitted
Initial submission to the registry
February 24, 2018
CompletedFirst Posted
Study publicly available on registry
March 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedMay 19, 2020
May 1, 2020
5 months
February 24, 2018
May 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Histopathology of the endotracheal tube contents after extubation
immediately after extubation
Study Arms (2)
Group I
ACTIVE COMPARATOREndotracheal tube plus Nelaton catheter
Group II
ACTIVE COMPARATOREndotracheal tube
Interventions
Eligibility Criteria
You may qualify if:
- Pediatric patients scheduled for dental surgery under general anesthesia age 3-9 years
- physical status American society of Anesthesiologist(ASA) I orII
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University hospitals
Cairo, 11591, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 24, 2018
First Posted
March 13, 2018
Study Start
February 10, 2018
Primary Completion
July 1, 2018
Study Completion
August 1, 2018
Last Updated
May 19, 2020
Record last verified: 2020-05