US Prediction of Actual Tube Size and Performance Characteristics of Pediatric Cuffed Vs Un-Cuffed ETT.

NCT03560895 | Completed DMC

• 1 other identifier: 17200201
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study will be to test the accuracy of Sonography in determining the endotracheal tube size in pediatric patients whether cuffed or un-cuffed.

Conditions

Airway Complication of Anesthesia

Outcome Measures

Primary Outcomes (1)

• The rate of agreement between the reference tube size based on sonographic measurements and the final BEST-FIT ETT

  The rate of agreement between the reference tube size based on sonographic measurements and the final BEST-FIT ETT

  AT induction of anesthesia

Study Arms (2)

Group I

Patients will be anesthetized using high-volume low-pressure cuffed endotracheal tube (Flexicare-UK) ) with its outer diameter determined by ultrasonography.

Device: cuffed endotracheal tube

Group II

Patients will be anesthetized using uncuffed endotracheal tube (Flexicare-UK) with its outer diameter determined by ultrasonography.

Device: Uncuffed endotracheal tube

Interventions

cuffed endotracheal tube DEVICE

Patients will be anesthetized using high-volume low-pressure cuffed endotracheal tube

Also known as: C ETT

Group I

Uncuffed endotracheal tube DEVICE

Patients will be anesthetized using uncuffed endotracheal tube

Also known as: ETT

Group II

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 1-6 years of both sexes undergoing surgical procedures in which an endotracheal tube is needed.

You may qualify if:

• Weight: 10-30 kg.
• Age: 1-6 years.
• Sex: both males and females.
• ASA physical status: I-II.
• Operation: elective surgery in which airway management with an endotracheal tube is needed.

You may not qualify if:

• Upper airway malformations.
• Upper airway surgery.
• Active respiratory illness (cough, fever, rhinorrhea) on the day of anesthesia,
• Anticipated difficult airway.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Pediatric hospital, faculty of medicine, Assiut university

Asyut, Assiut Governorate, 715715, Egypt

Location

Study Officials

• Hala S Abdelghaffar, MD

  Professor of anesthesia, faculty of medicine, Assiut university, Egypt.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of anesthesia and intensive care, faculty of medicine, Assiut university.

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 18, 2018
• Study Start: June 25, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)