Point of Care Ultrasound to Confirm Endotracheal Tube Cuff Position in Relationship to the Cricoid in Pediatric Population.

Completed

• Conditions: Endotracheal Tube; Ultrasound; Cricoid Cartilage
• Interventions: Diagnostic Test: Ultrasound of the airway

• Registration Number: NCT04479839
• Lead Sponsor: Sidra Medicine

Brief Summary

Anatomically, the infra-glottic area (subglottis) and the cricoid ring are the narrowest part of the larynx. In order to limit the incidence of damage related to mucosal pressure injuries from the presence of an endotracheal tube (ETT), the cuff of the ETT should lie below the cricoid in children. Previously, no clinical or imaging method has been used in real time at the bedside to determine the exact location of the ETT cuff after endotracheal intubation. Point-of-care ultrasound (POCUS) may provide an option for a safe and rapid means of visualizing the cuff of the ETT and its relationship to the cricoid ring in real-time thereby allowing ideal ETT positioning.

Detailed Description

Airway below vocal cords until the distal end of the cricoid referred to as subglottis or infraglottis is considered to be the narrowest part of the airway. An optimal endotracheal tube (ETT) placement with cuffed ETT is to ensure the cuff position below the cricoid ring (cuff free glottis): as well have sufficient distance between ETT tip and carina. Various modalities including clinical examination, ETCO2, imaging (X-ray and ultrasound) are routinely used to verify the position and the tip of the ETT in the airway, however verification of the cuff position remains obscure.

Study Timeline

• Study Start: 2020-06-15
• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-16
• Study First Posted: 2020-07-21
• Primary Completion: 2020-09-10
• Study Completion: 2020-09-10
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-08
• Last Update Posted: 2021-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients undergoing general anesthesia requiring endotracheal intubation

Exclusion Criteria

• Patients with any anatomical airway deformity or mass

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Microcuff ETT	Ultrasound of the airway	Patients intubated with microcuff ETT
Non-microcuff ett	Ultrasound of the airway	Patients intubated with regular ETT

Primary Outcome Measures

Name	Time	Method
Visualize the saline-filled cuff of the endotracheal tube	3 months	The primary objective was to visualize the saline-filled cuff of the endotracheal tube in relation to the cricoid and tracheal rings

Trial Locations

Locations (1)

Sidra Medicine; 🇶🇦 Doha, Qatar