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

Senior Atending Anesthesiologist

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.

Study Overview

• Status: Completed
• Conditions: Endotracheal Tube; Cricoid Cartilage; Ultrasound
• Intervention / Treatment: Diagnostic test: Ultrasound of the airway

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Qatar
  • Doha, Qatar, 0000
    • Sidra Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

80 children from birth to 7 years, scheduled for the surgery requiring endotracheal intubation

Description

Inclusion Criteria:

• Patients undergoing general anesthesia requiring endotracheal intubation

Exclusion Criteria:

• Patients with any anatomical airway deformity or mass

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Microcuff ETT; Patients intubated with microcuff ETT	Diagnostic test: Ultrasound of the airway; Placing ultrasound on the neck after intubation
Non-microcuff ett; Patients intubated with regular ETT	Diagnostic test: Ultrasound of the airway; Placing ultrasound on the neck after intubation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sidra Medical and Research Center
• Investigators: Principal Investigator: Tariq Wani, Attending Physician

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2020
• Primary Completion (Actual): September 10, 2020
• Study Completion (Actual): September 10, 2020

Study Registration Dates

• First Submitted: July 16, 2020
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (Actual): July 21, 2020

Study Record Updates

• Last Update Posted (Actual): July 9, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 1570971

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No