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

NCT04479839 | Completed DMC

• 1 other identifier: 1570971
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Endotracheal Tube; Cricoid Cartilage; Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Microcuff ETT

Patients intubated with microcuff ETT

Diagnostic Test: Ultrasound of the airway

Non-microcuff ett

Patients intubated with regular ETT

Diagnostic Test: Ultrasound of the airway

Interventions

Ultrasound of the airway DIAGNOSTIC_TEST

Placing ultrasound on the neck after intubation

Microcuff ETT; Non-microcuff ett

Eligibility Criteria

• Age: 1 Day - 71 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients undergoing general anesthesia requiring endotracheal intubation

You may not qualify if:

• Patients with any anatomical airway deformity or mass

Sponsors & Collaborators

• Sidra Medicine: lead

Study Sites (1)

Sidra Medicine

Doha, 0000, Qatar

Location

Study Officials

• Tariq Wani

  Attending physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior attending

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 21, 2020
• Study Start: June 15, 2020
• Primary Completion: September 10, 2020
• Study Completion: September 10, 2020
• Last Updated: July 9, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)