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NCT04479839 Clinical Trial

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

Ultrasound Clinical Trial

Official title:
Senior Atending Anesthesiologist

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04479839
Other study ID # 1570971
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 15, 2020
Est. completion date September 10, 2020

Study information
Verified date July 2021
Source Sidra Medical and Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date September 10, 2020
Est. primary completion date September 10, 2020
Accepts healthy volunteers
Gender All
Age group N/A to 71 Months
Eligibility Inclusion Criteria: - Patients undergoing general anesthesia requiring endotracheal intubation Exclusion Criteria: - Patients with any anatomical airway deformity or mass

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Ultrasound of the airway
Placing ultrasound on the neck after intubation

Locations
Country Name City State
Qatar Sidra Medicine Doha

Sponsors (1)
Lead Sponsor Collaborator
Sidra Medical and Research Center

Country where clinical trial is conducted

Qatar, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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