NCT05290844

Brief Summary

Because the cricoid force in children has not been quantified, clinicians wrongly used the 'adult' force. it has been found that the use of the adult force can result in compression and distortion of the child's airway and can lead to airway obstruction and difficult intubation. Based on known measurements of the cricoid surface area in children, the theoretical forces necessary to occlude the esophageal entrance have been calculated . These forces were found to be much less than the recommended adult force and much less than the forces that distort the airway as reported previously. Based on these theoretical calculations, the current study was performed to determine the effective cricoid force for pediatric groups (group 1 and group 2).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

April 5, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

1.6 years

First QC Date

February 9, 2022

Last Update Submit

March 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Cricoid Force Necessary to occlude the Esophageal Entrance In Pediatric patients

    Measuring the cricoid force using Biased Coin Method ( ED90%) in pediatric patients from 3 years up to 14 years using digital device " the Cricometer "

    day 1

Study Arms (1)

Pediatric cricoid force

OTHER

one arm ( 3 groups)120 pediatric patients

Other: cricoid pressure

Interventions

cricoid force in pediatric patients

Pediatric cricoid force

Eligibility Criteria

Age3 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age : 3-14 years ASA 1,2 Easy Identification cricoid cartilage No contre indication of CP

You may not qualify if:

  • ASA 3, 4
  • Difficult intubation
  • Obese patients
  • Contre indication of CP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Procare Riaya Hospital

Khobar, Eastern Province, 31952, Saudi Arabia

Location

Procare Riaya Hospital

Khobar, Estern, 31952, Saudi Arabia

Location

Related Publications (1)

  • Zeidan A, Ramez Salem M, Bamadhaj M, Saifan A, Khorasani A, Mazoit JX, Sadek H, Addelaziz A, Bamadhaj N, Knezevic NN. Quantifying the Effective Cricoid Force to Occlude the Esophageal Entrance in Anesthetized and Muscle-Relaxed Children: A Videolaryngoscopy-Based Assessment. Anaesth Crit Care Pain Med. 2025 Nov 7:101674. doi: 10.1016/j.accpm.2025.101674. Online ahead of print.

MeSH Terms

Conditions

Pneumonia, Aspiration

Condition Hierarchy (Ancestors)

PneumoniaRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Kamal Abdulkhaleq, MD

    PRH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 9, 2022

First Posted

March 22, 2022

Study Start

April 5, 2022

Primary Completion

October 30, 2023

Study Completion

October 31, 2023

Last Updated

March 8, 2024

Record last verified: 2024-03

Locations