The Cricoid Pressure in Pediatric Patients

The Cricoid Force Necessary to Occlude the Esophageal Entrance in Pediatric Patients

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).

Study Overview

• Status: Completed
• Conditions: Aspiration Pneumonia; Cricoid Cartilage; Pediatric
• Intervention / Treatment: Other: cricoid pressure

Detailed Description

120 children ASA I or II undergoing different surgeries scheduled to undergo procedures requiring general anesthesia and endotracheal intubation were enrolled in this protocol group1 (40 pts, age 3-5 ysr) group 2 (40 pts,6-8 yrs) and group 3 ( 40 pts, 9-13 yrs) .Following applying of ASA standard monitoring and placement of peripheral iv cannula maximal preoxygenation was achieved (end-tidal oxygen > 90%), and anesthesia was induced with propofol 2 mg/kg, fentanyl 1-1.5 µg/kg and sevoflurane in oxygen/air mixture. Cisatracurium or rocuronuim was given to maintain muscle relaxation. Gentle mask ventilation was begun following an oropharyngeal airway placement. CP was applied by the same anesthesiologist in all patients with his back toward the video monitor. The cricoid cartilage was first identified and then held between the thumb and middle finger and the pressure was applied by the index finger with a force to facilitate the manual ventilation. After loss of consciousness, the force was increased to the predertmined force. The applied cricoid force in successive patients was determined by the response of the previous patient within the same group, using Biased coins up-and-down method in each group. The adjustment force interval was 1 N. Successful insertion of the GT with the adjusted force, was considered ineffective CP and the force was increased 1 N for next patient. Conversely, an unsuccessful GT insertion with the adjusted cricoid force was considered effective CP, and the force was decreased 1 N for the next patient. Tracheal intubation was performed with the appropriate size endotracheal tube while using the same cricoid force, initially tested, and the surgical procedure was begun.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Eastern
    • Khobar, Eastern, Saudi Arabia, 31952
      • Procare Riaya Hospital
  • Estern
    • Khobar, Estern, Saudi Arabia, 31952
      • Procare Riaya Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 14 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pediatric cricoid force; one arm ( 3 groups)120 pediatric patients	Other: cricoid pressure; cricoid force in pediatric patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Procare Riaya Hospital
• Investigators: Study Director: Kamal Abdulkhaleq, MD, PRH

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2022
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: March 11, 2022
• First Posted (Actual): March 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Pneumonia, Aspiration
• Other Study ID Numbers: PRH09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No