The Cricoid Pressure in Pediatric Patients

Sponsor
Procare Riaya Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05290844
Collaborator
(none)
135
2
1
8.9
67.5
7.6

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: cricoid pressure
N/A

Detailed Description

135 children ASA I or II undergoing different surgeries scheduled to undergo procedures requiring general anesthesia and endotracheal intubation were enrolled in this protocol.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 Design

Study Type:
Interventional
Anticipated Enrollment :
135 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Cricoid Force Necessary to Occlude the Esophageal Entrance in Pediatric Patients
Actual Study Start Date :
Apr 5, 2022
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Pediatric cricoid force

one arm 135 pediatric patients

Other: cricoid pressure
cricoid force in pediatric patients

Outcome Measures

Primary Outcome Measures

  1. The Cricoid Force Necessary to occlude the Esophageal Entrance In Pediatric patients [day 1]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 14 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Procare Riaya Hospital Khobar Eastern Saudi Arabia 31952
2 Procare Riaya Hospital Khobar Estern Saudi Arabia 31952

Sponsors and Collaborators

  • Procare Riaya Hospital

Investigators

  • Study Director: Kamal Abdulkhaleq, MD, PRH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahed ZEIDAN, Clinical Professor, Procare Riaya Hospital
ClinicalTrials.gov Identifier:
NCT05290844
Other Study ID Numbers:
  • PRH09
First Posted:
Mar 22, 2022
Last Update Posted:
Apr 13, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 13, 2022