The Cricoid Pressure in Pediatric Patients
Primary Purpose
Aspiration Pneumonia, Cricoid Cartilage, Pediatric
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
cricoid pressure
Sponsored by
About this trial
This is an interventional prevention trial for Aspiration Pneumonia
Eligibility Criteria
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
Sites / Locations
- Procare Riaya Hospital
- Procare Riaya Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Pediatric cricoid force
Arm Description
one arm 135 pediatric patients
Outcomes
Primary Outcome Measures
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 "
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05290844
Brief Title
The Cricoid Pressure in Pediatric Patients
Official Title
The Cricoid Force Necessary to Occlude the Esophageal Entrance in Pediatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 5, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Procare Riaya Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspiration Pneumonia, Cricoid Cartilage, Pediatric
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
135 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pediatric cricoid force
Arm Type
Other
Arm Description
one arm 135 pediatric patients
Intervention Type
Other
Intervention Name(s)
cricoid pressure
Intervention Description
cricoid force in pediatric patients
Primary Outcome Measure Information:
Title
The Cricoid Force Necessary to occlude the Esophageal Entrance In Pediatric patients
Description
Measuring the cricoid force using Biased Coin Method ( ED90%) in pediatric patients from 3 years up to 14 years using digital device " the Cricometer "
Time Frame
day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamal Abdulkhaleq, MD
Organizational Affiliation
PRH
Official's Role
Study Director
Facility Information:
Facility Name
Procare Riaya Hospital
City
Khobar
State/Province
Eastern
ZIP/Postal Code
31952
Country
Saudi Arabia
Facility Name
Procare Riaya Hospital
City
Khobar
State/Province
Estern
ZIP/Postal Code
31952
Country
Saudi Arabia
12. IPD Sharing Statement
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The Cricoid Pressure in Pediatric Patients
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