Aspiration PneumoniaNCT05290844
The Cricoid Pressure in Pediatric Patients
A study testing cricoid pressure in people with Aspiration Pneumonia and Cricoid Cartilage, run by Procare Riaya Hospital at 2 sites in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Aspiration Pneumonia, Cricoid Cartilage, Pediatric
- What is being tested?
- cricoid pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- 5 Apr 2022to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age : 3-14 years ASA 1,2 Easy Identification cricoid cartilage No contre indication of CP
Who cannot join
- ASA 3, 4
- Difficult intubation
- Obese patients
- Contre indication of CP
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites
Procare Riaya Hospital
Khobar, Eastern Province, 31952
Procare Riaya Hospital
Khobar, Estern, 31952
About this study
Official title: 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).
Read the 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.
- Conditions
- Aspiration Pneumonia, Cricoid Cartilage, Pediatric
- Being tested
- cricoid pressure
- Medical subject headings
- Pneumonia, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cricoid pressureOther
cricoid force in pediatric patients
| Study group | Role | What they receive |
|---|---|---|
| Pediatric cricoid force | Other | one arm ( 3 groups)120 pediatric patients Receives: Other: cricoid pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 "
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start5 Apr 2022
- Primary completion30 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aspiration PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procare Riaya Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahed ZEIDAN, Procare Riaya Hospital
- Investigators
- Kamal Abdulkhaleq, MD, Study director, PRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290844
- Sponsor's protocol ID
- PRH09
- Status last verified
- Mar 2024
- First submitted
- 9 Feb 2022
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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. 2026 Jul;45(4):101674. doi: 10.1016/j.accpm.2025.101674. Epub 2025 Nov 7.
PubMed 41207374
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cricoid Force Necessary to Occlude the Esophageal Entrance in Pediatric Patients
- ClinicalTrials.gov ID
- NCT05290844
- Acronym / sponsor ID
- PRH09
- Conditions
- Aspiration Pneumonia, Cricoid Cartilage, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Procare Riaya HospitalUniversity, hospital or other
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric cricoid force | Other | Other: cricoid pressureone arm ( 3 groups)120 pediatric patients |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Age : 3-14 years ASA 1,2 Easy Identification cricoid cartilage No contre indication of CP
Key exclusion criteria (4 listed)
- ASA 3, 4
- Difficult intubation
- Obese patients
- Contre indication of CP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cricoid pressurecricoid force in pediatric patients | Other | Pediatric cricoid force |
Primary outcome
The Cricoid Force Necessary to occlude the Esophageal Entrance In Pediatric patients
Time frame: 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 "
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Derived from this study: PubMed 41207374Zeidan 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. 2026 Jul;45(4):101674. doi: 10.1016/j.accpm.2025.101674. Epub 2025 Nov 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamal Abdulkhaleq, MD study director
PRH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cricoid pressure in people with Aspiration Pneumonia and Cricoid Cartilage, run by Procare Riaya Hospital at 2 sites in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Cricoid Force Necessary to occlude the Esophageal Entrance In Pediatric patients (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05290844, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.