Ultrasound Assessment On Effectiveness of Cricoid Pressure In Paediatric Population (NCT05509335) | Clinical Trial Compass
UnknownNot Applicable
Ultrasound Assessment On Effectiveness of Cricoid Pressure In Paediatric Population
Malaysia90 participantsStarted 2022-08-19
Plain-language summary
Cricoid pressure (CP) confers Grade IIA evidence in preventing gastric insufflation during general anaesthesia. However, a retrospective review of computed tomography scans by Dotson et al. shows that 45% oesophagus is eccentric in the paediatric population aged 1 to 8 years old. In adults, the eccentric oesophagus is associated with reduced CP efficacy in occluding oesophagus. To date, no dynamic real-time study has been done to assess the incidence of the eccentric oesophagus in the paediatric population, the efficacy of CP in occluding eccentric oesophagus, and the effect of anaesthesia on oesophageal position.
Any patients aged 1 to 8 years old are eligible to participate This study will be conducted in the operation theatre of UMMC. The investigators plan to perform an ultrasound of the neck throughout the phases of anaesthetic induction and determine the oesophagus position and its compressibility with CP application.
Who can participate
Age range
1 Year – 8 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ASA 1, 2
* Age 1-8 years old
* Scheduled for surgery under general anaesthesia requiring tracheal intubation
Exclusion Criteria:
* Presence of neck mass/ cervical spine pathology, prior neck surgery
* Pathology of the upper respiratory tract
* Anticipated difficult intubation / difficult mask ventilation
* Risk of pulmonary aspiration of gastric contents (eg. Gastroesophageal reflux disease, hiatus hernia, intestinal obstruction)
* Morbid obesity BMI ≥ 35 kg/m2 (above 85th centile) - overweight patients
* Inadequate fasting ( 6 hours solid food/ formula milk, 4 hours breast milk and 2 hours clear fluid) - definite indication for rapid sequence induction
* Uncontrolled cardiopulmonary disease
* Oesophageal conditions: achalasia, Zenker's diverticulum
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of oesophagus compressible following application of CP in paediatric population
Timeframe: Through study completion, average 1 year