Ultrasound Assessment On Effectiveness of Cricoid Pressure In Paediatric Population
NCT ID: NCT05509335
Last Updated: 2022-08-22
Study Results
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Basic Information
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UNKNOWN
90 participants
OBSERVATIONAL
2022-08-19
2023-12-01
Brief Summary
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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.
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Detailed Description
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The anatomically central oesophagus lies behind cricoid cartilage, by applying CP oesophageal lumen will be occluded. However, it remains debatable if eccentric oesophageal is compressible. Studies were conducted on the adult population. Efficacy of CP has been studied in adult patients by means of magnetic resonance imaging. It was shown that CP was ineffective in occluding the oesophageal lumen in adult patients with an eccentric oesophagus. In addition, the study raised the concern of CP application in itself might result in lateral displacement of the oesophagus. This is further supported by Lim et al.'s study which shows the ineffectiveness of CP in occluding eccentric oesophagus in adult patients.
Contrary to the aforementioned studies, Rice et al's demonstrated oesophagus was occludable regardless of the position. The author hypothesized that the hypopharynx and cricoid move as one anatomical unit and the oesophagus would be compressed following the application of CP.
Although the effectiveness of CP was extensively studied in the adult population, studies on the paediatric population remained scarce. 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 our pilot study, the investigators found out that 90 per cent of the oesophagus in the paediatric population was successfully occluded following the application of CP regardless of its position.
Cricoid pressure is not without risk. CP was associated with oesophageal rupture. It has been known to disrupt the laryngoscopic view of the glottis and cause difficult intubation. Hence, it would be imperative to investigate whether CP is truly effective in occluding the oesophagus and preventing gastric aspiration in the paediatric population.
This would be a prospective observational study to study the real-time dynamic effect of oesophageal position and the effect of anaesthesia on oesophageal position. Most importantly, the investigators are hoping to investigate the effectiveness of CP in occluding oesophagus in the paediatric population.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Age 1-8 years old
* Scheduled for surgery under general anaesthesia requiring tracheal intubation
Exclusion Criteria
* 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
1 Year
8 Years
ALL
Yes
Sponsors
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University of Malaya
OTHER
Responsible Party
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Dr. Cheong Chao Chia
Clinical Anaesthesiologist, Lecturer
Principal Investigators
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Chew Yin Wang, FRCA
Role: STUDY_CHAIR
University of Malaya
Locations
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University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
Countries
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Central Contacts
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Facility Contacts
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References
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Dotson K, Kiger J, Carpenter C, Lewis M, Hill J, Raney L, Losek JD. Alignment of cricoid cartilage and esophagus and its potential influence on the effectiveness of Sellick maneuver in children. Pediatr Emerg Care. 2010 Oct;26(10):722-5. doi: 10.1097/PEC.0b013e3181f39b74.
Andruszkiewicz P, Wojtczak J, Wroblewski L, Kaczor M, Sobczyk D, Kowalik I. Ultrasound evaluation of the impact of cricoid pressure versus novel 'paralaryngeal pressure' on anteroposterior oesophageal diameter. Anaesthesia. 2016 Sep;71(9):1024-9. doi: 10.1111/anae.13518.
Birenbaum A, Hajage D, Roche S, Ntouba A, Eurin M, Cuvillon P, Rohn A, Compere V, Benhamou D, Biais M, Menut R, Benachi S, Lenfant F, Riou B; IRIS Investigators Group. Effect of Cricoid Pressure Compared With a Sham Procedure in the Rapid Sequence Induction of Anesthesia: The IRIS Randomized Clinical Trial. JAMA Surg. 2019 Jan 1;154(1):9-17. doi: 10.1001/jamasurg.2018.3577.
Boet S, Duttchen K, Chan J, Chan AW, Morrish W, Ferland A, Hare GM, Hong AP. Cricoid pressure provides incomplete esophageal occlusion associated with lateral deviation: a magnetic resonance imaging study. J Emerg Med. 2012 May;42(5):606-11. doi: 10.1016/j.jemermed.2011.05.014. Epub 2011 Jun 12.
Other Identifiers
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2021329-9999
Identifier Type: -
Identifier Source: org_study_id
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