Ultrasound Assessment On Effectiveness of Cricoid Pressure In Paediatric Population

NCT05509335 | Unknown DMC

• 1 other identifier: 2021329-9999
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aspiration of Food; Pediatric ALL

Keywords

cricoid pressure; oesophagus position; pediatric

Outcome Measures

Primary Outcomes (1)

• Number of oesophagus compressible following application of CP in paediatric population

  A published study quoted 45% lateral displacement of the oesophagus in younger children, the incidence was derived from a retrospective review of CT neck in children. Eccentric oesophagus has been associated with ineffective CP in adults. The investigators use ultrasound to determine the location of the oesophagus relative to the trachea. If the oesophagus is central, we assume CP is effective. On the other hand, if the oesophagus is eccentric, ultrasound would be used to assess the compressibility of the oesophagus following CP.

  Through study completion, average 1 year

Secondary Outcomes (2)

• Determine incidence of eccentric oesophagus in paediatric population under effect of general anaesthesia

  Through study completion, average 1 year

• Determine incidence of lateral displacement of oesophagus during CP

  Through study completion, average 1 year

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

ASA 1 and 2 children aged 1 to 8 years old undergoing general anaesthesia for elective surgery requires muscle paralysis and tracheal intubation. We rule out cases which need rapid sequence induction, high risk of aspiration and difficult airway.

You may qualify if:

• ASA 1, 2
• Age 1-8 years old
• Scheduled for surgery under general anaesthesia requiring tracheal intubation

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

RECRUITING

Related Publications (4)

• 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.

  PMID: 20881908 BACKGROUND

• 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.

  PMID: 27523050 BACKGROUND

• 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.

  PMID: 30347104 BACKGROUND

• 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.

  PMID: 21669510 BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Chew Yin Wang, FRCA

  University of Malaya

  STUDY CHAIR

Central Study Contacts

Chao Chia Cheong, MMed Anaaes

CONTACT

+60163113597; chaochia@um.edu.my

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Anaesthesiologist, Lecturer

Study Record Dates

• First Submitted: August 14, 2022
• First Posted: August 22, 2022
• Study Start: August 19, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 22, 2022

Record last verified: 2022-08

Locations

MY (1)