Aspiration of FoodNCT05509335
Ultrasound Assessment On Effectiveness of Cricoid Pressure In Paediatric Population
An observational study of Aspiration of Food and Pediatric ALL, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Aspiration of Food, Pediatric ALL
- How many people
- 90 participants
- Where
- 1 siteMalaysia
- Study dates
- 19 Aug 2022to 1 Dec 2023
- Phase
- Observational
- 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 1 year to 8 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- ASA 1, 2
- Age 1-8 years old
- Scheduled for surgery under general anaesthesia requiring tracheal intubation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 50603
Chao Chia Chia, MMed (Anaes), +(60)163113597, chaochia@um.edu.my
About this study
Official title: Ultrasound Assessment On Real Time Effectiveness Of Cricoid Pressure In Paediatric Population Under General Anaesthesia
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.
Read the detailed description
In a survey presented by Society for Paediatric Anaesthesia in 2004, 68% of paediatric anaesthesiologists apply CP to prevent passive regurgitation of food into the pharynx. 33% of respondents use CP to prevent gastric insufflation during mask ventilation. Among the respondent, only 24% responded CP reliably occludes the oesophageal lumen.
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
- Aspiration of Food, Pediatric ALL
- Keywords
- cricoid pressure, oesophagus position, pediatric
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, average 1 year
Secondary outcomes (2)
Determine incidence of eccentric oesophagus in paediatric population under effect of general anaesthesia
A published study was conducted from a retrospective review of CT cervical spine of children which found 45% eccentric oesophagus in younger children. However, the position was determined in awake patients with no effect of the anaesthetic drug. We like to investigate the effect of general anaesthetic agents (in particular muscle relaxant) on oesophagus position.
Measured: Through study completion, average 1 year
Determine incidence of lateral displacement of oesophagus during CP
From our pilot study on 10 children aged < 8 years old, we observed centrally located oesophagus was displaced following the application of CP. We would like to investigate the incidence of this phenomenon and if there is a shift of oesophageal position, would the application of CP be effective in occluding the oesophagus.
Measured: Through study completion, average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start19 Aug 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Aspiration of FoodStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Cheong Chao Chia, University of Malaya
- Investigators
- Chew Yin Wang, FRCA, Study chair, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509335
- Sponsor's protocol ID
- 2021329-9999
- Status last verified
- Aug 2022
- First submitted
- 14 Aug 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: result and data
Publications
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.
PubMed 20881908Andruszkiewicz 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.
PubMed 27523050Birenbaum 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.
PubMed 30347104Boet 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.
PubMed 21669510
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment On Real Time Effectiveness Of Cricoid Pressure In Paediatric Population Under General Anaesthesia
- ClinicalTrials.gov ID
- NCT05509335
- Acronym / sponsor ID
- 2021329-9999
- Conditions
- Aspiration of Food, Pediatric ALL
- Keywords
- cricoid pressure, oesophagus position, pediatric
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 19 Aug 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 22 Aug 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.
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.
Detailed description
In a survey presented by Society for Paediatric Anaesthesia in 2004, 68% of paediatric anaesthesiologists apply CP to prevent passive regurgitation of food into the pharynx. 33% of respondents use CP to prevent gastric insufflation during mask ventilation. Among the respondent, only 24% responded CP reliably occludes the oesophageal lumen.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- ASA 1, 2
- Age 1-8 years old
- Scheduled for surgery under general anaesthesia requiring tracheal intubation
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of oesophagus compressible following application of CP in paediatric population
Time frame: Through study completion, average 1 year
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.
2 secondary outcomes
Determine incidence of eccentric oesophagus in paediatric population under effect of general anaesthesia
Time frame: Through study completion, average 1 year
Determine incidence of lateral displacement of oesophagus during CP
Time frame: Through study completion, average 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Background: PubMed 20881908Dotson 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.
- Background: PubMed 27523050Andruszkiewicz 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.
- Background: PubMed 30347104Birenbaum 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.
- Background: PubMed 21669510Boet 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.
- Individual participant dataSharing planned: Undecided. result and data
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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.
Chew Yin Wang, FRCA study chair
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aspiration of Food and Pediatric ALL, run by University of Malaya at 1 site in Malaysia.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chao Chia Cheong, MMed Anaaes (+60163113597, chaochia@um.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of oesophagus compressible following application of CP in paediatric population (time frame: Through study completion, average 1 year). 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 NCT05509335, which also lists 4 linked publications.
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 22 Aug 2022.