Ultrasonography, InterventionalNCT04317976
Ultrasound Guided Cricoid and Paralaryngeal Pressure
A study testing paralaryngeal pressure and cricoid pressure in people with Ultrasonography, Interventional, run by University of Malaya at 1 site in Malaysia.
Trial summary
The primary objective is to study impact of upper airway ultrasonography in guiding anaesthetic assistant into providing accurate cricoid pressure, or both cricoid and paralaryngeal pressure in those with oesophagus deviation, achieving sonographic proven oesophageal occlusion compared to those without ultrasound… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ultrasonography, Interventional
- What is being tested?
- paralaryngeal pressure and cricoid pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Feb 2019to 31 Jul 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective list Under general anaesthesia Not intubated prior to OT
Who cannot join
- Below 18 years old Pregnant Neck deformities Previous maxillofacial surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Ultrasound Guidance on the Performance of Accurate Cricoid and Paralaryngeal Pressure
The primary objective is to study impact of upper airway ultrasonography in guiding anaesthetic assistant into providing accurate cricoid pressure, or both cricoid and paralaryngeal pressure in those with oesophagus deviation, achieving sonographic proven oesophageal occlusion compared to those without ultrasound guidance.
Read the detailed description
All patients consented for the study were having their airway examined via US. Cross sectional sonography of the airway was performed to determine the anatomic relationship of the oesophagus relative to the trachea:
- before induction of anaesthesia
- after GA before external airway pressure manoeuvre
- after GA with external airway pressure manoeuvre.
US guided CP was applied on subjects with central oesophagus; CP and PLP were applied on subject with eccentric oesophagus anatomy.
PLP was performed by lateral compression on the eccentric oesophagus by fingertips under US guidance. To standardised the application of CP and PLP, only 2 well trained investigators were allowed to performed the CP and PLP, US scan on airway and patient recruitment. The conduct of trial involved 2 investigators where first investigator provide US scan, and second investigator provide compression of CP or PLP using fingertips guided by the instruction of first investigator.
- Conditions
- Ultrasonography, Interventional
- Being tested
- paralaryngeal pressure, cricoid pressure
- Keywords
- Anatomy, oesophagus, ultrasound, incidence, cricoid, paralaryngeal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paralaryngeal pressureOther
cricoid pressure with paralaryngeal pressure by fingertips applied under ultrasound guidance
cricoid pressureOther
cricoid pressure by fingertips applied under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| Centrally located oesophagus post GA | Active comparator | Oesophagus remained central after general anaesthesia, cricoid pressure applied by fingertips under ultrasound guidance Receives: Other: cricoid pressure |
| Eccentric located oesophagus post GA | Experimental | Oesophagus eccentric located after general anaesthesia, paralaryngeal pressure and cricoid pressure applied by fingertips under ultrasound guidance Receives: Other: paralaryngeal pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with eccentric oesophagus under general anesthesia, successfully occluded by using cricoid and paralaryngeal pressure.
we are studying the effectiveness of cricoid pressure versus cricoid and paralaryngeal pressure(novel technique) in those patients with eccentric oesophagus under general anaesthesia. We use ultrasound to determined the position of the oesophagus after patient under general anaethesia ( to group them under central oesophagus and eccentric oesophagus) and also to determine the success of oesophagus occlusion.
Measured: ultrasound assessment of oesophagus done after general anaesthesia, during application of cricoid pressure, and during application of cricoid and paralaryngeal pressure
Secondary outcomes (1)
The number of patients with central oesophagus under general anesthesia, successfully occluded by using cricoid pressure.
The objective is to study the effectiveness of cricoid pressure in those patients with central oesophagus under general anaesthesia. We use ultrasound to determined the position of the oesophagus after patient under general anaethesia, and also to determine the success of oesophagus occlusion.
Measured: ultrasound assessment of oesophagus done after general anaesthesia and during application of cricoid pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start1 Feb 2019
- Primary completion30 May 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Ultrasonography, InterventionalStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The study is a case-control intervention study, where all and every participant will be both the case and the control of their own.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Lim Siu Min, University of Malaya
- Investigators
- Siu Min Lim, M. Anaes, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317976
- Sponsor's protocol ID
- 2018118-6867
- Other IDs
- 45835
- Status last verified
- Mar 2020
- First submitted
- 9 Nov 2019
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee D, Czech AJ, Elriedy M, Nair A, El-Boghdadly K, Ahmad I. A multicentre prospective cohort study of the accuracy of conventional landmark technique for cricoid localisation using ultrasound scanning. Anaesthesia. 2018 Oct;73(10):1229-1234. doi: 10.1111/anae.14399. Epub 2018 Jul 25.
PubMed 30044502Rice MJ, Mancuso AA, Gibbs C, Morey TE, Gravenstein N, Deitte LA. Cricoid pressure results in compression of the postcricoid hypopharynx: the esophageal position is irrelevant. Anesth Analg. 2009 Nov;109(5):1546-52. doi: 10.1213/ane.0b013e3181b05404.
PubMed 19843793Andruszkiewicz 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 27523050Byas-Smith M, Prinsell JR Jr. Ultrasound-guided esophageal occlusion during rapid sequence induction. Can J Anaesth. 2013 Mar;60(3):327-8. doi: 10.1007/s12630-012-9847-9. Epub 2012 Dec 20. No abstract available.
PubMed 23263978Votruba J, Zemanova P, Lambert L, Vesela MM. The Role of Airway and Endobronchial Ultrasound in Perioperative Medicine. Biomed Res Int. 2015;2015:754626. doi: 10.1155/2015/754626. Epub 2015 Dec 14.
PubMed 26788507Bhatia N, Bhagat H, Sen I. Cricoid pressure: Where do we stand? J Anaesthesiol Clin Pharmacol. 2014 Jan;30(1):3-6. doi: 10.4103/0970-9185.125683.
PubMed 24574584Kei J, Utschig EE, van Tonder RJ. Using Ultrasonography to Assess the Effectiveness of Cricoid Pressure on Esophageal Compression. J Emerg Med. 2017 Aug;53(2):236-240. doi: 10.1016/j.jemermed.2017.04.025. Epub 2017 Jun 8.
PubMed 28602458Smith KJ, Dobranowski J, Yip G, Dauphin A, Choi PT. Cricoid pressure displaces the esophagus: an observational study using magnetic resonance imaging. Anesthesiology. 2003 Jul;99(1):60-4. doi: 10.1097/00000542-200307000-00013.
PubMed 12826843Smith KJ, Ladak S, Choi PT, Dobranowski J. The cricoid cartilage and the esophagus are not aligned in close to half of adult patients. Can J Anaesth. 2002 May;49(5):503-7. doi: 10.1007/BF03017931.
PubMed 11983669SELLICK BA. Cricoid pressure to control regurgitation of stomach contents during induction of anaesthesia. Lancet. 1961 Aug 19;2(7199):404-6. doi: 10.1016/s0140-6736(61)92485-0. No abstract available.
PubMed 13749923
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ultrasound Guidance on the Performance of Accurate Cricoid and Paralaryngeal Pressure
- ClinicalTrials.gov ID
- NCT04317976
- Acronym / sponsor ID
- 2018118-6867
- Conditions
- Ultrasonography, Interventional
- Keywords
- Anatomy, oesophagus, ultrasound, incidence, cricoid, paralaryngeal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 23 Mar 2020 (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.
The primary objective is to study impact of upper airway ultrasonography in guiding anaesthetic assistant into providing accurate cricoid pressure, or both cricoid and paralaryngeal pressure in those with oesophagus deviation, achieving sonographic proven oesophageal occlusion compared to those without ultrasound guidance.
Detailed description
All patients consented for the study were having their airway examined via US. Cross sectional sonography of the airway was performed to determine the anatomic relationship of the oesophagus relative to the trachea:
- before induction of anaesthesia
- after GA before external airway pressure manoeuvre
- after GA with external airway pressure manoeuvre.
US guided CP was applied on subjects with central oesophagus; CP and PLP were applied on subject with eccentric oesophagus anatomy.
PLP was performed by lateral compression on the eccentric oesophagus by fingertips under US guidance. To standardised the application of CP and PLP, only 2 well trained investigators were allowed to performed the CP and PLP, US scan on airway and patient recruitment. The conduct of trial involved 2 investigators where first investigator provide US scan, and second investigator provide compression of CP or PLP using fingertips guided by the instruction of first investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The study is a case-control intervention study, where all and every participant will be both the case and the control of their own.
| Arm | Type | Receives |
|---|---|---|
| Centrally located oesophagus post GA | Active comparator | Other: cricoid pressureOesophagus remained central after general anaesthesia, cricoid pressure applied by fingertips under ultrasound guidance |
| Eccentric located oesophagus post GA | Experimental | Other: paralaryngeal pressureOesophagus eccentric located after general anaesthesia, paralaryngeal pressure and cricoid pressure applied by fingertips under ultrasound guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective list Under general anaesthesia Not intubated prior to OT
Key exclusion criteria (1 listed)
- Below 18 years old Pregnant Neck deformities Previous maxillofacial surgery
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 |
|---|---|---|
| paralaryngeal pressurecricoid pressure with paralaryngeal pressure by fingertips applied under ultrasound guidance | Other | Eccentric located oesophagus post GA |
| cricoid pressurecricoid pressure by fingertips applied under ultrasound guidance | Other | Centrally located oesophagus post GA |
Primary outcome
The number of patients with eccentric oesophagus under general anesthesia, successfully occluded by using cricoid and paralaryngeal pressure.
Time frame: ultrasound assessment of oesophagus done after general anaesthesia, during application of cricoid pressure, and during application of cricoid and paralaryngeal pressure
we are studying the effectiveness of cricoid pressure versus cricoid and paralaryngeal pressure(novel technique) in those patients with eccentric oesophagus under general anaesthesia. We use ultrasound to determined the position of the oesophagus after patient under general anaethesia ( to group them under central oesophagus and eccentric oesophagus) and also to determine the success of oesophagus occlusion.
1 secondary outcome
The number of patients with central oesophagus under general anesthesia, successfully occluded by using cricoid pressure.
Time frame: ultrasound assessment of oesophagus done after general anaesthesia and during application of cricoid pressure
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 23 Mar 2020.
- Background: PubMed 30044502Lee D, Czech AJ, Elriedy M, Nair A, El-Boghdadly K, Ahmad I. A multicentre prospective cohort study of the accuracy of conventional landmark technique for cricoid localisation using ultrasound scanning. Anaesthesia. 2018 Oct;73(10):1229-1234. doi: 10.1111/anae.14399. Epub 2018 Jul 25.
- Background: PubMed 19843793Rice MJ, Mancuso AA, Gibbs C, Morey TE, Gravenstein N, Deitte LA. Cricoid pressure results in compression of the postcricoid hypopharynx: the esophageal position is irrelevant. Anesth Analg. 2009 Nov;109(5):1546-52. doi: 10.1213/ane.0b013e3181b05404.
- 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 23263978Byas-Smith M, Prinsell JR Jr. Ultrasound-guided esophageal occlusion during rapid sequence induction. Can J Anaesth. 2013 Mar;60(3):327-8. doi: 10.1007/s12630-012-9847-9. Epub 2012 Dec 20. No abstract available.
- Background: PubMed 26788507Votruba J, Zemanova P, Lambert L, Vesela MM. The Role of Airway and Endobronchial Ultrasound in Perioperative Medicine. Biomed Res Int. 2015;2015:754626. doi: 10.1155/2015/754626. Epub 2015 Dec 14.
- Background: PubMed 24574584Bhatia N, Bhagat H, Sen I. Cricoid pressure: Where do we stand? J Anaesthesiol Clin Pharmacol. 2014 Jan;30(1):3-6. doi: 10.4103/0970-9185.125683.
- Background: PubMed 28602458Kei J, Utschig EE, van Tonder RJ. Using Ultrasonography to Assess the Effectiveness of Cricoid Pressure on Esophageal Compression. J Emerg Med. 2017 Aug;53(2):236-240. doi: 10.1016/j.jemermed.2017.04.025. Epub 2017 Jun 8.
- Background: PubMed 12826843Smith KJ, Dobranowski J, Yip G, Dauphin A, Choi PT. Cricoid pressure displaces the esophagus: an observational study using magnetic resonance imaging. Anesthesiology. 2003 Jul;99(1):60-4. doi: 10.1097/00000542-200307000-00013.
- Background: PubMed 11983669Smith KJ, Ladak S, Choi PT, Dobranowski J. The cricoid cartilage and the esophagus are not aligned in close to half of adult patients. Can J Anaesth. 2002 May;49(5):503-7. doi: 10.1007/BF03017931.
- Background: PubMed 13749923SELLICK BA. Cricoid pressure to control regurgitation of stomach contents during induction of anaesthesia. Lancet. 1961 Aug 19;2(7199):404-6. doi: 10.1016/s0140-6736(61)92485-0. No abstract available.
- Individual participant dataSharing planned: No
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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.
Siu Min Lim, M. Anaes principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paralaryngeal pressure and cricoid pressure in people with Ultrasonography, Interventional, 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 1 inclusion and 1 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 23 Mar 2020. 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?
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 number of patients with eccentric oesophagus under general anesthesia, successfully occluded by using cricoid and paralaryngeal pressure. (time frame: ultrasound assessment of oesophagus done after general anaesthesia, during application of cricoid pressure, and during application of cricoid and paralaryngeal pressure). 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 NCT04317976, which also lists 10 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 23 Mar 2020.