Aspiration PneumoniaNCT02416219
Efficacy of Surface Landmark Palpation for Identification of the Cricoid Cartilage in Obstetric Patients
An observational study of Aspiration Pneumonia, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Rapid Sequence Induction (RSI), with cricoid pressure is advocated for all obstetric patients undergoing general anesthesia. Applying cricoid pressure correctly is crucial to prevent aspiration. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aspiration Pneumonia
- What is being tested?
- Cricoid pressure and Ultrasound
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- May 2015to Mar 2016
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Term Obstetric patients coming for elective cesarean delivery
Who may be able to join
- Patient 18 years and older
- ASA 1-2•Having singleton pregnancy.
- Gestational age >37.
- Elective cesarean section
Who cannot join
- Patient refusal.
- Renal failure.
- Severe preeclampsia.
- Non- scheduled caesarean delivery (urgent).
- Twin pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Rapid Sequence Induction (RSI), with cricoid pressure is advocated for all obstetric patients undergoing general anesthesia. Applying cricoid pressure correctly is crucial to prevent aspiration. Using Ultrasound guidance we will be assessing the ability of different disciplines of caregivers to correctly localize the cricoid cartilage in obstetric patients by anatomical landmark palpation.
Read the detailed description
Obstetric patients coming for elective cesarean delivery will be recruited for the study. Informed consent will be obtained from the patient. The participant (anesthesiologist, resident, nurse, or RT) will mark the center of the cricoid cartilage with the patient in the sniffing position, using fluorescent "invisible" ink. Another anesthesiologist who is expert in using ultrasound will find the proximal and distal margins of the cricoid cartilage an will draw a line at the middle of the 2 margins. Evaluation of the participant's assessment will be considered accurate if it falls within 5 mm from the ultrasound's measured line .The assessor will also be asked to score the ease of cricoid cartilage palpation between 1 to 10 using a visual analog scoring (VAS) scale. Total time taken for palpation will also be measured.
- Conditions
- Aspiration Pneumonia
- Being tested
- Cricoid pressure, Ultrasound
- Keywords
- Cricoid cartilage, cricoid pressure, obstetric
- Medical subject headings
- Pneumonia, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cricoid pressureProcedure or surgery
Also called Sellick's Maneuver
participants will ask to mark the place where they will apply cricoid pressure if the patients was undergoing rapid sequence induction. US will be used to confirm how accurate they are in their estimation.
UltrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| Cricoid Cartilage localization | The caregiver will be asked to palpate the cricoid cartilage and draw aline where he will apply cricoid pressure during rapid sequence induction Receives: Procedure: Cricoid pressure; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance between measured Cricoid cartilage (by Assessors) and Ultrasound
Measured: 10 minutes
The level of difficulty to locate Cricoid cartilage NRS score
Measured: 10 minutes
Total time required for assessment
Measured: 10 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Aspiration PneumoniaStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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 (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatemah Qasem, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Indu Singh, MD, FRCPC, Principal investigator, Western University, Schulish school of Medicine, Department of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416219
- Sponsor's protocol ID
- 106074
- Status last verified
- Mar 2016
- First submitted
- 7 Apr 2015
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zeidan AM, Salem MR, Mazoit JX, Abdullah MA, Ghattas T, Crystal GJ. The effectiveness of cricoid pressure for occluding the esophageal entrance in anesthetized and paralyzed patients: an experimental and observational glidescope study. Anesth Analg. 2014 Mar;118(3):580-6. doi: 10.1213/ANE.0000000000000068.
PubMed 24557105Benhamou D, Bouaziz H, Chassard D, Ducloy JC, Fuzier V, Laffon M, Mercier F, Raucoules M, Samii K. Anaesthetic practices for scheduled caesarean delivery: a 2005 French national survey. Eur J Anaesthesiol. 2009 Aug;26(8):694-700. doi: 10.1097/EJA.0b013e328329b071.
PubMed 19412111Fenton PM, Reynolds F. Life-saving or ineffective? An observational study of the use of cricoid pressure and maternal outcome in an African setting. Int J Obstet Anesth. 2009 Apr;18(2):106-10. doi: 10.1016/j.ijoa.2008.07.006. Epub 2009 Jan 13.
PubMed 19144507Aslani A, Ng SC, Hurley M, McCarthy KF, McNicholas M, McCaul CL. Accuracy of identification of the cricothyroid membrane in female subjects using palpation: an observational study. Anesth Analg. 2012 May;114(5):987-92. doi: 10.1213/ANE.0b013e31824970ba. Epub 2012 Feb 24.
PubMed 22366848Hung O, Scott J, Mullen T, Murphy M. Waiting to exhale! Anesth Analg. 2012 May;114(5):927-8. doi: 10.1213/ANE.0b013e31823a84ef. No abstract available.
PubMed 22523407Singh M, Chin KJ, Chan VW, Wong DT, Prasad GA, Yu E. Use of sonography for airway assessment: an observational study. J Ultrasound Med. 2010 Jan;29(1):79-85. doi: 10.7863/jum.2010.29.1.79.
PubMed 20040778
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Surface Landmark Palpation for Identification of the Cricoid Cartilage in Obstetric Patients
- ClinicalTrials.gov ID
- NCT02416219
- Acronym / sponsor ID
- 106074
- Conditions
- Aspiration Pneumonia
- Keywords
- Cricoid cartilage, cricoid pressure, obstetric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 14 Apr 2015 (estimated)
- 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.
Rapid Sequence Induction (RSI), with cricoid pressure is advocated for all obstetric patients undergoing general anesthesia. Applying cricoid pressure correctly is crucial to prevent aspiration. Using Ultrasound guidance we will be assessing the ability of different disciplines of caregivers to correctly localize the cricoid cartilage in obstetric patients by anatomical landmark palpation.
Detailed description
Obstetric patients coming for elective cesarean delivery will be recruited for the study. Informed consent will be obtained from the patient. The participant (anesthesiologist, resident, nurse, or RT) will mark the center of the cricoid cartilage with the patient in the sniffing position, using fluorescent "invisible" ink. Another anesthesiologist who is expert in using ultrasound will find the proximal and distal margins of the cricoid cartilage an will draw a line at the middle of the 2 margins. Evaluation of the participant's assessment will be considered accurate if it falls within 5 mm from the ultrasound's measured line .The assessor will also be asked to score the ease of cricoid cartilage palpation between 1 to 10 using a visual analog scoring (VAS) scale. Total time taken for palpation will also be measured.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cricoid Cartilage localization | – | Procedure: Cricoid pressure, Device: UltrasoundThe caregiver will be asked to palpate the cricoid cartilage and draw aline where he will apply cricoid pressure during rapid sequence induction |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Term Obstetric patients coming for elective cesarean delivery
Key inclusion criteria (4 listed)
- Patient 18 years and older
- ASA 1-2•Having singleton pregnancy.
- Gestational age >37.
- Elective cesarean section
Key exclusion criteria (5 listed)
- Patient refusal.
- Renal failure.
- Severe preeclampsia.
- Non- scheduled caesarean delivery (urgent).
- Twin pregnancy.
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 |
|---|---|---|
| Cricoid pressureAlso: Sellick's Maneuverparticipants will ask to mark the place where they will apply cricoid pressure if the patients was undergoing rapid sequence induction. US will be used to confirm how accurate they are in their estimation. | Procedure or surgery | Cricoid Cartilage localization |
| Ultrasound | Device | Cricoid Cartilage localization |
Primary outcome
Distance between measured Cricoid cartilage (by Assessors) and Ultrasound
Time frame: 10 minutes
The level of difficulty to locate Cricoid cartilage NRS score
Time frame: 10 minutes
Total time required for assessment
Time frame: 10 seconds
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 3 Mar 2016.
- Background: PubMed 24557105Zeidan AM, Salem MR, Mazoit JX, Abdullah MA, Ghattas T, Crystal GJ. The effectiveness of cricoid pressure for occluding the esophageal entrance in anesthetized and paralyzed patients: an experimental and observational glidescope study. Anesth Analg. 2014 Mar;118(3):580-6. doi: 10.1213/ANE.0000000000000068.
- Background: PubMed 19412111Benhamou D, Bouaziz H, Chassard D, Ducloy JC, Fuzier V, Laffon M, Mercier F, Raucoules M, Samii K. Anaesthetic practices for scheduled caesarean delivery: a 2005 French national survey. Eur J Anaesthesiol. 2009 Aug;26(8):694-700. doi: 10.1097/EJA.0b013e328329b071.
- Background: PubMed 19144507Fenton PM, Reynolds F. Life-saving or ineffective? An observational study of the use of cricoid pressure and maternal outcome in an African setting. Int J Obstet Anesth. 2009 Apr;18(2):106-10. doi: 10.1016/j.ijoa.2008.07.006. Epub 2009 Jan 13.
- Background: PubMed 22366848Aslani A, Ng SC, Hurley M, McCarthy KF, McNicholas M, McCaul CL. Accuracy of identification of the cricothyroid membrane in female subjects using palpation: an observational study. Anesth Analg. 2012 May;114(5):987-92. doi: 10.1213/ANE.0b013e31824970ba. Epub 2012 Feb 24.
- Background: PubMed 22523407Hung O, Scott J, Mullen T, Murphy M. Waiting to exhale! Anesth Analg. 2012 May;114(5):927-8. doi: 10.1213/ANE.0b013e31823a84ef. No abstract available.
- Background: PubMed 20040778Singh M, Chin KJ, Chan VW, Wong DT, Prasad GA, Yu E. Use of sonography for airway assessment: an observational study. J Ultrasound Med. 2010 Jan;29(1):79-85. doi: 10.7863/jum.2010.29.1.79.
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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.
Indu Singh, MD, FRCPC principal investigator
Western University, Schulish school of Medicine, Department of Anesthesia
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 Pneumonia, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 4 inclusion and 5 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 3 Mar 2016. 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 Canada. 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?
Distance between measured Cricoid cartilage (by Assessors) and Ultrasound (time frame: 10 minutes). The study lists 3 primary outcomes in all. 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 NCT02416219, which also lists 6 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 3 Mar 2016.