NCT02416219

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2015

Completed
17 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

Enrollment Period

9 months

First QC Date

April 7, 2015

Last Update Submit

March 2, 2016

Conditions

Aspiration Pneumonia

Keywords

Cricoid cartilage, cricoid pressure, obstetric

Outcome Measures

Primary Outcomes (3)

  • Distance between measured Cricoid cartilage (by Assessors) and Ultrasound

    10 minutes

  • The level of difficulty to locate Cricoid cartilage NRS score

    10 minutes

  • Total time required for assessment

    10 seconds

Study Arms (1)

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

Procedure: Cricoid pressureDevice: Ultrasound

Interventions

Cricoid pressurePROCEDURE

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.

Also known as: Sellick's Maneuver
Cricoid Cartilage localization
UltrasoundDEVICE
Cricoid Cartilage localization

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Term Obstetric patients coming for elective cesarean delivery

You may qualify if:

  • Patient 18 years and older
  • ASA 1-2•Having singleton pregnancy.
  • Gestational age \>37.
  • Elective cesarean section

You may not qualify if:

  • Patient refusal.
  • Renal failure.
  • Severe preeclampsia.
  • Non- scheduled caesarean delivery (urgent).
  • Twin pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Science Centre

London, Ontario, Canada

Location

Related Publications (6)

  • 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.

    PMID: 24557105BACKGROUND

  • Benhamou 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.

    PMID: 19412111BACKGROUND

  • Fenton 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.

    PMID: 19144507BACKGROUND

  • Aslani 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.

    PMID: 22366848BACKGROUND

  • Hung 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.

    PMID: 22523407BACKGROUND

  • Singh 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.

    PMID: 20040778BACKGROUND

MeSH Terms

Conditions

Pneumonia, Aspiration

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

PneumoniaRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Indu Singh, MD, FRCPC

    Western University, Schulish school of Medicine, Department of Anesthesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical fellow

Study Record Dates

First Submitted

April 7, 2015

First Posted

April 14, 2015

Study Start

May 1, 2015

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

March 3, 2016

Record last verified: 2016-03

Locations

CA(1)