Ultrasound-guided Identification of Cricoid Cartilage in Cricoid Pressure

NCT03990337 | Unknown

• 1 other identifier: 17-0271-A
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This study is aimed to provide the evidence that ultrasound-guided identification of the cricoid cartilage can improve effectiveness of cricoid pressure. Ultrasound (US) is well recognized as a technique for identifying the neck landmarks including the cricoid cartilage. Based on the potential results that may show that US could be a tool for improve the effectiveness of cricoid pressure, the investigators expect to disseminate this knowledge to be transformed in the standard technique for helping anesthesiologists and nurses to do pressure in the correct location. It is expected that the greatest impact of this study will lead to improved patient outcomes and safety, particularly in the ones with high-risk for aspiration.

Conditions

Endotracheal Intubation; General Anesthesia

Keywords

Ultrasound; Cricoid Cartilage; Cricoid Pressure; General Anesthesia; Endotracheal Intubation

Outcome Measures

Primary Outcomes (1)

• Cricoid pressure effectiveness

  Cricoid pressure effectiveness defined as the failure to pass the gastric tube after 3 attempts

  5 minutes

Secondary Outcomes (2)

• Cormack-Lehane classification

  5 minutes

• Cricoid pressure release

  5 minutes

Study Arms (2)

Control group (CPG, n=65)

NO INTERVENTION

cricoid pressure applied by the OR nurse on the cricoid cartilage using finger palpation without ultrasonography

Ultrasound group (USG, n=65)

ACTIVE COMPARATOR

cricoid pressure applied by the OR nurse on the cricoid cartilage after localization with ultrasonography

Device: Ultrasound

Interventions

Ultrasound DEVICE

Ultrasonography of cricoid cartilage.

Ultrasound group (USG, n=65)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years,
• ASA physical status I and II,
• body mass index \<28 kg/m2,
• scheduled to undergo surgical procedures requiring general anesthesia and endotracheal intubation.

You may not qualify if:

• cardiac diseases,
• respiratory diseases,
• liver diseases,
• gastroesophageal reflux symptoms,
• anticipated difficult airway and/or anticipated difficult bag-mask ventilation

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

RECRUITING

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Kong Eric You-Ten, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kong Eric You-Ten, MD

CONTACT

416-586-4800; eric.you-ten@sinaihealthsystem.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Single-blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: prospective two-arm randomized controlled single blinded

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: June 18, 2019
• Study Start: July 30, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: June 18, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Starting 6 months after publication

Locations

CA (1)