Ultrasound-guided Identification of Cricoid Cartilage in Cricoid Pressure

Impact of Ultrasound-guided Identification of Cricoid Cartilage in Cricoid Pressure

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.

Study Overview

• Status: Unknown
• Conditions: Endotracheal Intubation; General Anesthesia
• Intervention / Treatment: Device: Ultrasound

Detailed Description

This is a prospective two-arm randomized controlled single blinded study to be conducted at Mount Sinai Hospital, University of Toronto. The study will be conducted in the operating rooms (OR) with patients as subjects, and OR nurses and scheduled anesthesiologists as participants.Following signed informed consent, patients will be randomized into two groups:(i) Control group (CPG, n=65): cricoid pressure applied by the OR nurse on the cricoid cartilage using finger palpation without ultrasonography and (ii) Ultrasound group (USG, n=65): cricoid pressure applied by the OR nurse on the cricoid cartilage after localization with US. The oesophagus of the patient participants in both groups will also be identified by US. A portable US machine will be present in the operating room for all patients in both groups.

The anesthesiologist scheduled for the surgery is blinded to group allocation and will induce the patient with general anesthesia. The anesthesiologist will provide adequate oxygenation with 100% oxygen to reach an end-tidal oxygen ≥ 90% using mask ventilation. Thereafter, the scheduled anesthesiologist will step out of the operating room. Apneic oxygenation will be maintained using a nasal cannula with 100% oxygen at 5 litres/min. During apneic oxygenation, one of the research anesthesiologists will localize the cricoid cartilage using US (for patients in USG group). Prior to applying cricoid pressure, the nurse will be instructed to use an estimated pressure (of 30 Newtons) that causes discomfort when applied to his/her nasal bridge. The nurse will then apply an estimated 30 Newtons pressure on the cricoid cartilage localized by US for patients in the USG group or blindly without US for patients in CPG group.

The anesthesiologist will then return to the operating room and perform a videolaryngoscopy to directly visualize up to three attempts to pass a lubricated 20F gastric tube at the upper outlet of the esophagus with (i) pressure directly on the cricoid cartilage and (ii) with pressure on the cricoid cartilage shifted to the left and right of the midline. Following removal of the gastric tube and videolaryngoscope, the trachea will be intubated using direct laryngoscopy with a McIntosh blade. Cricoid pressure will be released after the cuff of the endotracheal tube is inflated. Thereafter, the location of the CC (blindly without US) for patients in CPG group will be marked and compared to the location that will be identified with US.

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kong Eric You-Ten, MD; Phone Number: 5270 416-586-4800; Email: eric.you-ten@sinaihealthsystem.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X5
      • Recruiting
      • Mount Sinai Hospital
      • Sub-Investigator: Ashok Kumar Jayaraj, MD
      • Sub-Investigator: Martina Melvin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control group (CPG, n=65); cricoid pressure applied by the OR nurse on the cricoid cartilage using finger palpation without ultrasonography
ACTIVE_COMPARATOR: Ultrasound group (USG, n=65); cricoid pressure applied by the OR nurse on the cricoid cartilage after localization with ultrasonography	Device: Ultrasound; Ultrasonography of cricoid cartilage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cricoid pressure effectiveness	Cricoid pressure effectiveness defined as the failure to pass the gastric tube after 3 attempts	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cormack-Lehane classification	Cormack-Lehane classification for direct laryngoscopy	5 minutes
Cricoid pressure release	necessity of cricoid pressure release for intubation.	5 minutes

Collaborators and Investigators

• Sponsor: Mount Sinai Hospital, Canada
• Investigators: Principal Investigator: Kong Eric You-Ten, MD, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 30, 2018
• Primary Completion (ANTICIPATED): July 1, 2020
• Study Completion (ANTICIPATED): July 1, 2020

Study Registration Dates

• First Submitted: July 30, 2018
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (ACTUAL): June 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 18, 2019
• Last Update Submitted That Met QC Criteria: June 17, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Ultrasound; General Anesthesia; Endotracheal Intubation; Cricoid Cartilage; Cricoid Pressure
• Other Study ID Numbers: 17-0271-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication.
• IPD Sharing Time Frame: Starting 6 months after publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No