Recruiting

Observational Study

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT03990337

Conditions

Endotracheal Intubation

General Anesthesia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Ultrasound

Study Details

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

Study ID

NCT03990337

Start date

Jul 30, 2018

Status verified date

Jun, 2019

Completion date

Jul, 2020

Anticipated

Primary completion date

Jul, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

Interventions

Ultrasound

Ultrasonography of cricoid cartilage.

Primary outcome measure

  • Cricoid pressure effectiveness [ Time Frame: 5 minutes ]

Central Contacts and Locations

Central contacts

Kong Eric You-Ten, MD

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

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G1X5

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Jun 18, 2019

Last verified

Jun, 2019

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2019-06-18.