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Does Cricoid Pressure Reduce the Risk of Aspiration?

NCT02058004 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2016-01-01

No results posted yet for this study

Summary

In modern anesthesia practice, the application of cricoid pressure during intubation is not infrequently used with the goal of preventing gastric-to-pulmonary aspiration. The evidence to support this practice is very scarce, and there have recently been many reports in the literature questioning the safety of cricoid pressure during intubation. Therefore, the goal of this study will be to randomize those at risk for microaspiration to receive cricoid pressure versus no cricoid pressure during intubation. We will specifically exclude those patients thought to be at the highest risk of aspiration (it is considered standard of care to perform cricoid pressure during intubation of this population). We will include those patients with some risk factors for aspiration (it is not considered standard of care to apply cricoid pressure during intubation of this population).

Conditions

  • Microaspiration
  • Acute Respiratory Distress Syndrome (ARDS)
  • Hospital Acquired Pneumonia

Interventions

PROCEDURE

Cricoid pressure

Firm pressure on the cricoid cartilage with the goal of occluding the esophagus during endotracheal intubation.

Sponsors & Collaborators

  • Alfred I. duPont Hospital for Children

    collaborator OTHER

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • John Bohman, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02058004 on ClinicalTrials.gov