Does Cricoid Pressure Reduce the Risk of Aspiration?

NCT02058004 | Completed

• 1 other identifier: 13-003837
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Microaspiration; ARDS; Hospital acquired pneumonia; Cricoid pressure

Outcome Measures

Primary Outcomes (1)

• Rate of microaspiration

  Tracheal secretions will be collected and later analyzed for the presence of pepsin A.

  Within 15 minutes of intubation

Secondary Outcomes (1)

• Rate of ARDS

  Within 7 days of intubation

Other Outcomes (1)

• Rate of hospital acquired pneumonia

  Within 7 days of intubation

Study Arms (2)

Cricoid pressure

EXPERIMENTAL

Patients randomized to receive cricoid pressure during endotracheal intubation.

Procedure: Cricoid pressure

No cricoid pressure

NO INTERVENTION

Patients randomized to receive no cricoid pressure during endotracheal intubation.

Interventions

Cricoid pressure PROCEDURE

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

Cricoid pressure

Eligibility Criteria

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

You may qualify if:

• Obesity (BMI\>30)
• Diabetes mellitus
• Gastroesophageal reflux disease (GERD)
• schedule cardiac, aortic vascular or non-cardiac thoracic procedure

You may not qualify if:

• emergent surgery
• risk factors for macroaspiration (non-fasting status, bowel obstruction, achalasia, hiatal hernia, esophageal stricture, esophageal diverticulum), altered level of consciousness, known pregnancy
• preoperative ARDS
• preoperative pneumonia

Sponsors & Collaborators

• Mayo Clinic: lead
• Alfred I. duPont Hospital for Children: collaborator

Study Sites (2)

Mayo Clinic - Saint Mary's Campus

Rochester, Minnesota, 55905, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Healthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John Bohman, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Anesthesiology

Study Record Dates

• First Submitted: January 26, 2014
• First Posted: February 7, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 1, 2016

Record last verified: 2015-12

Locations

US (2)