Does Cricoid Pressure Reduce the Risk of Aspiration?

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).

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome (ARDS); Hospital Acquired Pneumonia; Microaspiration
• Intervention / Treatment: Procedure: Cricoid pressure

Detailed Description

Gastric-to-pulmonary aspiration during induction of anesthesia remains a significant risk in the modern practice of anesthesia.(1) Macroaspiration (grossly visible aspiration) has been clearly associated with severe pulmonary injury.(1-4) More recently, microaspiration (aspiration without grossly visible gastric material) has also been associated with significant morbidity.(2) Specifically, microaspiration has been associated with acute respiratory distress syndrome (ARDS)(5), ventilator associated pneumonia (VAP)(6) and acute respiratory failure due to bronchoconstriction and ventilation-perfusion mismatching. Pepsin A has been shown to be a very specific biochemical marker for gastric-to-pulmonary aspiration.(7) In our previous studies, we demonstrated the rate of microaspiration in normal elective surgical patients without risk factors for aspiration was 4% as detected by the ELISA assay for pepsin A.(8) This compared with a rate of 12.5% in patients with risk factors for microaspiration including obesity, GERD (gastroesophageal reflux disease) and diabetes. One proposed technique to prevent gastric-to-pulmonary aspiration is cricoid pressure. Recently, there has been growing evidence which calls into question the effectiveness of cricoid pressure. Radiologic studies by Smith et al yield indirect evidence to suggest that cricoid pressure may not reliably occlude the esophagus.(9,10) Currently, cricoid pressure for patients with risk factors for microaspiration (obesity, GERD and diabetes) is used commonly but inconsistently.(11) By using the same sampling and analysis techniques employed in our previous microaspiration studies, the currently proposed study will provide a very sensitive and specific assessment of the effectiveness of cricoid pressure to prevent aspiration during elective induction of anesthesia and intubation. Our proposed study would enroll patients with risk factors for microaspiration who are scheduled to undergo high-risk (for pulmonary complications) elective surgery requiring endotracheal intubation. We will exclude those with risk factors for macroaspiration (including bowel obstruction, non-fasting status and esophageal pathology associated with increased risk for macroaspiration such as achalasia and hiatal hernia), because cricoid pressure remains the standard of care for those at risk for macroaspiration at our institution. Those patients enrolled will be randomized to receive cricoid pressure versus no cricoid pressure. Immediately following elective intubation, a sample of tracheal secretions from each patient will be obtained and the pepsin A concentration determined. The primary outcome will be the rate of microaspiration determined by the presence of pepsin A in the trachea. Secondary outcomes of interest will be rates of postoperative pulmonary complications including acute respiratory distress syndrome (ARDS) and hospital-acquired pneumonia (HAP). The findings of this study will provide the most direct evidence yet regarding the effectiveness of cricoid pressure for the prevention of gastric-to-pulmonary aspiration during induction of anesthesia and endotracheal intubation. Ultimately, the findings of this study will improve patient safety by providing accurate prospective evidence regarding the effectiveness and safety of cricoid pressure in this setting, and will further explore the clinical significance of microaspiration.

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - Saint Mary's Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

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

Exclusion criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cricoid pressure; Patients randomized to receive cricoid pressure during endotracheal intubation.	Procedure: Cricoid pressure; Firm pressure on the cricoid cartilage with the goal of occluding the esophagus during endotracheal intubation.
No Intervention: No cricoid pressure; Patients randomized to receive no cricoid pressure during endotracheal intubation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of microaspiration	Tracheal secretions will be collected and later analyzed for the presence of pepsin A.	Within 15 minutes of intubation

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of ARDS	Within 7 days of intubation

Other Outcome Measures

Outcome Measure	Time Frame
Rate of hospital acquired pneumonia	Within 7 days of intubation

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Alfred I. duPont Hospital for Children
• Investigators: Principal Investigator: John Bohman, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: January 26, 2014
• First Submitted That Met QC Criteria: February 6, 2014
• First Posted (Estimate): February 7, 2014

Study Record Updates

• Last Update Posted (Estimate): January 1, 2016
• Last Update Submitted That Met QC Criteria: December 30, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: ARDS; Hospital acquired pneumonia; Microaspiration; Cricoid pressure
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease Attributes; Infant, Newborn, Diseases; Cross Infection; Iatrogenic Disease; Lung Injury; Infant, Premature, Diseases; Healthcare-Associated Pneumonia; Pneumonia; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 13-003837