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Does Cricoid Pressure Reduce the Risk of Aspiration?

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ClinicalTrials.gov Identifier: NCT02058004
Recruitment Status : Completed
First Posted : February 7, 2014
Last Update Posted : January 1, 2016
Sponsor:
Collaborator:
Alfred I. duPont Hospital for Children
Information provided by (Responsible Party):
John (J Kyle) K. Bohman, M.D., Mayo Clinic

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).

Condition or disease Intervention/treatment Phase
Microaspiration Acute Respiratory Distress Syndrome (ARDS) Hospital Acquired Pneumonia Procedure: Cricoid pressure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Does Cricoid Pressure Reduce the Risk of Aspiration?
Study Start Date : August 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014


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.



Primary Outcome Measures :
  1. Rate of microaspiration [ Time Frame: Within 15 minutes of intubation ]
    Tracheal secretions will be collected and later analyzed for the presence of pepsin A.


Secondary Outcome Measures :
  1. Rate of ARDS [ Time Frame: Within 7 days of intubation ]

Other Outcome Measures:
  1. Rate of hospital acquired pneumonia [ Time Frame: Within 7 days of intubation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02058004


Locations
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United States, Minnesota
Mayo Clinic - Saint Mary's Campus
Rochester, Minnesota, United States, 55905
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Alfred I. duPont Hospital for Children
Investigators
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Principal Investigator: John Bohman, MD Mayo Clinic
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Responsible Party: John (J Kyle) K. Bohman, M.D., Instructor of Anesthesiology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02058004    
Other Study ID Numbers: 13-003837
First Posted: February 7, 2014    Key Record Dates
Last Update Posted: January 1, 2016
Last Verified: December 2015
Keywords provided by John (J Kyle) K. Bohman, M.D., Mayo Clinic:
Microaspiration
ARDS
Hospital acquired pneumonia
Cricoid pressure
Additional relevant MeSH terms:
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Healthcare-Associated Pneumonia
Pneumonia
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Cross Infection
Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes