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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

Tracking Information
First Submitted Date  ICMJE January 26, 2014
First Posted Date  ICMJE February 7, 2014
Last Update Posted Date January 1, 2016
Study Start Date  ICMJE August 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
Rate of microaspiration [ Time Frame: Within 15 minutes of intubation ]
Tracheal secretions will be collected and later analyzed for the presence of pepsin A.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
Rate of ARDS [ Time Frame: Within 7 days of intubation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 6, 2014)
Rate of hospital acquired pneumonia [ Time Frame: Within 7 days of intubation ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Does Cricoid Pressure Reduce the Risk of Aspiration?
Official Title  ICMJE Does Cricoid Pressure Reduce the Risk of Aspiration?
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).
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Microaspiration
  • Acute Respiratory Distress Syndrome (ARDS)
  • Hospital Acquired Pneumonia
Intervention  ICMJE Procedure: Cricoid pressure
Firm pressure on the cricoid cartilage with the goal of occluding the esophagus during endotracheal intubation.
Study Arms  ICMJE
  • Experimental: Cricoid pressure
    Patients randomized to receive cricoid pressure during endotracheal intubation.
    Intervention: Procedure: Cricoid pressure
  • No Intervention: No cricoid pressure
    Patients randomized to receive no cricoid pressure during endotracheal intubation.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 27, 2014)
95
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2014)
450
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02058004
Other Study ID Numbers  ICMJE 13-003837
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John (J Kyle) K. Bohman, M.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Alfred I. duPont Hospital for Children
Investigators  ICMJE
Principal Investigator: John Bohman, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP