A pilot randomized clinical trial assessing the effect of cricoid pressure on risk of aspiration.
BACKGROUND
Patients at risk for microaspiration during elective intubation often receive cricoid pressure in the hopes of mitigating such risk. However, there is scarce evidence to either support or reject this practice. The objective of this investigation was to assess the effect of cricoid pressure on microaspiration and to inform the potential feasibility of conducting a larger, more definitive clinical trial.


METHODS
This was a pilot randomized clinical trial set in the operating rooms of a tertiary referral hospital between August and October of 2014. Patients with risk factors for microaspiration (obesity, gastroesophageal reflux disease, or diabetes) were enrolled. The patients were randomized to either cricoid pressure or no cricoid pressure during induction of anesthesia with endotracheal intubation. Immediately after intubation, a sample of lower airway secretions was collected and analyzed for pepsin A.


RESULTS
A total of 95 patients were evaluated, randomized and completed the study protocol. 46 were randomized to cricoid pressure and 49 to no cricoid pressure. Seven patients crossed-over treatment arms. A total of 18 (19.6%) patients met the pre-defined criteria for microaspiration. In both the intention-to-treat and per-protocol analyses, there were no statistically significant differences in the rate of microaspiration [OR (95% CI)] = 1.39 (0.49-3.92) and 1.30 (0.44-3.86), respectively.


CONCLUSIONS
Utilizing pepsin A as a biomarker of aspiration, this pilot clinical trial did not find evidence for a reduced rate of aspiration or adverse clinical events with the administration of cricoid pressure during elective endotracheal intubation of patients with risk factors for microaspiration.
Department of Anesthesiology, Division of Critical Care Medicine, Mayo Clinic, Rochester, MN, USA.
J Kyle
JK
Bohman
Department of Anesthesiology, Division of Critical Care Medicine, Mayo Clinic, Rochester, MN, USA.
Rahul
R
Kashyap
Department of Medicine, Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Jacksonville, FL, USA.
Augustine
A
Lee
Gastroenterology Research and Clinical Laboratories, Alfred I. duPont Hospital for Children, Wilmington, DE, USA.
Zhaoping
Z
He
Gastroenterology Research and Clinical Laboratories, Alfred I. duPont Hospital for Children, Wilmington, DE, USA.
Sam
S
Soundar
Gastroenterology Research and Clinical Laboratories, Alfred I. duPont Hospital for Children, Wilmington, DE, USA.
Laura L
LL
Bolling
Department of Anesthesiology, Division of Critical Care Medicine, Mayo Clinic, Rochester, MN, USA.
Daryl J
DJ
Kor
D015415:Biomarkers / Q000378:metabolism; D003413:Cricoid Cartilage / Q000503:physiopathology*; D018592:Cross-Over Studies; D017558:Elective Surgical Procedures / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007442:Intubation, Intratracheal / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D010434:Pepsin A / Q000378:metabolism*; D010865:Pilot Projects; D011015:Pneumonia, Aspiration / Q000209:etiology* / Q000378:metabolism; D053717:Pneumonia, Ventilator-Associated / Q000209:etiology* / Q000378:metabolism; D011312:Pressure; D012189:Retrospective Studies; D012307:Risk Factors
D015415:Biomarkers; D010434:Pepsin A
aspiration; cricoid pressure; intubation; microaspiration; pepsin