Does Cricoid Pressure Reduce the Risk of Aspiration?
| Status: | Completed |
|---|---|
| Conditions: | Pneumonia, Hospital, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2014 |
| End Date: | October 2014 |
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).
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).
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.
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.
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
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