Aspiration, Respiratory
Conditions
Keywords
supraglottic pH
Brief summary
This is a pilot prospective cohort study of the incidence of supraglottic pH readings.
Detailed description
Aspiration is a serious morbidity that leads to an increase in both patient mortality and duration of hospital stays. Many practices exist within the hospital setting whose goal is to help prevent clinically significant aspiration including preoperative starvation, pharmaceutically reducing gastric acidity, facilitating gastric drainage, postural changes, cricoid pressure, endotracheal cuff pressure modification, and maintenance of a competent lower esophageal sphincter. However, to date, no monitoring system exists to help a clinician identify active aspiration. At present, video fluoroscopy, is the gold standard for detecting aspiration. This pilot prospective cohort study will examine the incidence of supraglottic pH readings. A continuous pH/impedence sensor will be placed immediately above the glottic opening in four high risk populations: burn patients who are intubated, intubated post-stroke patients, patients undergoing robotic prostectomy, and in patients undergoing peritoneal tumor debulking and chemotherapy. The presence of acidic fluid above the glottic opening will be measured using a supraglottic impendence/pH probe attached to an endotracheal tube.
Interventions
OTHERpH monitoring
After endotracheal intubation, the impedence/pH probe will be placed under indirect visualization using a McGrath MAC video laryngoscope directly above the vocal cords. The sensor will remain in place for the duration of the surgery or for 24 hours in ICU patients. At that time, the device will be manually removed by a member of the study staff.
Patient position will be continuously monitored with the accelerometer for the duration of the pH monitoring period.
Sponsors
Vanderbilt University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are scheduled to undergo robotic prostatectomy. * Patients undergoing peritoneal tumor debulking and chemotherapy * Mechanically ventilated Burn Intensive Care Unit (BICU) Patients * Mechanically ventilated Neuro Care Unit (NCU) Patients who have suffered a stroke
Exclusion criteria
* ICU patients who are not receiving enteral feeds * Patients who present for tumor debulking or robotic prostatectomy who receive preoperative H2 blockers, proton pump inhibitors, antacids or metoclopramide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of times pH drops below 5.5. | 24 hours period after placement of pH probe |
Secondary
| Measure | Time frame |
|---|---|
| The mean of the angle (degrees) of the patient from the lateral position during low pH periods | 24 hours period after placement of pH probe |
Other
| Measure | Time frame |
|---|---|
| Number of minutes the pH is less than 5.5 in a 24 hour | 24 hours period after placement of pH probe |
Countries
United States
Outcome results
None listed