Continuous Supraglottic pH Monitoring in Prolonged Intubated Intensive Care Patients and High Risk Aspiration Intraoperative Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Vanderbilt University
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Number of times pH drops below 5.5.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
supraglottic impendence/pH probe
Intervention: pH monitoring (Other)
supraglottic impendence/pH probe
Intervention: accelerometer monitoring (Other)
Outcomes
Primary Outcomes
Number of times pH drops below 5.5.
Time Frame: 24 hours period after placement of pH probe
Secondary Outcomes
- 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)
Investigators
Bret Alvis
Assistant Professor Anesthesiology Critical Care Medicine
Vanderbilt University
