Continuous Supraglottic pH Monitoring in Prolonged Intubated Intensive Care Patients and High Risk Aspiration Intraoperative Patients

Study Overview
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Brief Summary
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This is a pilot prospective cohort study of the incidence of supraglottic pH readings.

Detailed Description
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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.

Official Title
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Continuous Supraglottic pH Monitoring in Prolonged Intubated Intensive Care Patients and High Risk Aspiration Intraoperative Patients

Conditions
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Aspiration, Respiratory

Intervention / Treatment
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* Other: pH monitoring
* Other: accelerometer monitoring


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: supraglottic impendence/pH probe<br> | Other: pH monitoring<br>* 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.<br>Other: accelerometer monitoring<br>* Patient position will be continuously monitored with the accelerometer for the duration of the pH monitoring period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of times pH drops below 5.5. |  | 24 hours period after placement of pH probe | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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supraglottic pH