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

Vanderbilt University3 enrolled

Overview

This is a pilot prospective cohort study of the incidence of supraglottic pH readings.

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Aspiration, Respiratory

Interventions

pH monitoringOTHER

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.

accelerometer monitoringOTHER

Patient position will be continuously monitored with the accelerometer for the duration of the pH monitoring period.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

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

Time frame: 24 hours period after placement of pH probe

Data from ClinicalTrials.gov

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