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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-07-01

Brief Summary

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

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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.

Conditions

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Aspiration, Respiratory

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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supraglottic impendence/pH probe

Group Type EXPERIMENTAL

pH monitoring

Intervention Type OTHER

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 monitoring

Intervention Type OTHER

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

Interventions

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pH 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.

Intervention Type OTHER

accelerometer monitoring

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

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No