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

April 2, 2019 updated by: Bret Alvis, Vanderbilt University
This is a pilot prospective cohort study of the incidence of supraglottic pH readings.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
24 hours period after placement of pH probe

Other Outcome Measures

Outcome Measure
Time Frame
Number of minutes the pH is less than 5.5 in a 24 hour
Time Frame: 24 hours period after placement of pH probe
24 hours period after placement of pH probe

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Investigators

  • Principal Investigator: Brett Alvis, MD, Vanderbilt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

November 11, 2015

First Submitted That Met QC Criteria

November 11, 2015

First Posted (Estimate)

November 13, 2015

Study Record Updates

Last Update Posted (Actual)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 131893

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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