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

Primary Purpose

Aspiration, Respiratory

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

pH monitoring

accelerometer monitoring

About this trial

This is an interventional other trial for Aspiration, Respiratory focused on measuring supraglottic pH

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

supraglottic impendence/pH probe

Arm Description

Outcomes

Primary Outcome Measures

Number of times pH drops below 5.5.

Secondary Outcome Measures

The mean of the angle (degrees) of the patient from the lateral position during low pH periods

Full Information

NCT ID

NCT02604043

First Posted

November 11, 2015

Last Updated

April 2, 2019

Sponsor

Vanderbilt University

1. Study Identification

Unique Protocol Identification Number

NCT02604043

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Terminated

Why Stopped

Lack of support to complete

Study Start Date

August 2016 (undefined)

Primary Completion Date

July 1, 2018 (Actual)

Study Completion Date

July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aspiration, Respiratory

Keywords

supraglottic pH

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

supraglottic impendence/pH probe

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

pH monitoring

Intervention Description

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

Intervention Name(s)

accelerometer monitoring

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of times pH drops below 5.5.

Time Frame

24 hours period after placement of pH probe

Secondary Outcome Measure Information:

Title

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

Other Pre-specified Outcome Measures:

Title

Number of minutes the pH is less than 5.5 in a 24 hour

Time Frame

24 hours period after placement of pH probe

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brett Alvis, MD

Organizational Affiliation

Vanderbilt University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

11473886

Citation

Ng A, Smith G. Gastroesophageal reflux and aspiration of gastric contents in anesthetic practice. Anesth Analg. 2001 Aug;93(2):494-513. doi: 10.1097/00000539-200108000-00050.

Results Reference

background

PubMed Identifier

16364934

Citation

Clayton J, Jack CI, Ryall C, Tran J, Hilal E, Gosney M. Tracheal pH monitoring and aspiration in acute stroke. Age Ageing. 2006 Jan;35(1):47-53. doi: 10.1093/ageing/afj007.

Results Reference

background

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

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