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

Not Applicable

Terminated

• Conditions: Aspiration, Respiratory
• Interventions: Other: pH monitoring; Other: accelerometer monitoring

• Registration Number: NCT02604043
• Lead Sponsor: Vanderbilt University

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.

Study Timeline

• Study First Submitted: 2015-11-11
• Study First Submitted QC: 2015-11-11
• Study First Posted: 2015-11-13
• Study Start: 2016-08
• Primary Completion: 2018-07-01
• Study Completion: 2018-07-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
supraglottic impendence/pH probe	pH monitoring	-
supraglottic impendence/pH probe	accelerometer monitoring	-

Primary Outcome Measures

Name	Time	Method
Number of times pH drops below 5.5.	24 hours period after placement of pH probe

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States