Clinical trial NCT02604043: 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
Overall status: TERMINATED
Phase: NA
Conditions: Aspiration, Respiratory
Keywords: supraglottic pH
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2015-11-13
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Number of times pH drops below 5.5.
timeFrame: 24 hours period after placement of pH probe
Secondary outcomes:
measure: The mean of the angle (degrees) of the patient from the lateral position during low pH periods
timeFrame: 24 hours period after placement of pH probe
Other outcomes:
measure: Number of minutes the pH is less than 5.5 in a 24 hour
timeFrame: 24 hours period after placement of pH probe
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Brett Alvis, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.