NCT02604043

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aspiration, Respiratory

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-08-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2015-11-13
• Last updated: 2019-04-04

Locations

1 site across 1 country: United States