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

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Vanderbilt University

Status

Terminated

Conditions

Aspiration, Respiratory

Treatments

Other: accelerometer monitoring
Other: pH monitoring

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

This is a pilot prospective cohort study of the incidence of supraglottic pH readings.

Full 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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

3 participants in 1 patient group

supraglottic impendence/pH probe
Experimental group
Treatment:
Other: accelerometer monitoring
Other: pH monitoring

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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