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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02604043
Other study ID # 131893
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date August 2016
Est. completion date July 1, 2018

Study information

Verified date April 2019
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date July 1, 2018
Est. primary completion date July 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Ng A, Smith G. Gastroesophageal reflux and aspiration of gastric contents in anesthetic practice. Anesth Analg. 2001 Aug;93(2):494-513. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Number of minutes the pH is less than 5.5 in a 24 hour 24 hours period after placement of pH probe
Primary Number of times pH drops below 5.5. 24 hours period after placement of pH probe
Secondary 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
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