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

Aspiration, Respiratory Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02604043
• Other study ID #: 131893
• Status: Terminated
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Aspiration, Respiratory
• Respiratory Aspiration

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