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

NCT02604043 | Terminated

• 1 other identifier: 131893
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aspiration, Respiratory

Keywords

supraglottic pH

Outcome Measures

Primary Outcomes (1)

• Number of times pH drops below 5.5.

  24 hours period after placement of pH probe

Secondary Outcomes (1)

• 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

Other Outcomes (1)

• Number of minutes the pH is less than 5.5 in a 24 hour

  24 hours period after placement of pH probe

Study Arms (1)

supraglottic impendence/pH probe

EXPERIMENTAL

Other: pH monitoring; Other: accelerometer monitoring

Interventions

pH monitoring OTHER

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.

supraglottic impendence/pH probe

accelerometer monitoring OTHER

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

supraglottic impendence/pH probe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (2)

• 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.

  PMID: 11473886 BACKGROUND

• 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.

  PMID: 16364934 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Brett Alvis, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Anesthesiology Critical Care Medicine

Study Record Dates

• First Submitted: November 11, 2015
• First Posted: November 13, 2015
• Study Start: August 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: April 4, 2019

Record last verified: 2019-04

Locations

US (1)