Nasogastric/ Orogastric Tube Placement Verification Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of South Florida
Sponsor:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01561729
First received: January 26, 2012
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

This study will evaluate the use of a novel device used to determine if there is proper placement of a nasogastric or orogastric tube.


Condition Intervention
Small Bowel Obstruction
Gastrointestinal Hemorrhage
Device: EZ-NG Device
Radiation: Chest radiograph

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of a Novel Device, EZ-NG pH Indicator, for Rapid Bedside Verification of Proper Nasogastric/ Orogastric Tube Placement in Emergency Department & Intensive Care Unit Patients

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Determination of proper placement of ng/og tube [ Time Frame: Participants will be followed until the determination of proper placement of the ng/og tube is made. This is anticipated to be less than 3 hours. ] [ Designated as safety issue: Yes ]
    The pH will be assessed by visual inspection of pH paper within the device. If the pH is noted to be less than 4.5 then the placement will be considered to be within the stomach.


Secondary Outcome Measures:
  • Confounding factors for using the EZ-NG device [ Time Frame: Participants will be followed until the determination of proper placement of the ng/og tube is made. This is anticipated to be less than 3 hours. ] [ Designated as safety issue: Yes ]
    A subgroup analysis will be done to determine whether gross blood in the stomach, presence of acid-reducing medications, or trauma affects the accuracy of NG/OG placement determination by the EZ-NG pH Indicator.

  • Time to confirmation of tube placement [ Time Frame: Participants will be followed until the determination of proper placement of the ng/og tube is made. This is anticipated to be less than 3 hours. ] [ Designated as safety issue: No ]
    The time to verification of tube placement will be measured for both chest radiograph and use of EZ-NG device.


Estimated Enrollment: 30
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study group
This is the only arm of the study. All patients enrolled will have a nasogastric or orogastric tube placed. All will be assessed by both the EZ-NG device and chest radiograph.
Device: EZ-NG Device
The EZ-NG pH Indicator device is used to confirm proper placement of all types of gastric tubes used for gastric rest, suction, or medicating/feeding by measuring the pH of stomach aspirate. This device is intended for 1 (one) SINGLE USE. The probability of proper placement is higher when the pH is less than or equal to 4.5 and if aspirate has a typical gastric fluid appearance (grassy green, brown, colorless- with possible shreds of off-white mucus or sediment).
Other Name: EZ-NG
Radiation: Chest radiograph
Chest radiograph will be taken after tube placement to verify proper positioning of the nasogastric or orogastric tube.
Other Name: CXR

Detailed Description:

Primary objective:

To assess the level of accuracy of the EZ-NG pH Indicator in determining correct placement of NG/OG tubes as compared to the gold standard of CXR in Emergency Department & ICU patients.

Hypothesis 1: In greater than 90% of the cases, EZ-NG pH Indicator will be successful in confirming the placement of NG/OG tubes by demonstrating a pH of 4.5 or less in patients with CXR proven tube placement.

Hypothesis 2: The time to confirmation of NG/OG tube placement will be significantly less using the EZ-NG pH Indicator than using CXR. The time will be calculated by the start time consisting of the time that the NG/OG tube was placed until the end time, which will be when the device pH Indicator testing is performed. The time to confirmation using the gold standard of a CXR will begin when the NG/OG tube is placed and end when the CXR is available on PACS (picture archiving and communication system).

Secondary objective:

To determine via subgroup analysis whether gross blood in the stomach, presence of acid-reducing medications, or trauma affects the accuracy of NG/OG placement determination by the EZ-NG pH Indicator.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 18 years and older
  • Patient or proxy willing to provide informed consent
  • Patients who require placement of a nasogastric/orogastric tube, in the ED or ICU, as standard of care, AND a member of the study staff is available and present for NG/OG tube placement.
  • It is anticipated that the patient will remain in the ED/ICU in order to obtain EZ-NG pH Indicator reading and verifying CXR

Exclusion Criteria:

  • Patients less than 18 years of age
  • Patient or proxy unwilling or unable to provide informed consent
  • Patient with known or suspected pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561729

Contacts
Contact: Jason Wilson, MD (813)627-5931 tampaerdoc@gmail.com

Locations
United States, Florida
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Jason Wilson, MD    813-627-5937    tampaerdoc@gmail.com   
Contact: Jennifer Nilsen, RN    (813)844-3162    Jenniferanilsen@tgh.org   
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Jason Wilson, MD University of South Florida Emergency Medicine Residency Program
  More Information

No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01561729     History of Changes
Other Study ID Numbers: Pro00004691
Study First Received: January 26, 2012
Last Updated: July 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
nasogastric tube
orogastric tube

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Intestinal Obstruction
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes
Intestinal Diseases

ClinicalTrials.gov processed this record on August 28, 2014