NCT01561729

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 4, 2014

Status Verified

November 1, 2014

Enrollment Period

2.9 years

First QC Date

January 26, 2012

Last Update Submit

November 3, 2014

Conditions

Small Bowel ObstructionGastrointestinal Hemorrhage

Keywords

nasogastric tubeorogastric tubeRightSpot pH Indicatorsuction tubeRightBio MetricsRightLevelRightSpot InfantNG TubepHGastric Acidity

Outcome Measures

Primary Outcomes (1)

  • Determination of proper placement of ng/og tube

    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.

    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.

Secondary Outcomes (2)

  • Confounding factors for using the RightSpot pH Indicator

    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.

  • Time to confirmation of tube placement

    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.

Study Arms (1)

Study group

EXPERIMENTAL

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 RightSpot pH Indicator and chest radiograph.

Device: RightSpot pH IndicatorRadiation: Chest radiograph

Interventions

RightSpot pH IndicatorDEVICE

The RightSpot 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).

Study group
Chest radiographRADIATION

Chest radiograph will be taken after tube placement to verify proper positioning of the nasogastric or orogastric tube.

Also known as: CXR
Study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 RightSpot pH Indicator reading and verifying CXR

You may not qualify if:

  • Patients less than 18 years of age
  • Patient or proxy unwilling or unable to provide informed consent
  • Patient with known or suspected pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jason Wilson, MD

    University of South Florida Emergency Medicine Residency Program

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Wilson, MD

CONTACT

(813)627-5931tampaerdoc@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2012

First Posted

March 23, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

November 4, 2014

Record last verified: 2014-11

Locations

US(1)