Recruiting

Observational Study

Sponsor:

RightBio Metrics

Code:

NCT01561729

Conditions

Small Bowel Obstruction

Gastrointestinal Hemorrhage

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RightSpot pH Indicator

Chest radiograph

Study Details

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.

Conditions

Small Bowel Obstruction

Gastrointestinal Hemorrhage

Study ID

NCT01561729

Start date

Jan, 2012

Status verified date

Nov, 2014

Completion date

Dec, 2014

Anticipated

Primary completion date

Dec, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 RightSpot 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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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 RightSpot pH Indicator and chest radiograph.

Interventions

RightSpot pH Indicator

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).

Chest radiograph

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

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Jason Wilson, MD

(813)627-5931tampaerdoc@gmail.com

Locations

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Contacts

Jason Wilson, MD

813-627-5937tampaerdoc@gmail.com

Jennifer Nilsen, RN

(813)844-3162Jenniferanilsen@tgh.org

More Information

Sponsor

RightBio Metrics

Last update posted

Nov 4, 2014

Last verified

Nov, 2014

Keywords

  • nasogastric tube
  • orogastric tube
  • RightSpot pH Indicator
  • suction tube
  • RightBio Metrics
  • RightLevel
  • RightSpot Infant
  • NG Tube
  • pH
  • Gastric Acidity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by RightBio Metrics on 2014-11-04.