Small Bowel ObstructionNCT01561729
Nasogastric/Orogastric Tube Placement Verification Study Using RightSpot pH Indicator to Verify Gastric Acidity
A study testing RightSpot pH Indicator and Chest radiograph in people with Small Bowel Obstruction and Gastrointestinal Hemorrhage, run by RightBio Metrics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Bowel Obstruction, Gastrointestinal Hemorrhage
- What is being tested?
- RightSpot pH Indicator and Chest radiograph
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients less than 18 years of age
- Patient or proxy unwilling or unable to provide informed consent
- Patient with known or suspected pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
Jason Wilson, MD, 813-627-5937, tampaerdoc@gmail.com
Jennifer Nilsen, RN, (813)844-3162, Jenniferanilsen@tgh.org
About this study
Official title: Evaluation of RightBio Metrics', RightSpot pH Indicator, for Rapid Bedside Verification of Proper Nasogastric/ Orogastric Tube Placement in Emergency Department & Intensive Care Unit Patients
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.
Read the detailed description
Primary objective:
To assess the level of accuracy of the RightSpot 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, RightSpot 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 RightSpot 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 RightSpot pH Indicator.
- Being tested
- RightSpot pH Indicator, Chest radiograph
- Keywords
- nasogastric tube, orogastric tube, RightSpot pH Indicator, suction tube, RightBio Metrics, RightLevel, RightSpot Infant, NG Tube, pH, Gastric Acidity
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
Chest radiographRadiation
Also called CXR
Chest radiograph will be taken after tube placement to verify proper positioning of the nasogastric or orogastric tube.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: RightSpot pH Indicator; Radiation: Chest radiograph |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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 RightSpot pH Indicator.
Measured: 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
The time to verification of tube placement will be measured for both chest radiograph and use of RightSpot pH Indicator.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Bowel ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RightBio Metrics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Wilson, MD, Principal investigator, University of South Florida Emergency Medicine Residency Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561729
- Sponsor's protocol ID
- Pro00004691
- Status last verified
- Nov 2014
- First submitted
- 26 Jan 2012
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of RightBio Metrics', RightSpot pH Indicator, for Rapid Bedside Verification of Proper Nasogastric/ Orogastric Tube Placement in Emergency Department & Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT01561729
- Acronym / sponsor ID
- Pro00004691
- Keywords
- nasogastric tube, orogastric tube, RightSpot pH Indicator, suction tube, RightBio Metrics, RightLevel, RightSpot Infant, NG Tube
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- RightBio MetricsIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary objective:
To assess the level of accuracy of the RightSpot 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, RightSpot 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 RightSpot 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 RightSpot pH Indicator.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: RightSpot pH Indicator, Radiation: Chest radiographThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients less than 18 years of age
- Patient or proxy unwilling or unable to provide informed consent
- Patient with known or suspected pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RightSpot pH IndicatorThe 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). | Device | Study group |
| Chest radiographAlso: CXRChest radiograph will be taken after tube placement to verify proper positioning of the nasogastric or orogastric tube. | Radiation | Study group |
Primary outcome
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.
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.
2 secondary outcomes
Confounding factors for using the RightSpot pH Indicator
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Wilson, MD principal investigator
University of South Florida Emergency Medicine Residency Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RightSpot pH Indicator and Chest radiograph in people with Small Bowel Obstruction and Gastrointestinal Hemorrhage, run by RightBio Metrics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jason Wilson, MD ((813)627-5931, tampaerdoc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2014.