RightBio Metrics: Common Questions Answered

Clinical Evidence

General Questions

The RightBio Metrics products are the only FDA cleared/CLIA waived pH indicators for confirming gastric acidity for tubes ending in the stomach. pH paper and strips are not FDA cleared or CLIA waived. Additionally, RightBio Metrics devices are fully enclosed systems that protect from gastric acid exposure and do not require calibration.

RightSpotpH® SmallBore indicators fit small bore tubes (primarily feeding) that are 10Fr or less in diameter. RightSpotpH® fits large bore tubes (primarily suction) that are >10Fr in diameter. The pH scale ranges from 4.5-7 in .05 increments.

No, our products are designed to work with all manufacture brands and size NG/OG feeding tubes. If you use Vygon Nutrisafe 2 or EnFit compatible tubes, please let us know. We can work with you to get the appropriate adapters.

Currently, you can use an adapter. We have plans in place to make our products ENFit compatible. Having said that, most US hospitals have not adopted ENFit yet, so we are working with multiple companies to ensure our products meet whichever NG/OG tube they use in their hospital.

No, the pH indicators and the syringe used to withdraw aspirate cannot be reused. Once aspirate is obtained, please remove the pH indicator with the syringe attached and dispose of according to your hospitals policy.

An important first step to obtaining aspirate is to push a small amount of air into the NG/OG tube prior to attempting to get aspirate. For infants 0.5-2cc, for pediatric patients 5-10cc and for adults 10cc or more. Please use your clinical judgement.

If you are still not able to obtain aspirate, lay the patient on their left side for 10 minutes, push air into the NG/OG tube again as directed and re-attempt. In most cases if the NG/OG tube is in the stomach, aspirate will be obtained. If not, follow your hospitals protocol for further instruction.

For additional information on obtaining aspirate please note the following studies:

  • NHS Resource Set Initial Placement for Nasogastric and Orogastric Tubes, July 2016
  • The Journal of Neonatology/Perinatology-Neonatal Intensive Care Journal, Fall 2015, p. 64, Dr. Gregory Martin

You do NOT need to calibrate or do quality controls on the RightSpotpH® indicators. Unlike pH paper or strips, our pH indicators are protected from light, air and humidity which are the three environmental factors that make un-protected pH strips/paper inaccurate

Only enough to change the color of the pH indicator. Once you see the color change, stop pulling aspirate. For the RightSpotpH® SmallBore it is ~.02cc and for the RightSpotpH® it is ~0.5cc.

Can these pH indicators be used on patients that have acid reflux and/or hiatal hernias?

In reflux or after vomiting the amount of residual gastric juice in the esophagus or oropharynx is not enough to fill the tube and indicator. Substantial amounts of aspirate that are in the oropharynx should be suctioned away immediately. Smaller amounts of gastric fluid due to acid reflux do not remain in the esophagus as the fluid is pushed into the stomach via peristalsis. For a hiatal hernia to be large enough to have the feeding tube or NG tube curl up is very rare. Reflux and Hiatal Hernias should not affect the RightSpotpH® indicators readings, however always follow your hospital protocol for final determination.

Yes. Published studies in the United States and United Kingdom demonstrate that despite patients being on medications designed to suppress gastric acid, the majority are still well below a pH of 5.

Some hospital check pH prior to each feed/medication delivery. Others check pH at shift change. While others only check at initial placement and suspected misplacement. Please follow your hospitals protocol for final determination. There are multiple published cases of tubes confirmed in the stomach and then later migrating into the lungs. Frequent checks can save lives.

It depends. If the aspirate has digested, coagulated blood that looks like coffee grounds, YES. If the aspirate is bright red, NO.

After a bolus feed, we recommend waiting 60 minutes before taking a pH reading. Always remember to clear the line with air immediately after a feeding and then again prior to taking a pH reading. If you don’t clear the line with air the next time you take a pH reading you will be pulling the feeding solution and/or medication into the pH indicator, not the true gastric content.

Yes, however the recommendation is to stop the continuous feed, clear the line with air and wait 5-60 minutes (depending on your hospitals protocol) then take the pH reading. The waiting period allows the gastric content to acidify.

Tubes can still be mis-placed into the lung and cause extensive damage. There are documented cases of the tube placed around the cuff on the endotracheal tube therefore it is important to confirm proper placement.

Gastrocult is FDA cleared for determining if there is blood in the aspirate; it does not distinguish between 5-7pH, exposes the healthcare work to aspirate and readings need to be completed by lab within two minutes of obtaining aspirate. Gastrocult is NOT FDA cleared to use to assist in placing tubes.

CO2 Now only indicates if the NG/OG tube is in the lungs, it does not confirm gastric placement.

Cortrack uses imaging and requires a highly skilled user to determine NG/OG tube placement. It has not been shown to be effective determining whether these tubes are in the lungs however can be used to determine gastric vs. post-pyloric placement. Cortrack requires a unique NG tube which costs $65-$80/each and a capital equipment purchase of $15,000 for the monitor. Our products can be used by any trained healthcare professional or caretaker and are much less expensive and do not require any capital equipment.

The IRIS system is like endoscopy and requires a highly skilled user. It is not indicated for pediatric patients. Published studies state that it is 60% accurate in determining NG/OG tube placement upon initial insertion and over time degrades to 30% accuracy.

US and U.K. patient safety alerts and studies have called for the immediate discontinuation of auscultation because of the high rates of misplacement associated with it. Publishes studies such as Children’s Hospital of Philadelphia (CHOP) 2015 article state that misplacement ranges 21-56%. There is NO clinical evidence to support auscultation yet there is a large body of evidence recommending and supporting the use of pH.

US Alerts

  • Child health patient safety organization (CHPSO) 2012 Alert
  • Children’s Hospital Association (CHA) 2012
  • American Association of Critical Care Nurses (AACN) 2016 Alert

EU Alerts

  • National Patient Safety Association (NPSA) 2011 Alert
  • National Patient Safety Association (NPSA)2016 Alert

ENA (Emergency Nurses Association) Clinical Practice Guidelines 2015

No. These pH indicators are FDA cleared/CLIA waived for gastric confirmation.

No. They are single-use only. The syringe may not be reused either. After obtaining aspirate sufficient to change the pH indicator color, please remove the pH indicator attached to the syringe and dispose of according to your hospitals policy.

Though you personally may not have experienced a misplaced NG/OG tube, published studies report that 21-56% of tubes are not in the stomach. Statistics indicate that it is only a matter of time.

The Instructions-for-Use state that the indicator should be read within two minutes of the color change.

Yes, our pH products are ideal for the homecare setting where caretakers are not trained or capable of using other methods to confirm gastric NG/OG tube placement and may not provide the appropriate environmental controls for working with pH strips or paper.

The United Kingdom uses pH first line and only confirms NG/OG tube placement with x-ray if results are non-conclusive. There are many US hospitals adopting similar protocols such as CHOP (Children’s Hospital of Philadelphia). Please follow your hospital protocol for final determination.

The cost is reimbursable in the E.D. It also may be reimbursable in-patient, depending on how your hospital bills for Point of Care Tests. If your hospital gets reimbursed for bedside blood glucose they should be able to be reimbursed for our product. The CPT Code is 83986QW and the reimbursement ranges from $4.80 -$7.00, depending on the payer.

NICU

Yes. Published studies in the United States and United Kingdom state that neonates’ stomachs produce acid.

  • The Journal of Neonatology/Perinatology-Neonatal Intensive Care Journal, Fall 2015, p. 64, Dr. Gregory Martin
  • NHS National Patient Safety Association, Reducing the harm caused by misplaced gastric feeding tubes in babies under the care of neonatal units, 2005

Yes. Published studies in the US and U.K. state that it is possible to obtain aspirate from neonates. See studies referenced above.

Yes. The RightSpotpH® SmallBore will accommodate tubes 10Fr or smaller.

Yes. Please ask your local sales representative for a list of NICU’s currently using the RightSpotpH® SmallBore.

Emergency Department

Yes. The RightSpotpH® will fit large bore tubes >10Fr.

Yes, true, however lung tissue is fragile and easily damaged. Putting lung tissue to suction can cause issues such as pneumonitis to an already critically ill patient which leads to poor clinical outcomes and increased length of stay. Do you want tissue placed to suction or feeding for possibly hours? Additionally, if the patient is not scheduled for x-ray do you want to expose them unnecessarily for an NG/OG tube confirmation and wait the additional time to for the x-ray to be read? Our pH indicators will give you an immediate response and this time savings could improve your patient’s overall time spent in the ED.

The ENA Clinical Practice Guidelines 2015 do not recommend auscultation for confirming tube placement. Their recommendation is to use x-ray, followed by pH. If the patient is not scheduled for x-ray do you want to expose them unnecessarily for an NG/OG tube confirmation and wait the additional time to for the x-ray to be read. Our pH indicators will give you an immediate response and this time savings could improve your patient’s overall time spent in the ED.

Yes. Our CPT Code is 83986QW and the reimbursement ranges from $4.80 -$7.00, depending on the payer.

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