Placement-Assisted Nasogastric Tube System:

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Field of the Invention:

The present invention relates generally to a means for introducing material into or removing material from the body for therapeutic purposes by a tubular conduit structure inserted through the nostril and into the alimentary tract. More specifically this invention uses a device to assist in determining the placement of an enteral nasogastric tube by using pH or auscultatory feedback.

Description of the Prior Art:

The use of a nasogastric tube, a plastic tube inserted through the nose into the throat and down the esophagus into the stomach, is an important and standard therapeutic and diagnostic technique. The nasogastric tube is commonly used as a conduit for introducing materials such as nutrition or medicines into the stomach or small intestine. It is also used to decompress the stomach to prevent vomiting after major surgery and for removing material from the body. One example is accidentally ingesting a poison or due to an overdose of drugs. It is widely recognized that enteral nutrition provided by a nasogastric tube, or a feeding tube as it is sometimes referred to, is preferred to parenteral nutrition, having many advantages and less complications. Although nasogastric intubation is a widely used, standard technique, it continues to be challenging for clinicians to assure proper placement of the nasogastric tube. Great care and attention must be used to assure the tube is correctly placed. Common inadvertent placement locations include the tracheobronchial tree or pleural space, but even the rare placement in the brain has been reported. Aspiration, the most serious consequence of inadvertent misplacement, occurs when food or medicine is introduced by a tube incorrectly placed into the lungs, trachea, or esophagus, leading to dangerous aspiration pneumonia with its associated
http://bmj.bmjjournals.com/cgi/content/full/326/7386/414 increased incidence of morbidity and mortality. 

Determining correct placement is vital. Complications from improper tube positioning often results in extended hospital stays, or in some instances, result in death. The importance of the intubation procedure and the difficulty of assuring correct placement have led to the development of numerous evaluation and confirmation techniques used either individually or in combination to assess nasogastric tube placement. Radiographic confirmation of the location of the distal end of the tube is the most reliable confirmation technique. Generally, experienced technicians blindly place the nasogastric tube, and then the placement is verified by radiographic confirmation. A standard tube has a radio-opaque marker or strip at the distal end, so the position can be verified by X-ray studies of the chest/abdomen, or if the X-ray cannot confirm the position, the doctor may order fluoroscopy. Radiographic assistance can also be used while placing the tube. While this radiographic confirmation method does assure that a nasogastric tube is in the correct position, it has several negatives. A patient is exposed to significant radiation, especially if the placement is difficult. Further the cost for X-rays is considerable. Additionally, many of the patients requiring nasogastric tubes have multiple pieces of life support equipment. 

Therefore, a substantial amount of time, effort, and hospital staff are required to move, position, and manage these patients while performing the radiographic confirmation. It would be advantageous to provide a method that would incur a significantly lower cost than the traditional radiographic confirmation, decrease hospital staff time, and/or reduce the patientís exposure to radiation. It would also be advantageous to provide a method that would be capable of continuous verification, both during intubation, at the end of the intubation procedure, and in the hours or days following the initial intubation, without increasing radiation exposure. A traditionally used bedside technique to evaluate the placement of a nasogastric tube placement is auscultation of air insufflated through the tube. In this method a trained technician using a stethoscope above the stomach, rapidly fills the tube with a bolus of air, and determines whether the sound generated by the air injected into the tube is from the gastrointestinal system, from the respiratory system, or other location. This is a very economical test method, but the amount of training and clinical experience required is substantial, as may be the time involved trying to determine the location as the trained clinician attempts to correctly differentiate the sounds. 

Another placement evaluation method involves aspiration of fluid from the tube, with pH testing of the aspirate. By using pH paper the acidity of the fluid can be determined. An acidic pH of approximately lower than 5 indicates the correct placement into the stomach, while an aspirate of pH 6 or greater indicates a tube inadvertently positioned in the respiratory system. One problem associated with this method of using the aspirate of the tube is the tendency for small-bore tubes to collapse when suction is applied. Aspirating fluid also requires a significant investment of time and effort by the trained clinician. Also, it is difficult to obtain an aspirate from the tube in dehydrated patients or in certain areas of the stomach where there may be no pool of fluid of sufficient volume to aspirate. It would be advantageous to have a device that decreased the amount of time spent by hospital personnel to aspirate fluid and to test the pH of the fluid every time a pH value was desired. 

Even after a successful initial placement of a nasogastric feeding tube is confirmed, the patient faces an ongoing risk, because over time the distal end of the tube can become mal-positioned, moving from its original location. For example, this may occur due to patient movement or the patient may dislodge the tube because it is uncomfortable. Commonly hospital policies recommend frequent and ongoing placement confirmation, for example before every feeding or at least every six hours. Obviously a great deal of radiation exposure would be received if this confirmation were done by radiology. It would be advantageous to have a device for continual monitoring of the location without the expense and the radiation exposure of repeated X-rays. Accordingly, there is an established need for a timesaving, economical, placement-assisted nasogastric tube that is capable of assisting clinicians during the placement of the nasogastric tube into the proper location and is capable of confirming the location after the initial placement and during utilization, while reducing radiation exposure.

Summary of the Invention:

The present invention is directed to an economical, time-saving placement-assisted nasogastric tube that is capable of assisting clinicians not only in proper tube placement during intubation, but also during the entire time a tube is used, by continuously providing information about the location of the distal end of the tube. A nasogastric tube includes a flexible tube, a feedback initiator attached to the distal end of the flexible tube, a feedback receiver attached to the proximal end of the flexible tube, and a conducting means incorporated into, or connected to, the flexible tube. The conducting means electrically connects the feedback initiator to the feedback receiver. The feedback initiator may be an acoustic transceiver that includes a sound generator and sound receiver or may be a pH sensor. 

The feedback receiver obtains data from the feedback initiator via the conducting means and preferably includes an output device, such as a digital readout or speaker. The data that is output supplies information about the location of the tubeís distal end to the clinician, thereby assisting the clinician in placement of the nasogastric tube. An object of the present invention is to provide a placement-assisted nasogastric tube system that minimizes the patientís exposure to radiation. A further object of the present invention is to provide a placement-assisted nasogastric tube system that provides a significantly lower cost than the cost of the traditional radiographic confirmation. Another object of the present invention is to provide a placement-assisted nasogastric tube system that is configured to continuously monitor the location of the distal end of the tube. An additional object of the present invention is to provide a placement-assisted nasogastric tube system that increases staff efficiency. For further information please contact us.

 

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Inventor:  Terra Projects, Inc.
E-mail:  [email protected]
Phone:  (772) 621-8187
Cell:  (678) 794-5657