Abstract:
A novel connection device, and method for its use, for connecting a volume displacement detection device and a gas composition detection device in line with an intubation tube is disclosed. The connection device allows a user to combine two systems commonly employed by medical personnel to assess the location of an intubation tube placed into a patient. The two systems have alternate means of assessing the location of an intubation tube in a patient and therefore, when combined into a single unit via the connection device, improve the accuracy of placing a tube in a desired location while reducing or eliminating complications associated with misplacement. A kit comprising components that may be assembled to provide a device for assessing the proper placement of an intubation tube in a patient is also disclosed. The kit may be used in any environment, but is particularly well suited for emergency, pre-hospital settings requiring intubation where quick assembly of the components is essential.

Description:
FIELD OF THE INVENTION 
   The present invention is directed to a device used to connect two or more intubation placement detectors in line with an endotracheal tube (ETT) to provide rapid, alternative methods of assessing whether an ETT has been properly placed in the trachea of a patient. 
   BACKGROUND OF THE INVENTION 
   Ventilation of the lungs is essential to life. Patients in need of medical attention often require assistance with breathing as a result of injury, trauma, or airway obstruction. In an apneic patient, the lungs must be artificially ventilated to ensure proper oxygenation and exchange of gasses within the body. Endotracheal intubation is the technique of placing an endotracheal tube (ETT) into the trachea of a patient, for the purposes of establishing an airway. It is estimated that over 18 million intubations are preformed each year in the US, the majority in the operating room. Because of the close proximity of the esophagous to the trachea, an intubationist may accidentally place the ETT into an esophagous. If the error is detected immediately, no harm results. However, if the incorrect placement is not recognized and the ETT repositioned, within a few minutes irreversible brain damage and/or death may result, due to the lack of oxygen. In an ideal setting, an intubationist places an ETT in one hand and visualizes the glottic opening of the airway by introducing a larygoscope into the mouth. The ETT is then carefully passed into the trachea and attached to a source of oxygen. However, even under such controlled conditions inadvertant esophageal intubations have been reported. (White, S. J. and C. M. Slovis,  Acad Emerg Med  1997:4:89–91) This problem is magnified in out-of-hospital intubations performed, or in the hospital outside of the OR and ER wards and intensive care units under less than ideal conditions such as, for example, at the scene of an accident, or within an ambulance in route to a hospital. Under such stressful and often chaotic conditions, misplacement of an ETT in a patient is not uncommon. 
   In an effort eliminate the danger inherent in unrecognized esophageal intubation, numerous clinical methods and devices have been developed to rapidly assess tube placement. Qualitative methods include direct visualization, observation of chest movement with bag inflation, auscultation of breathing sounds, absence of epigastric sound with ventilation, presence of exhaled tidal volume, reservoir bag compliance, endotracheal cuff maneuvers, absence of air escape, tube condensation with exhalation, absence of gastric contents within the tube and others (O&#39;Connor, R. E. R. A. Swor  Prehospital Emergency Care  July–Sept. 1999). Each of these methods have utility in a limited range of clinical conditions. 
   Quantitative methods have also been employed to better assess endotracheal tube placement. The most common quantitative means to document correct placement of an endotracheal tube (ETT) is to sense carbon dioxide during the exhalation phase of ventilation. The success of this method is based on the difference between the CO 2  concentration in exhaled air (5%) and the CO 2  concentration in esophagael gas (0.2%–0.3%). Documentation of carbon dioxide in the exhaled breath has become the accepted standard for verifying the correct placement of an endotracheal tube, unless the location can be directly visualized, for instance, with a fiberoptic bronchoscope. Numerous devices have been developed for assessing proper endotracheal tube placement through detection of CO 2 , the utility of each varying with the particular clinical condition. 
   The most common CO 2  detection device employed in hospitals is the capnometer. This device is used to monitor the concentration of exhaled carbon dioxide in order to assess the physiologic status of a patient. The device comprises an infrared sensor that continuously monitors and displays CO 2  concentration and generates a waveform (capnogram) that is correlated with a patient&#39;s respiratory cycle to quantitatively assess the adequacy of ventilation. 
   However, these devices are less reliable when there is a pulmonary embolis or a patient is in cardiac arrest. (Garnett, A R et al.,  JAMA  1987; 257: 512–515) Further, traditional capnometers are expensive, sophisticated, and fragile instruments requiring careful calibration and a source of power, making their use in out-of hospital procedures impractical. Thus, in emergency-type settings, a capnometer may be inadequate. In those situations, alternative devices are employed. The most reliable method for verifying proper tube placement in out-of hospital applications is through use of an end-tidal carbon dioxide detection device (Ornato, J P  Ann. Emerg Med  1992; 21:518–523) The EasyCap End-Tidal CO 2  Detector (Nellcor-Mallincrodt-Tyco) is an inexpensive, disposable device that quickly attaches to an ETT to sense exhaled CO 2 . With each breath, CO 2  exhaled passes over an indicator in the device that has been treated with a chemical that turns color in response to high CO 2  concentration. Thus, a change in color of the indicator is indicative of proper placement of the ETT in the trachea because of the substantially higher concentration of CO 2  in exhaled air as previously discussed. Tube placement anywhere but the trachea will not yield a color change. However, even if the ETT is properly placed, the EasyCap, like the more expensive capnometer, is inadequate in those instances where a patient lacks a pulse or has very poor pulmonary perfusion because without CO 2  exchange from pulmonary arterial blood to alveoli, insufficient CO2 will be exhaled to produce a color change. 
   To overcome these problems, other devices that do not directly depend on the detection of CO 2  have been developed. These esophageal detector devices (EDD), work on principles of gas volume displacement and depend on the structural difference between the trachea and the esophagus. In one embodiment, a catheter-tip syringe is connected to an ETT via a length of rubber tubing (Wee, M Y K  Anaesthesia  1988 43:27–29) In use, negative pressure is created within the ETT through aspiration of the syringe chamber, i.e. withdrawal of the plunger from the syringe. If the ETT is placed in the esophagus, the walls of the esophagus collapse upon the ETT in response to this negative pressure, which in turn restricts air-flow that can be easily detected as resistance to plunger movement. However, when the ETT is placed in the trachea this negative pressure is incapable of causing the more rigid trachea to collapse, thereby allowing free exchange of air. Thus, free movement of the plunger is indicative of proper placement within the trachea. (O&#39;Leary J. J.  Anaesthesia and Intensive Care  1988; 16: 299–301) In an alternate embodiment, a rubber bulb is attached to an ETT. (Nunn, J F.  Anaesthesia  1988;43:804) In use, the bulb is compressed prior to attachment to the ETT to create a negative pressure within the ETT. As described above, if the tube is placed within the esophagus air passage becomes restricted as the esophageal walls collapse around the ETT, but air freely flows if the ETT is properly placed in the trachea. Thus, passive re-inflation of the bulb is indicative of tracheal intubation, while the failure of the bulb to re-inflate is indicative of esophageal intubation. Each of these devices is portable, inexpensive, easily assembled and provides faster assessment of ETT position than both the capnometer and EasyCap described above, making them particularly well suited for intubations. performed outside the operating room (e.g. in the recovery room, emergency room, intensive care unit and out in the field). Further, these devices are useful in patients experiencing cardiac arrest because the test results do not depend upon the presence of CO 2  in exhaled gas (Haridas, R P  Update in Anaesthesia  1997;7:6(1)) However, regurgitation of gastric air, distension of the esophagus with air, or an EDD that is not airtight may cause the bulb to re-inflate, giving a false impression of tracheal intubation when the tube is in fact in the esophagus. (Haridas, R P  Update in Anaesthesia  1997; 7:6(3)) Further, although these devices are highly accurate when used in a hospital setting, studies indicate that they are only 50% accurate when used in the field by paramedics (Pelicio, M.  Acad Emerg. Med  1997:4563–568) 
   The National Association of EMS Physicians has recognized that no single technique for assessing ETT tube placement currently used is completely reliable in all circumstances. (O&#39;Connor, R. E. and R. A. Swor  Pre-Hospital Emergency Care ; July-Sept. 1999) Based on the inherent limitations in each device, it has become apparent to the authors that the optimal method of detecting proper ETT placement, particularly in out-of-hospital settings would incorporate both concepts of CO 2  detection and gas volume displacement to increase the accuracy of ETT placement to near 100%. 
   SUMMARY OF THE INVENTION 
   The present invention comprises a connection device useful in connecting a CO 2  detection device and a volume displacement device in line with an endotracheal tube (ETT). The device further comprises at least one positive pressure response valve and at least one negative pressure response valve to allow a user to control the movement of gas. By combining two or more existing ETT placement detectors in one unit, the present device allows a user to rapidly obtain alternate quantitative measurements of ETT placement in a patient in wide variety of clinical settings, both in and out of a hospital. The primary benefit of the present device is the ability to quickly discern with almost complete certainty the location of an ETT. Since incorrect placement of an ETT is not uncommon in situations of low blood flow, particularly cardiac arrest, this device offers several advantages over existing device, including improved specificity, sensitivity and full operation without the need for an electrical hookup. The benefit to the patient in any environment is obvious. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
       FIG. 1  Depicts one embodiment of a device used to connect multiple endotracheal tube placement detection devices in line with and endotracheal tube. 
       FIG. 2A  Depicts one embodiment of the device with a bulb-in-a-bulb volume displacement device, a CO2 detection device and an endotracheal tube connected together as a system. As shown the volume displacement device has been employed to create a negative pressure in the system to retrieve a sample of gas. 
       FIG. 2B  Depicts one embodiment of the device with a bulb-in-a-bulb volume displacement device, a CO2 detection device and an endotracheal tube connected together as a system. As shown the volume displacement device has been employed to create a positive pressure in the system to force the gas collected into a CO 2  detector for analysis. 
       FIG. 3A  Depicts one embodiment of the device with a dual syringe volume displacement device, a CO2 detection device and an endotracheal tube connected together as a system. As shown the volume displacement device has been employed to create a negative pressure in the system to retrieve a sample of gas. 
       FIG. 3B  Depicts one embodiment of the device with a dual syringe volume displacement device, a CO2 detection device and an endotracheal tube connected together as a system. As shown, the volume displacement device has been employed to create a positive pressure in the system to force the gas collected into a CO 2  detector for analysis. 
   

   DESCRIPTION OF THE PREFERRED EMBODIMENT 
     FIG. 1  shows a novel device, generally represented at  100 , used to connect both a CO 2  detection device and a volume displacement detector in line with an ETT. In a preferred embodiment the device comprises first  101  and second  102  volume displacement detector portals, a CO 2  detector portal  103  and an endotracheal tube portal  104 . The portals  101 ,  102 ,  103  and  104  are configured to connect with other appropriate devices via slip fittings, friction fittings, threaded fittings, or similar detachable fittings. The device comprises first  111  and second  113  positive pressure response valves which open when positive pressure is applied to the device  100  (see  FIGS. 2B and 3B ). First  110  and second  112  negative response valves are also incorporated into the device  100  and configured such that they open when negative pressure is applied to the device  100 . (see  FIGS. 3A and 3B ) Preferably, the device is manufactured from inexpensive material such that it may be disposed of following use. 
     FIG. 2A  shows one embodiment of the device with an EASYCAP™ CO 2  detector, a bulb-in-a bulb volume displacement detector, and an endotracheal tube connected. The device  100  is connected to a volume displacement detector  201 , which preferably comprises an inner balloon  202   a  enclosed within an outer balloon  202   b . The volume displacement detector  201  is connected with the device  100  such that the detectors&#39; inner balloon  202   a  communicates with the first volume displacement detector portal  101 , and the detectors&#39; outer balloon  202   b  communicates with the second volume displacement detector portal  102 . A CO 2  detector  210  is connected to the device  100  via the CO 2  detector portal  103 . As shown the CO 2  detector comprises an intake port  211  leading to a CO 2  indicator  212  which may be visualized by a user, and an exhaust port  213 . An endotracheal tube (ETT)  220  is connected to the device  100  via the endotacheal tube portal  104 . These components are assembled as a system having a system volume and a system pressure. In use, a three step process is commenced to obtain two indications of the proper placement of an ETT tube. First a clinician inserts the endotracheal tube into the mouth or nose and throat of a patient. Second, a negative pressure is created in the system. This is done by compressing the volume displacement detector  201  and then connecting it to the device  100 . As the detector  201  attempts to regain its original shape and by increasing its volume, a partial vacuum (negative pressure) is created in the system. This negative pressure forces both first  110  and second  112  negative pressure response valves to open. As the first valve  110  opens, atmospheric air is drawn into the CO 2  detector  210  via an exhaust port  213 , over an indicator  212 , out of the detector  210  via the intake port  213 , and into the device  100  where it passes through the open first valve  110  and into the inner balloon  202   a  to aid re-inflation. In this instance, the CO 2  detector does not exhibit a color change because there is insufficient CO 2  in atmospheric air to activate the indicator  212 . Simultaneously, the second negative pressure response valve  113  opens. In response to the negative pressure generated, gas moves out a patient, passes through the ETT  220 , through the open second negative pressure response valve  113  and into the outer balloon  202   b . If the tube is misplaced into the esophagus, the negative pressure created within the ETT will cause the flexible walls of the esophagus to collapse around the end of the tube, thereby preventing air from flowing through the valve  113  and into the outer balloon  202   b . If however, the tube is properly placed into the trachea, the rigid, ringed walls of the trachea will not collapse around the tube in response to the negative pressure, and air will freely flow from the patient through the valve and into the outer balloon  202   b  causing it to re-inflate. Rapid, passive inflation of the detector  201  is indicative of tracheal intubation. However, if the tube is mistakenly placed into the esophagus, the detector may passively inflate as a result of gastric distension or other causes as previously described, and provide a false reading. Thus, to ensure accurate assessment of ETT placement, a second measurement is employed. 
     FIG. 2B  depicts the third step of the process which comprises compressing the volume displacement detector  201  thereby decreasing the system volume and increasing the system pressure which forces gas retrieved from second step, out of the detector, through first  111  and second  112  positive pressure response valves, and into a CO 2  detection device  210 . As shown, an EasyCap End Tidal CO 2  detector (Nellcor-Mallincrodt-Tyco) is employed as the CO 2  detector. However, one skilled in the art will recognize that multiple variations on CO 2  detection devices fall within the scope of this disclosure. When a user compresses the volume detector device  201 , gas from the inner balloon  202   a  is forced into the device  100 , causing the system volume to decrease and the system pressure to increase which in turn forces a first positive pressure response valve  111  to open, whereupon the gas escapes to the outside environment. Simultaneously, gas from the outer balloon  202   b  is forced into the device  100 , which in turn forces a second positive pressure response valve  112  to open. This gas proceeds through the valve  112  and into the CO 2  detector  210  via the intake port  211 . The gas then passes over a CO 2  indicator  212  before exiting the detector  210  via an exhaust port  213 . If the ETT is properly placed in the trachea, this gas will have a CO 2  concentration sufficient to trigger a color change in the detector that is indicative of tracheal intubation. If the ETT has not been properly placed, the gas will have a low CO 2  concentration indicating it has come from the stomach or area other than the trachea, and no color change will occur. 
   In another embodiment, dual syringes are substituted for the bulb-in-a-bulb design shown in  FIGS. 2A and 2B . All other elements remain the same.  FIG. 3A  shows the device with a preferred embodiment of a dual syringe  301  design attached. The dual syringe comprises first  302   a  catheter-tip syringe having a plunger  303   a  and a barrel  304   a , and second  302   b  catheter-tip syringe having a plunger  303   b  and a barrel  304   b . The first syringe  302   a  and second syringe  302   b  are connected to first  310   a  and second  310   b  lengths of tubing which are in turn connected to a first  101  and second  102  volume displacement device connectors respectively. Preferably, the dual syringes are connected together such that first  303   a  and second  303   b  plungers operate in tandem, and first  304   a  and second  304   b  barrels can accumulate a volume of gas from different locations, i.e. atmosphere, or patient. When all components are connected together, a system having a system volume and a system pressure is created. 
   Like the system described in  FIGS. 2A and 2B , use of this embodiment requires three steps. First, a clinician inserts an endotracheal tube into the mouth or nose and throat of a patient.  FIG. 3A  depicts the second step of the process. Prior to connecting the first  310   a  and second  310   b  lengths of tubing to the first  101  and second  102  volume detection device connectors, the syringe plungers pushed toward the tips of the dual syringe. A negative pressure is then created in the system by simultaneously withdrawing the plungers from the syringe barrels. A partial vacuum (negative pressure) is created which forces the first  110  and second  112  negative pressure response valves to open. Atmospheric air is drawn through the CO 2  detector, through the first valve  110  and into the first barrel  304   a  in a manner identical to that described for the inner balloon  202   a  (see  FIG. 2A ). Simultaneously, air is drawn through the ETT  220 , through the open second valve  112  and into the second barrel  304   b . If the ETT is accidentally placed in the esophagus, the walls will collapse around the end of the ETT, making withdrawal of the first  303   a  and second  303   b  plungers difficult. Thus, recoil of the plungers following withdrawal is evidence of improper intubation, whereas free movement of the plungers is evidence of proper intubation.  FIG. 3B  depicts step three of the process which comprises creating a positive pressure in the system to force gas collected from step two out of the first  304   a  and second  304   b  barrels of the dual syringe  301  and into a CO 2  detection device  210 . First  303   a  and second  303   b  plungers are pushed toward the tips of the dual syringe thereby decreasing the system volume and increasing the system pressure to force the gas through out of the barrels. Gas is forced out of the first  304   a  barrel, passes through the first  310   a  length of tubing, and into the device  100  which forces open the first positive pressure response valve  111  to allow the gas to escape to the environment. Simultaneously gas is forced out of the second barrel  304   b , through the second  310   b  length of tubing and into the device  100  which forces a second  113  positive pressure response valve to open, allowing gas to move into the detector  210 . Gas enters the detector  210  via the intake port  211 , passes over the indicator and then out of the device  210  via the exhaust port  213 . If the tube is properly situated in the trachea, the gas will contain a concentration of CO 2  sufficient to trigger the indicator. 
   Each detector provides a different mode. i.e. calorimetric, visual, etc., of assessing the placement of an ETT. The device allows for the assemblage of a wide variety of detection devices to cover all environments in which it may be employed. The device, may be used anywhere to assess ETT placement, but is primarily designed for use outside a fully equipped hospital operating room, such as, for example, in an ambulance or other pre-hospital setting. Through combining two efficient ETT placement detection devices, in one system, this invention increases the accuracy of endotracheal tube placement to almost 100%. Use of this device to create an assemblage of detection devices significantly decreases the risk of improper tube placement not uncommon in emergency-type settings, or where a patient has low or no cardiac output. The, device is inexpensive, reliable, simple to use, capable of being incorporated with an ETT quickly and effectively by any user regardless of the level of training, does not require a power supply, and is not subject to calibration errors. Because the present device allows assemblage of a system that can assess ETT placement with practical certainty under any set of conditions, the present device is needed in the field to provide the best, safest level of healthcare possible. 
   One knowledgeable in the art will immediately recognize that the present invention is not limited to using a dual syringe, or bulb-in a bulb volume displacement device. Any device capable of creating a negative pressure which is adaptable for use with the present device falls within the scope of this disclosure. Similarly, the invention is not limited to use of an EasyCap or capnometer CO 2  detection, nor is it limited to CO2 detection devices in general. Any gas detection device that can be adapted for use with the present device that aids in assessing the location of an ETT falls within the scope of this disclosure. Also, other devices utilizing audible, visual, tactile and electrical signals to indicate the position of an ETT may also be employed.