WO2007134562A1

WO2007134562A1 - Device for endotracheal intubation

Info

Publication number: WO2007134562A1
Application number: PCT/DE2007/000711
Authority: WO
Inventors: Thomas Römer
Original assignee: Universitätsklinikum Schleswig-Holstein
Priority date: 2006-05-18
Filing date: 2007-04-21
Publication date: 2007-11-29
Also published as: DE102006023273B3

Abstract

A system for verifiable positioning of an intubation catheter (10) which serves to insert an endotracheal tube and which is inserted into the trachea of a patient, comprising a device (36) for determining the carbon dioxide content in a gas sample, means (30) for drawing a gas sample from the body of a patient through the inserted intubation catheter (10), and means (30, 28, 34) for feeding the gas sample to the device (36).

Description

Device for endotracheal intubation

The present invention relates to a device for endotracheal intubation in the field of anesthesia and emergency medicine, in particular for blind endotracheal intubation via a laryngeal mask placed in the airway of a patient.

In the field of anesthesia and emergency medicine, the prevention of hypoxia (oxygen deficiency) or the treatment of a "can not ventilate" situation (a situation in which mask ventilation can not be successfully performed) is the top priority in securing the airway A large number of patients require an endotracheal tube in addition to the maintenance of oxygenation by ventilation, while intubation difficulties ("can not intubate" situations) occur at a frequency of 1.5 - 8.5% in the clinic and> 10% in of preclinical emergency medicine. Both in the context of the "can not ventilate" and "can not intubate" situations, the laryngeal mask has a high priority. The American Society of Anesthesiologists recommends the early use of the laryngeal mask in their "practice guides for management of the difficult airway" [(1992), last amended 2002]. Studies show the outstanding therapeutic status of the laryngeal mask for these situations. The standard laryngeal mask, e.g. Essentially described in DE 32 46 673 C2, is therefore stored in almost every operating room and many ambulance service vehicles. After successful securing of the ventilation by laryngeal mask there are various possibilities to perform an endotracheal intubation of the patient.

Thus, in addition to the embodiment as a standard laryngeal mask, the laryngeal mask is also available as an intubation laryngeal mask, as described, for example, in EP 0 571 439 B1, which permits successful blind endotracheal intubation. The success rate after 3 intubation attempts is 87-95% ^{1> 2} . In contrast to the standard laryngeal mask, it allows blind intubation with endotracheal tubes of sizes 6.0 to 8.0 mm. The procedure is suitable for the clinic and the preclinical. However, there are a number of disadvantages for the intubation laryngeal mask. For example, a special tube is required for the intubation laryngeal mask. Due to the minimum usable tube size of 6 mm internal diameter, this can only be used from an age of approx. 6-8 years or> 30 kg body weight. Furthermore, this special tube does not have a "low-pressure" cuff that protects the mucous membranes Both models (reusable and disposable) of the intubation laryngeal mask and the special tubes are expensive and therefore generally not purchased for every operating room stored centrally and are therefore available in an emergency only with a delay. If the standard laryngeal mask has been previously inserted, the intubation lens mask must be changed for blind intubation. Occasionally, the correct insertion of the intubation laryngeal mask for blind intubation can not be achieved in patients with severely impaired head reclination. The reason for this is the rigid shaft of the intubation laryngeal mask in combination with the limited reclination. Similarly, the use of the intubation laryngeal mask may be problematic in patients with a low thyroidal distance. The removal of the intubation laryngeal mask via the in-situ tube is recommended as pressure can be induced by the rigid shaft of the laryngeal mask. This maneuver requires some practice and can be described as awkward.

Although it is also possible to place an endotracheal tube with a maximum inner diameter of 6.0 mm via the standard laryngeal mask by means of a cumbersome procedure using a bronchoscope ² , this approach also has a number of disadvantages. It is a very troublesome and expensive procedure. You need a special bronchoscope and a light source. Due to the inner diameter of the laryngeal mask shaft, it allows a maximum of a tube with an inner diameter of 6.0 mm, which is too small for adult patients. The removal of the laryngeal mask after intubation is associated with a high risk of extubation. To change to a larger tube, a "tube exchanger" is needed, because of the complex procedure and the high costs, this is not a routine procedure, the required material can only be kept to a limited extent and is only available with a delay in an emergency. The method is unsuitable for preclinical emergency medicine.

A more practicable method of intubating the patient via a standard laryngeal mask is to use the COOK "Aintree" Intubation Catheter in conjunction with a special bronchoscope. The "Aintree" Intubation Catheter is pulled across the bronchoscope and passed bronchoscopically through the laryngeal mask Trachea placed. After removal of the bronchoscope and laryngeal mask, the tube is advanced into the trachea via the "Aintree" Intubation Catheter, which serves as a guide bar However, significant disadvantages of this method are the high acquisition costs for the bronchoscope and the risk of damage to the bronchoscope glass fibers due to kinking in the area Transition to the bronchoscope handle, a site of predilection for fiberglass damage when using the Aintree Intubation Catheter. A blind intubation (without Due to the length of the "Aintree" catheter (56 or 83 cm), a bronchoscope with longer than average length (at least 60 cm) is required, otherwise the controllability of the bronchoscope is not given. Also, due to the "Aintree" inner lumen, it must be a very thin bronchoscope with an outside diameter of less than 4.7 mm, which due to the high cost will result in central storage and, in an emergency, the material may be delayed The high price of the special bronchoscope is partly due to the new acquisition.The procedure is also unsuitable for preclinical emergency medicine.

For the "blind" endotracheal intubation via a lying standard laryngeal mask there is currently no practicable method.All of the aforementioned methods require a costly equipment park (intubation laryngeal mask, bronchoscopes with light sources, special bronchoscopes, special tubes, tube exchanger, etc.). ) and possibly additional assistant personnel. They do not use the available resources and, as far as bronchoscopes are not used, are not able to verify the correct endotracheal position of the intubation tube during the intubation process quickly and reliably. Currently, a false intubation is usually recognized only by the resumption of ventilation activity by controlling the composition of the respiratory gases and, if only conditionally meaningful, by the respiratory sounds. A late-onset of false intubation can quickly lead to oxygen deprivation, with this brain-damaging and life-threatening condition occurring much faster in the child than in adults, as children have lower compensatory reserves. By early verification of the correct endotracheal position in the course of the intubation process, time-consuming and tissue traumatizing misintubations could be avoided.

The object of the invention is therefore to develop a device which enables safe and verifϊzierbare, as well as fast, easy and inexpensive endotracheal intubation through the standard laryngeal mask away, without the need for optical aids must be used.

The object is achieved by a device for verifiable positioning of an endotracheal tube by means of an intubation catheter having the features of claim 1. The device according to the invention enables rapid, atraumatic, blind endotracheal intubation via a lying standard laryngeal mask, the correct endotracheal or bronchial position of an intubation catheter serving as a guide for the endotracheal tube being verified by the detection of aspirated CO ₂ on the basis of capnometry. Physiological basis for the detection is the pulmonary gas exchange for CO ₂ due to the CO ₂ _partial pressure difference between blood and alveoli. In addition to bronchoscopy, CO ₂ detection is considered the gold standard for a safe intratracheal position (American Society of Anesthesiologists, 1992, "Practice guidelines for management of the diffcult airway", last amended in 2002).

The American Society of Anesthesiologists recommends the early use of the laryngeal mask in the case of a can not ventilate and / or can not intubate situation, as the intubation laryngeal mask is used in the If a "can not ventilate" situation is delayed, the standard laryngeal mask will be used. This is therefore used more often in emergency situations in comparison to the intubation laryngeal mask more often. The use of the device according to the invention makes possible a blind intubation via the means of the "first choice" and the use of any tube (double-tissue tube, tube with "low-pressure" cuff, "Woodbridge" tube, etc.) Endotracheal intubation with the intubation device according to the invention is simple and the time of a successful intubation is, as experiments on the simulator have shown, at most in the range of the other methods or is tend to be shorter.So with the device according to the invention the blind endotracheal intubation in the context of cardiopulmonary resuscitation without exceeding The maximum time limit for the individual intubation attempt (30 seconds ⁴ ) thus makes it possible to significantly shorten the time until successful endotracheal intubation in the case of unexpectedly difficult intubation, in contrast to intubation via the intubation laryngeal mask with its rigid shaft Intubation device due to the flexible shaft of the standard laryngeal masks in patients with significantly reduced head (eg Rheumatiker) or short thyreomentalen distance to perform successful. In the case of a preserved but significantly reduced mouth opening, the insertion of the laryngeal mask and thus the use of the device according to the invention is possible. Since it does not contain any metal parts, it is also suitable for use in magnetic resonance tomographs. When using a correspondingly smaller dimensioned intubation catheter, the intubation Device can also be used on children. Thus, the use of the device according to the invention is currently the only option for carrying out a blind intubation via a lying standard laryngeal mask in patients under the age of 6-8 years or <30 kg body weight. In the case of blind endotracheal intubation with the device according to the invention, one of the gold standards, the CO ₂ measurement, is used to detect the secure position of the intubation catheter in the aethrough. This early capometric position control avoids time-consuming and tissue-traumatizing misintubations. Furthermore, the device according to the invention can thereby, in contrast to bronchoscopic alternatives, also be used in emergency services, since more and more emergency vehicles have a capnometry unit. The personnel expenditure for a "dif fi cult" airway situation can be reduced, since the device according to the invention makes possible the successful blind intubation without organizing another assistant for material procurement (centrally stored intubation laryngeal mask, bronchoscope, etc.) due to its space-saving and comprehensive storage. Since no elaborate preparations or "several hands" are necessary, the blind intubation with the device according to the invention can also be carried out by one person alone (eg emergency physician with paramedic paramedics). Personnel costs for the disposal and reprocessing of bronchoscopes, the packing of emergency cases for the "difficult airway" after their use, etc. can be reduced .. Since the intubation device according to the invention is lower in acquisition costs than the required material in alternative methods, its Furthermore, the device according to the invention uses available resources: standard laryngeal masks, capnometry and the "normal" endotracheal tubes can be found in almost every anesthesia unit and are not special purchases. Furthermore, the existing expensive material (bronchoscopes, light sources, expensive intubation laryngeal masks with special tubes, etc.) is spared and the duration of the operability increased, since in case of emergency again and again damage to equipment (eg bronchoscopes, light sources, endoscopy towers etc. ) comes. Due to the use of resources and the low costs with resulting widespread distribution, the inventive intubation device significantly reduces the material and repair costs.

The device according to the invention is explained in more detail below with reference to drawings. Show it: 1 is a side view of the intubation catheter according to the invention,

2 shows a cross section through the intubation catheter according to the invention,

3 is a plan view of the intubation catheter according to the invention,

4 is an illustration of the rotary tap and the equipment connected to these,

5 shows a schematic representation of the introduction of the intubation catheter according to the invention through a laryngeal mask into the trachea of a patient,

6 shows a flow diagram illustrating the use of the device according to the invention.

The intubation catheter 10 shown in Fig. 1 is a 600 to 800 mm, preferably 730 mm, long semi-elastic, atraumatic rod having an inner lumen 12 shown in Fig. 2. The outer diameter is 2 to 5 mm, preferably 4 mm, the inner diameter 1 to 4.5 mm, preferably 3 mm. The tip 14 and the lateral sides of the intubation catheter, as shown in FIGS. 1 and 3, have small openings 16 in the distal (front) section, through which a gas sample for positional control can be aspirated. The tip 14 of the intubation catheter 10 is angled at a length of 20 to 50 mm, preferably 40 mm at an angle α of 20 to 50 °, preferably 35 °. The angle α shown in FIG. 1 results from the anatomical conditions. Without the correspondingly angled tip, intubation would take place directly or as a result of the deflection of the intubation catheter 10 in the area of the aryepiglottic plica into the esophagus, as is also clear from FIG. 5. In the case of failure of the "routine intubation catheter" 10 according to the invention in its preferred embodiment (35 ° angle), the insertion test can be undertaken again with an intubation catheter 10 which has an angle of, for example, 45 ° or 25.degree .. The tip 14 of the intubation catheter 10 is also atraumatically constructed by an elastic member 18 preferably located at the base of the tip and a rounded distal end 20 as shown in Figures 1 and 3. Upon tissue contact, it may thus yield, thereby preventing a lesion of the tissue the elastic element 18 of the angled tip 14 whose passage through the Larynxmaskenschaft 40. The Intubati- onskatheter 10 has in a preferred embodiment for orientation during insertion into the laryngeal mask further a marking line 22, which is preferably on the side of the angled tip 14, as is apparent from Fig. 3. In addition, in order to estimate the distance to the exit of the tip from the laryngeal mask shaft and the depth of the intratracheal position, the intubation catheter 10 preferably has a "cm" scale 24 depth mark, as shown in Fig. 1. The proximal (Fig. the end of the intubation catheter 10 carries a plug-in connector 26, see Fig. 1, 3 and 4, for connection to a unit for determining the CO ₂ content, here a capnometry unit 36. When using this device, this serves to verify the intratracheal position of 10. The maximum outer diameter of the plug-in connector 26 corresponds to the outer diameter of the intubation catheter 10. The plug-in connector 26 of the intubation catheter 10 is, as shown in Fig. 4, connected directly or via a hose to a rotary valve 28. Via the rotary valve 28, the Gas sample preferably be sucked with a connected thereto syringe 30. Die Verbindu ng between rotary valve 28 and syringe 30 here is a Luer-lock connection 32. The volume of the syringe is preferably 50 ml. After switching the rotary valve 28 on testing, ie on a connection between the syringe 30 and capnometry 34, the gas sample in the connected capnometry unit 36 is injected. The connection between rotary valve 28 and capnometry supply line 34 is preferably also a luer-lock connection 32. In addition to this manual embodiment, an automatic embodiment is also possible, which performs the suction of the gas sample and its supply to the capnometry unit 36 "at the push of a button of the intubation catheter 10, the capnometry unit 36 displays a CO ₂ value (peak) in the gas sample which is significantly higher than that of the ambient atmosphere (about 0.05% by volume) and close to that in the lung (about 4.0% by volume). If a standard capnography unit 36, as used in operating theaters and rescue vehicles, is connected to the rotary valve 28 via its supply line 34, it may lead to a blockage error in the latter, and this and the associated loss of time To avoid this, an air intake bore 38 or a vacuum valve is attached to the rotary cock connection for the capnometry unit glicht operating the Kapnometrieeinheit 36 after the secondary flow principle during the aspiration of the air sample through the endotracheal tube 10 degrees.

The use of this device provides, as shown in Fig. 6, that for the protection of the respiratory tract first a standard laryngeal mask, consisting of the Layrynxmaskenschaft 40 and the actual laryngeal mask 42, placed in the patient and this is ventilated on this. Should it prove necessary to intubate the patient (eg because there is a risk that blood or stomach contents may enter the airways), the standard laryngeal mask is separated from the respirator, the intubation catheter 10 according to the invention with its distal (front) end through the Laryngeal mask shaft 40 introduced and advanced through this and through the patient-side opening of the laryngeal mask 42 into the trachea 44 of the patient, as shown in Fig. 5. In order to check the correct endotracheal position of the intubation catheter 10, a gas sample from the patient's lungs is aspirated through the distal openings 16 of the intubation catheter via the syringe 30 attached to the proximal end of the intubation catheter 10 at this time, followed by a capnometry unit 36, which is located in most operating theaters and ambulances, partly as a portable version, is present, supplied. The display of a CO ₂ peak when the patient sample is sucked gas sample is considered a sign that the intubation catheter 10 has actually been placed correctly in the trachea 44 of the patient. This early positional control avoids time-consuming and tissue traumatizing misintubations. The location of the intubation catheter 10 may be quickly corrected and rechecked at this location, if necessary, before the standard laryngeal mask is removed from the patient over the intubation catheter 10 at a verified correct location. Alternatively, in the event of an imminent undersupply of the patient with oxygen, after the temporary removal of the intubation catheter via the lying laryngeal mask, it is possible to breathe in between, in order to then carry out a new placement attempt. The actual Endotrachealtubus is advanced after the removal of the laryngeal mask on the remaining in the trachea 44 and thus serving as a guide rod intubation catheter 10 away into the trachea 44 of the patient and fixed there by inflating the Tubuscuffs. Thereafter, the intubation catheter 10 is withdrawn from the endotracheal tube and the latter is connected to the ventilation system. LITERATURE

¹ Langenstein H, Möller F (1998) First experience with the intubation laryngeal mask., Anesthetist 47, 311-319.

² Kundra P, Sujata N, Ravishankar M (2005) Conventional tracheal tubes for intubating through the intubating laryngeal mask airway., Anesth Anaig 100 (1), 284-288.

³ Tonner PH; Scholz J; Pothmann W (1995) The Unexpected Difficult Intubation: Fiberoptic endotracheal intubation via the laryngeal mask. Anasthesiol Intensive Med emergency medicine Schmerzther 30 (3), 192-195.

⁴ Nolan JP, Deakin CD, Soar J, et al. (2005) European Resuscitation Council Guidelines for Resuscitation 2005., Resuscitation (2005) 67Sl ₅ S39- S86.

Claims

1. Arrangement for verifiable positioning of an intubation catheter (10) inserted into the trachea of a patient for insertion of an endotracheal tube,

marked by

a device (36) for determining the carbon dioxide content in a gas sample,

Means (30) for aspirating a gas sample from the body of a patient through the inserted intubation catheter (10) and

Means (30, 28, 34) for supplying the gas sample to the device (36).

2. Arrangement according to claim 1, characterized in that the intubation catheter

(10) represents a 600 to 800 mm long semi-elastic tube with a patient-facing distal and a patient facing away from the proximal proximal end, wherein the outer diameter of 2 to 5 mm and the inner diameter is 1 to 4.5 mm.

3. Arrangement according to one of the preceding claims, characterized in that the intubation catheter (10) in the distal region laterally and / or at its tip (14) has at least one opening (16).

4. Arrangement according to one of the preceding claims, characterized in that the distal end of the intubation catheter (10) is angled at an angle of 20 ° to 50.

5. Arrangement according to one of the preceding claims, characterized in that the distal end of the intubation catheter (10) by an elastic element and a rounded tip (14) is designed atraumatic.

6. Arrangement according to one of the preceding claims, characterized in that the intubation catheter (10) has a connector (26) at the proximal end.

7. Arrangement according to one of the preceding claims, characterized in that the intubation catheter (10) has a marking line on the side of the distal bend at least in the proximal region.

8. Arrangement according to one of the preceding claims, characterized in that the intubation catheter (10) has a length scale.

9. Arrangement according to one of the preceding claims, characterized in that at the proximal end of the intubation catheter (10), a rotary valve (28) is connected.

10. Arrangement according to one of the preceding claims, characterized in that on the rotary valve (28), a syringe (30) and a supply line (34) to the device

(36) is connected.

11. Arrangement according to one of the preceding claims, characterized in that the rotary valve (28) at the connection for the device (36) has a lateral bore (38) or a vacuum valve.

12. Arrangement according to one of the preceding claims, characterized in that it is the device (36) is a Kapnometrieemheit.