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The below report of a patient death due to barotrauma was taken from the following article: falzon d, alston rp, coley e, montgomery k.Lung isolation for thoracic surgery: from inception to evidence-based.J cardiothorac vasc anesth.2017 apr;31(2):678-693.The author warns the length of a tube exchanger should be noted and caution should be taken with insertion depth.It was then stated, a cook exchange catheter was inserted at an excessive depth followed by administration of high-flow oxygen, leading to the death of a patient from barotrauma.Reference to this particular case was made and further investigation found additional information located at: sheriffdom of glasgow and strathkelvin.Determination of sheriff linda margaret ruxton in fatal accident inquiry into the death of [g.E.], glasgow, 7 april 2010.Available at (https://www.Scotcourts.Gov.Uk/search-judgments/judgment?id=328e86a6-8980-69d2-b500-ff0000d74aa7).Accessed august 10, 2021.On 07apr2010, a (b)(6) year old male patient died as a result of barotrauma as a result of perforation of the right lung as a complication of anaesthetic administration.The patient was undergoing surgery for fracture of the distal phalanx of the right little finger."during anaesthesia for a surgical procedure to repair a fracture of a finger, an unsecured airway exchange catheter inserted into [the patient's] trachea migrated downwards, puncturing the right lung and exiting through the intercostal muscles before becoming lodged in the chest wall.The subsequent introduction of oxygen through the catheter at high volume allowed air to flow directly into the tissues causing widespread surgical emphysema, barotrauma, hypoxia and cardiac arrest." procedure: the first attempt at intubation failed due to inability to lift the tongue and epiglottis out of the way and was therefore unable to visualize the larynx.A second attempt was also unsuccessful.In accordance with the protocol for difficult airways, [the physician] called for assistance from senior colleagues.A laryngeal mask airway (lma) was chosen.A no.4 lma was inserted and connected to the breathing circuit.Ventilation was thus achieved affording a period of stability.The patient's oxygen saturation was recorded as 97% which was satisfactory.The ventilation achieved via the lma was temporary.Anaesthesia could not continue on this basis.Therefore the physician proceeded with the back-up anaesthetic plan: placing an intubating laryngeal mask airway ("ilma") which has an endotracheal (et) tube attached.During the short time it took to remove the lma, insert the ilma and connect it to the breathing circuit, the patient's oxygen saturation fell to 80% and thus the flow of oxygen to the breathing circuit was increased.An attempt to place a size 8 ett through the ilma failed.A size 7 tube was successfully placed.A decision to remove the mask part of the ilma device while leaving the et tube in place was made in order to investigate bleeding possibly due to trauma.The connection from the ett was removed and was noted to be difficult "as the 50mm end-connector attached to the tube was stiff." the cuff was deflated and the stabilizing rod was inserted but at that stage she encountered a difficulty because the rod was not secure.The interface between the stabilizing rod and the et tube was loose.The use of a cook airway exchange catheter was suggested "in order to gain stability and to have a pathway for the airway should the et tube come out with the mask." the cook double lumen extra firm soft tipped airway exchange catheter was inserted when the ilma was still in place when the loose connection with the stabilizing rod was discovered.It was introduced it into the trachea to a point at where the physician met slight resistance which was judged to be the carina.With the cook catheter in place, there was an attempt to remove the imla but the pilot cuff sheared off and created a leak."the secure airway had been compromised and the patient was at risk of aspirating." the whole set including the dysfunctional ett was removed, and an attempt to place a size 9 ett by railroading along the cook catheter was made.Both encountered resistance at the vocal cords and placement was unsuccessful.The ilma was placed again for a temporary stable airway.It was noted that "no instructions were issued or steps taken to ensure the security of the catheter." the cook catheter remained in place in the trachea.It was decided another size 7 ett would be placed under fibre-optic laryngoscope.Additionally, additional oxygen was delivered via the cook catheter.The flow of oxygen was set to 15 litres of oxygen per minute.The normal rate would be 2 litres up to a maximum of 4 litres for delivery via a cook catheter.It appears that this rate of flow continued for some time although the exact period was not clear.Upon reinsertion of the fibre-optic laryngoscope (the first attempt was aborted due to inability of the physician to position himself relative to the patient due to the nurse's location), "everything was swollen and he was unable to see any recognisable structure or anatomical landmarks.There had been a dramatic change in a matter of minutes." "at the same time as [the physician's] second attempt to insert the fibre-optic scope and very shortly after oxygen had been introduced, the patient began to swell up extremely rapidly.There was a sudden swelling of his right arm, right eyelid and the right side of his face.The rate was described as very, very rapid.In association with that swelling was a redness which was a very bright cherry-red colour.Within seconds this swelling spread equally rapidly to the entire face, neck, both arms, upper chest extending down the trunk to the abdomen." the swelling was interpreted as possible anaphylaxis.The patient was then treated for anaphylaxis per protocol.There was no response to the drugs.The swelling did not reduce, nor was there any improvement in oxygenation."at this point adequate ventilation was not being maintained by hand ventilation via the ilma and [the patient's] saturations were falling.The oxygen saturation had fallen to 40% and the heart rate to 42.Rescue procedures were instituted.Surgical assistance was called for to achieve a surgical airway (tracheostomy).[the physician] attempted to perform a cricoidthyroidotomy by pushing a needle through the cricothyroid membrane and inserting a tube into the airway.This was unsuccessful due to the degree of swelling.At this point there was no effective airway and the patient had no pulse showing that there was no cardiac output.Cardio-pulmonary resuscitation (cpr) was commenced in response to cardiac arrest." external cardiac compressions - which were maintained almost continuously over a fifty minute period were carried out.A loud crack from the region of the patient's lower abdomen which made a consulting physician suspect immediately that barotrauma had occurred that the swelling had been caused by surgical emphysema.Both a bilateral pneumothorax and surgical emphysema were confirmed on chest x-ray and chest drains were inserted.An arterial line was inserted into the patient's left foot.Blood results showed hypoxia and that he was acidotic.Resuscitative measures continued.However, "in view of the lack of response to all resuscitative measures, it was felt that further attempts at resuscitation were not appropriate.Resuscitation was stopped and the patient was pronounced dead." examination of the second x-ray disclosed the presence of the cook catheter outside the right lung.It had penetrated through the intercostal muscles and was lodged in the chest wall.Post-mortem examination and cause of death: autopsy "confirmed that the patient died as a result of barotrauma (increased pressure within the chest) in relation to perforation of the middle lobe of his right lung which had occurred as a complication of anaesthetic administration where something had been pushed from within through the outer wall of the lung.This had created a hole in the chest wall.Examination of the chest and neck revealed the presence of subcutaneous emphysema which was associated with a small perforation in his chest wall in relation to the perforating wound in the middle lobe of his right lung.In addition, there was evidence of a residual right-sided pneumothorax (the right lung was collapsed) while the left lung appeared partially collapsed.There was bilateral apical emphysema (at the top of the chest) and evidence of air in the lining of the chest wall, areas of which had been torn away with associated bleeding.There was evidence of bubbling of fat in the chest wall on both sides where air had tracked down.".
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Investigation ¿ evaluation: the report of patient death from barotrauma after catheter insertion at an excessive death was cited in the article lung isolation for thoracic surgery: from inception to evidence-based which was published in the journal of cardiothoracic and vascular anesthesia (volume 31, 2017).The authors of the article, david falzon, md, frca, mrcp, pg cert med, r.Peter alston, mbchb, md, frca, ffpmrca, fficm, emma coley, mbchb, frca, ramc, katriona montgomery, bsc, mbbs, frca represented the department of anaesthesia, critical care and pain medicine from the royal infirmary of edinburgh, edinburgh, united kingdom.In the article, they review the history of lung isolation, including the control of bronchial secretions and positioning, aspiration of bronchial secretions, bronchoscopy, single-lumen endobronchial intubation, bronchial blockers, and double-lumen endobronchial tubes.The indications for lung isolation are reviewed and variations in tracheobronchial anatomy are discussed.Fiberoptic bronchoscopes (fob) are described as well as their proper use.Additionally, techniques of lung isolation are described, descriptions and comparison of endotracheal tubes and bronchial blockers, and special situations to include variations in anatomy are included in the discussion and review.During the discussion of the section ¿changing to a single-lumen tube at the end of the procedure,¿ the authors cautioned that the anesthesiologist should always note the length of the tube exchanger and the depth to which it is inserted.The author references the literature article ¿clinical assessment and management of massive hemoptysis¿ published in the journal of critical care medicine (pg 642-647, 2000) written by jean-baptiste e.In this event, it was reported that a patient died due to barotrauma after the excessive depth of insertion of a cook airway exchange catheter and the administration of high flow oxygen.The patient was a 44-year-old male who weighed 124 kilograms at the time of the event.He had a complex fracture to the terminal phalanx of the digitus minimus manus of the right hand.The patient had full movement with no restriction extending the neck upwards and backward.He had a suspected hiatus hernia and suffered from esophageal acid reflux.The patient¿s thyro-mental distance (tmd) measured 7 cm.He had a mallampati airway classification of class ii.The mallampati classification identifies patients at risk for difficult intubation.A class two score indicates no anticipated difficulty in intubation and the soft palate, fauces, and uvula can be visualized (wajekar, a.S., chellam, s., & toal, 2015).The complaint device was a cook double lumen extra firm soft tipped airway exchange catheter (rpn: c-cae-14.0-100-dlt-ef-st, lot number unknown).According to legal documents, on (b)(6) 2006 the patient underwent surgical repair of the fracture in the right distal phalanx.The physician (dr.(b)(6)) did not have experience using the complaint device.The cook airway exchange catheter was introduced and advanced into the trachea until it met slight resistance, and the resistance was assumed by dr.(b)(6) to be the carina.The cook airway exchange catheter (cae) remained in place while trying to secure the patient's airway when the intubating laryngeal mask (ilma) became separated from the endotracheal tube.Before insertion of the cae, an issue with a loose stabilizing rod in the ilma had been identified.An attempt was made to remove the imla, but the pilot cuff sheared off at the point where it connected to the endotracheal (et) tube.This compromised the airtight seal and put the patient at risk for aspiration.A decline in patient oxygenation from 99 % to 69% occurred.The imla and et tube were removed, and a size 9 et tube was attempted to be placed over the cook airway exchange catheter.However, the et tube would not advance due to resistance at the vocal cords and lack of patient relaxation as a result of medication efficacy duration.Dr.(b)(6) put the ilma back into place and reconnected the breathing circuit as a temporary airway.The cook airway exchange catheter remained in place and the patient¿s oxygen saturation returned to 92%.A fiber optic laryngoscope was used for anatomical visualization.Before the et tube was loaded over the laryngoscope, the patient required pre-oxygenation.This was completed to assist the patient as ventilation does not during the advancement of the et tube.Dr.(b)(6) ordered additional oxygen to be delivered through the cook airway exchange catheter.The cook airway exchange catheter was connected to a free-standing oxygen cylinder at the highest rate by a surgical staff member.The rate was estimated to be 15 liters of oxygen/minute.The exact length of time that oxygen was delivered at this rate is unknown.Dr.(b)(6) attempted to reinsert the fiber optic laryngoscope and discovered a rapid swelling reaction in the patient.The patient had a sudden swelling of his right arm, right eyelid, and the right side of his face.The swelling continued to the rest of the face, neck, bilateral arms, and upper chest to the abdomen.Crepitus in the neck was present when assessed by dr.(b)(6).Solid brawny edema was noted at the neck, top of the chest, and the top of an arm.An anaphylactic reaction to the previously administered rocuronium was suspected.The anaphylaxis treatment protocol was initiated and there was no response to the treatments.The patient¿s oxygen saturation fell to 40% and his heart rate fell to 42 beats per minute (bpm).A cricothyroidotomy was attempted by dr.(b)(6) but was unsuccessful due to swelling.The patient had no effective airway and no pulse.Cardiopulmonary resuscitation (cpr) was performed.During cpr, it was noted by another healthcare professional from the response team (dr.(b)(6)) noted that the patient was very swollen and subcutaneous tissue was very tense.A large ¿crack¿ was heard by dr.(b)(6) from the patient¿s lower abdomen, which was later identified as the air that was released through the scrotum.Bilateral pneumothoraxes were identified despite an oxygen saturation of 90% and no indication of cyanosis.Dr.(b)(6) inserted an intravenous cannula into the mid-curricular line just above the second intercostal space in the upper chest on both sides and was able to aspirate air.The patient¿s right upper arm and chest tension and rigidity decreased slightly.Anaphylaxis protocol continued as well as cpr.Chest drains were indicated, but the decision was made to complete a chest x-ray before proceeding.The on-call general surgeon was unable to perform a surgical airway due to the patient's swelling.While cpr was being performed the rate of oxygen delivery was identified to be too high at 15 liters and was reduced to 2 liters.The x-ray confirmed bilateral pneumothoraxes and surgical emphysema.Bilateral chest drains and an arterial line were inserted into the patient.Cardiac compressions were discontinued.The patient's cardiac output was measured at 30 bpm.Arterial blood gases were analyzed and results indicated that the patient was hypoxic and acidotic.The oxygen saturation levels in the blood gases did not match the levels indicated on the pulse oximeter being used on the patient.It was determined that ventilation had been ineffective.Cpr resumed.A consulting ear nose and throat (ent) surgeon performed a tracheostomy and saturation readings from the pulse oximeter appeared to improve.However, blood gas results indicated there had been no improvement in arterial oxygen saturation, and the metabolic acidosis reflected ongoing cardiac arrest.A second x-ray was performed and showed some resolution of the pneumothoraxes.However, a large bubble-shaped lesion in the stomach was identified.To prevent possible compromise of venous return due to a suspected distended stomach a nasogastric tube was passed to deflate the stomach.The patient was then identified as being in asystole.Asystole protocol began.A cardiologist was consulted, and an ultrasound was performed to exclude cardiac tamponade.Due to a lack of response to all resuscitative measures, further attempts at resuscitation were ceased and the patient was pronounced dead.Post mortem examination of the second x-ray showed the presence of the cook airway exchange catheter outside the right lung.It had penetrated through the intercostal muscles and was lodged in the chest wall.A post-mortem exam was completed, and the cause of death was determined to be barotrauma as a result of oxygenation of the patient after the perforation of the middle lobe of the right lung with the cook airway exchange catheter.A review of the complaint history, instructions for use (ifu), and quality control were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.Cook could not complete a review of the device history record (dhr) or search for other complaints from the product lot due to lack of lot information from the user facility.A device master record review was performed, including quality control procedures.Cook has concluded that sufficient inspection activities are in place to assure functionality and device integrity prior to shipping.The evidence from the complaint file and quality control documents indicates that the complaint device was manufactured to specification as well as other items in the lot or similar devices in the field or in house.The current ifu provided with the set was reviewed and includes the following: "warnings: attention should be paid to insertion depth of catheter into patient`s airway and correct tracheal position of replacement endotracheal tube.Markers on the cook airway exchange catheter refer to distance from tip of catheter.Catheter and endotracheal tube should not be advanced beyond the carina.To avoid barotrauma, ensure that the tip of the cae catheter is always above the carina, preferably 2-3cm.Potential adverse events: barotrauma , perforation of the bronchi or lung parenchyma.Endotracheal tube exchange: 1.Before advancing the cook airway exchange (cae) catheter into the endotracheal tube to be replaced, confirm correct endotracheal tube position.2.Using the outer margin of the patient`s mouth or nasal orifice as a landmark, note the marking on the endotracheal tube.A piece of tape or other marker may be placed on the cae catheter at the corresponding distance from the tip to aid in correct placement within the endotracheal tube.Caution: to avoid barotrauma, ensure that the tip of the cae catheter is always above the carina, preferably 2-3 cm.Note: if a high pressure oxypen source is used for insufflation (e.G.Jet ventilator), begin at lower pressure and work up gradually.Rising chest wall, pulse oximetry and oral air flow should be carefully monitored." based on the information provided, no inspection of returned product and the results of the investigation, it was concluded the cause of this event to be the over-insertion of the cook airway exchange catheter during the procedure.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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