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Functional Endoscopic Evaluation vs Evan’s Blue Dye Test for Functional Endoscopic Evaluation vs Evan’s Blue Dye Test for Swallowing Assessment of Tracheostomised Patients Swallowing Assessment of Tracheostomised Patients Kynigou M . Kynigou M . 1 1 , Aggeli D. , Aggeli D. 1 1 , Stefanidis A. , Stefanidis A. 1 1 , Triaridis A , Triaridis A 1 1 ., Chatziavramidis A ., Chatziavramidis A 2 2 ., ., Thomaidis J Thomaidis J 1 1 1 1 ENT Dpt, ‘Theagenion’ Anti-cancer Hospital, Thessaloniki ENT Dpt, ‘Theagenion’ Anti-cancer Hospital, Thessaloniki 2 2 ENT Dpt, Papageorgiou General Hospital, Thessaloniki ENT Dpt, Papageorgiou General Hospital, Thessaloniki INTODUCTION-PURPOSE INTODUCTION-PURPOSE Tracheotomy is among the most commonly conducted procedures in critically ill patients. The Tracheotomy is among the most commonly conducted procedures in critically ill patients. The incidence of aspiration in patients with tracheotomy is 50-87% incidence of aspiration in patients with tracheotomy is 50-87% 1,2 1,2 . The Evans blue dye test for . The Evans blue dye test for aspiration in tracheotomised individuals was introduced by Cameron aspiration in tracheotomised individuals was introduced by Cameron 3 . The test is performed by . The test is performed by placing drops of Evans blue dye on the patient’s tongue. The modified Evans blue dye test placing drops of Evans blue dye on the patient’s tongue. The modified Evans blue dye test (MEBDT) introduces a slight variation on the original examination as described by Cameron. In (MEBDT) introduces a slight variation on the original examination as described by Cameron. In the MEBDT, the patient is given blue dyed food and liquids. the MEBDT, the patient is given blue dyed food and liquids. Since its introduction, almost 40 years ago, the blue dye test accuracy has been questioned. Since its introduction, almost 40 years ago, the blue dye test accuracy has been questioned. A new procedure has been recently introduced into the discipline of laryngology, using A new procedure has been recently introduced into the discipline of laryngology, using flexible endoscopy for assessing swallowing function: Fiberoptic Endoscopic Evaluation of flexible endoscopy for assessing swallowing function: Fiberoptic Endoscopic Evaluation of Swallowing (FEES). Swallowing (FEES). The purpose of our project is to correlate FEES with Evan’s blue dye test used for clinical The purpose of our project is to correlate FEES with Evan’s blue dye test used for clinical detection of aspiration in patients with tracheotomy. detection of aspiration in patients with tracheotomy. PATIENTS-METHOD PATIENTS-METHOD Forty-one individuals participated in this prospective study. They were tracheotomised Forty-one individuals participated in this prospective study. They were tracheotomised patients in the Intensive Care Unit (ICU). All patients, 1-3 days before being discharged patients in the Intensive Care Unit (ICU). All patients, 1-3 days before being discharged from ICU were checked with EBDT, MEBDT and FEES procedures. All procedures were conducted from ICU were checked with EBDT, MEBDT and FEES procedures. All procedures were conducted from the same laryngologist, with clinical and instrumental swallowing diagnostic experience. from the same laryngologist, with clinical and instrumental swallowing diagnostic experience. In EBDT, four drops of Evans blue dye were placed on the patient’s tongue and the trachea In EBDT, four drops of Evans blue dye were placed on the patient’s tongue and the trachea was suctioned at set intervals for coloured secretions. In MEBDT, different consistencies and was suctioned at set intervals for coloured secretions. In MEBDT, different consistencies and different amounts of coloured food were given to the patients. The presence of coloured different amounts of coloured food were given to the patients. The presence of coloured suctioned secretion suggested aspiration, i.e. a positive blue dye test, either EBDT or suctioned secretion suggested aspiration, i.e. a positive blue dye test, either EBDT or MEBDT. MEBDT. Within 24 hours the fiberoptic examination of swallowing (FEES) was administrated. Within 24 hours the fiberoptic examination of swallowing (FEES) was administrated. FEES FEES involves passing transnasally a fiberoptic laryngoscope in order to visualize the involves passing transnasally a fiberoptic laryngoscope in order to visualize the hypopharynx, larynx and proximal trachea for the purpose of assessing and treating swallowing hypopharynx, larynx and proximal trachea for the purpose of assessing and treating swallowing function. In this procedure, a teaspoonful of creamy colored food and 2 to 5 cc of colored function. In this procedure, a teaspoonful of creamy colored food and 2 to 5 cc of colored liquid are fed to the patient. liquid are fed to the patient. The endoscopic presence of dye below the level of the true The endoscopic presence of dye below the level of the true vocal cords signifies aspiration and positive FEES. vocal cords signifies aspiration and positive FEES. RESULTS RESULTS Purpose of this study was to correlate this new method (FEES) with the classic and modified Purpose of this study was to correlate this new method (FEES) with the classic and modified Evans blue dye test in 41 ICU tracheotomised patients. Evans blue dye test in 41 ICU tracheotomised patients. Aspiration was present in 37 of the 41 (90,2%) FEES studies while aspiration was absent in Aspiration was present in 37 of the 41 (90,2%) FEES studies while aspiration was absent in the other 4 FEES studies. Aspiration was present in 30 of the 41 (73,2%) MEBDT tests and the other 4 FEES studies. Aspiration was present in 30 of the 41 (73,2%) MEBDT tests and absent in the other 11 MEBDT tests. absent in the other 11 MEBDT tests. With FEES as the objective test of presence of aspiration, Evans blue dye test sensitivity With FEES as the objective test of presence of aspiration, Evans blue dye test sensitivity and specificity identifying aspiration was 78% and 75% respectively. and specificity identifying aspiration was 78% and 75% respectively. Positive prognostic value was 96, 6% and negative prognostic value was 27, 3%. Positive prognostic value was 96, 6% and negative prognostic value was 27, 3%. DISCUSSION-CONCLUSIONS DISCUSSION-CONCLUSIONS The limitations in swallowing function created by tracheostomy necessitate a high index of The limitations in swallowing function created by tracheostomy necessitate a high index of suspicion for aspiration to be maintained in all tracheotomised individuals. suspicion for aspiration to be maintained in all tracheotomised individuals. Evan’s blue dye (T-1824) is a diazo dye that has been used for determining the blood volume Evan’s blue dye (T-1824) is a diazo dye that has been used for determining the blood volume in humans and animals, named after Herbert McLean Evans, an American anatomist and in humans and animals, named after Herbert McLean Evans, an American anatomist and physiologist at the University of California who published blood volume studies physiologist at the University of California who published blood volume studies 4 The EBDT and MEBDT are low cost bedside methods, easy to administrate, with no need for The EBDT and MEBDT are low cost bedside methods, easy to administrate, with no need for special expertise in endoscopy or expensive endoscopic equipment. The last 40 years the special expertise in endoscopy or expensive endoscopic equipment. The last 40 years the accuracy of blue dye test in documenting aspiration has been questioned. Thompson-Henry accuracy of blue dye test in documenting aspiration has been questioned. Thompson-Henry 5 reported the failure of MEBDT in detecting aspiration in five individuals. Brady et al reported the failure of MEBDT in detecting aspiration in five individuals. Brady et al 6 6 and and Donzelli et al Donzelli et al 7 7 reported a 50% false-negative error rate for the detection of trace aspiration reported a 50% false-negative error rate for the detection of trace aspiration amounts. Winklmeier et al amounts. Winklmeier et al 8 8 reported 95.24% sensitivity and 100% specificity when they reported 95.24% sensitivity and 100% specificity when they performed MEBDT and FEES on thirty tracheotomised head and neck cancer patients. In our study performed MEBDT and FEES on thirty tracheotomised head and neck cancer patients. In our study the sensitivity and specificity of MEBDT in predicting aspiration was 78% and 75% the sensitivity and specificity of MEBDT in predicting aspiration was 78% and 75% respectively. We suggest that high positive prognostic value (96.6%), implies that when respectively. We suggest that high positive prognostic value (96.6%), implies that when positive, Evans blue dye test should be evaluated, but when negative, endoscopic examination positive, Evans blue dye test should be evaluated, but when negative, endoscopic examination of swallowing should be performed in order to confirm the prior result. False negative of swallowing should be performed in order to confirm the prior result. False negative results were present in our cohort in cases of laryngospasm, vocal cord paralysis and thick results were present in our cohort in cases of laryngospasm, vocal cord paralysis and thick tracheal secretions in the aditus. The presence of nasogastric tube, allowing leaking of food tracheal secretions in the aditus. The presence of nasogastric tube, allowing leaking of food around it into the larynx, was the only cause of false positive results. Fiberoptic around it into the larynx, was the only cause of false positive results. Fiberoptic Endoscopic Evaluation of Swallowing (FEES) is slightly invasive, easy to perform bedside Endoscopic Evaluation of Swallowing (FEES) is slightly invasive, easy to perform bedside procedure that can be easily repeated, gives us more accurate information and allows the procedure that can be easily repeated, gives us more accurate information and allows the clinician to identify the physiology of swallowing and determine the safe oral intake leading clinician to identify the physiology of swallowing and determine the safe oral intake leading to decannulation of the tracheostomised patients. to decannulation of the tracheostomised patients. LITERATURE LITERATURE 1. Elpern E, Scott M, Ries P, Plumonary a spiration in mechanically ventilated patients with tracheotomies. Chest 105:563-566, 1994 1. Elpern E, Scott M, Ries P, Plumonary a spiration in mechanically ventilated patients with tracheotomies. Chest 105:563-566, 1994 2. Pannunzio T Aspiration of oral feedings in patients with tracheotomies. AACN Clin Issues 7:560-569, 1996 2. Pannunzio T Aspiration of oral feedings in patients with tracheotomies. AACN Clin Issues 7:560-569, 1996 3. Cameron J, Reynolds J, Zuidema G Aspiration in patients with tracheotomies. Surg Gynacol Obstet 136:60-70, 1973 3. Cameron J, Reynolds J, Zuidema G Aspiration in patients with tracheotomies. Surg Gynacol Obstet 136:60-70, 1973 4. Dawson A, Evans H, Wipple G Blood volume studies: behaviour of large series of dyes introduced into circulating blood. Am J Physiol 4. Dawson A, Evans H, Wipple G Blood volume studies: behaviour of large series of dyes introduced into circulating blood. Am J Physiol 51:232, 1920 51:232, 1920 5. Thompson-Henry S, Braddock B. The modified Evan’s blue dye procedure fails to detect aspiration in the tracheostomized patient: five case 5. Thompson-Henry S, Braddock B. The modified Evan’s blue dye procedure fails to detect aspiration in the tracheostomized patient: five case reports. Dysphagia 10:172-174, 1995 reports. Dysphagia 10:172-174, 1995 6. Brady SL, et al. Simultaneous video- fluoroscopic swallow study and modified Evans blue dye procedure: an evaluation of blue dye 6. Brady SL, et al. Simultaneous video- fluoroscopic swallow study and modified Evans blue dye procedure: an evaluation of blue dye visualization in cases of known aspiration. Dysphagia 14:146-149, 1999 visualization in cases of known aspiration. Dysphagia 14:146-149, 1999 7. Donzelli G, et al. Simultaneous modified Evans blue dye procedure and video nasal endoscopic evaluation of the swallow. Laryngoscope 7. Donzelli G, et al. Simultaneous modified Evans blue dye procedure and video nasal endoscopic evaluation of the swallow. Laryngoscope 111:1746-1750, 2001 111:1746-1750, 2001 8. Winklmaier U, et al. The accuracy of the modified Evans blue dye test in detecting aspiration in head and neck cancer patients. Eur Arch 8. Winklmaier U, et al. The accuracy of the modified Evans blue dye test in detecting aspiration in head and neck cancer patients. Eur Arch Otorhinolaryngol 264:1059-1064, 2007 Otorhinolaryngol 264:1059-1064, 2007

Functional Endoscopic Evaluation vs Evan’s Blue Dye Test for Swallowing Assessment of Tracheostomised Patients Kynigou M. 1, Aggeli D. 1, Stefanidis A

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Functional Endoscopic Evaluation vs Evan’s Blue Dye Test for Functional Endoscopic Evaluation vs Evan’s Blue Dye Test for Swallowing Assessment of Tracheostomised PatientsSwallowing Assessment of Tracheostomised PatientsKynigou M .Kynigou M .11, Aggeli D., Aggeli D.11, Stefanidis A., Stefanidis A.11, Triaridis A, Triaridis A11., Chatziavramidis A., Chatziavramidis A22., Thomaidis J., Thomaidis J11

11 ENT Dpt, ‘Theagenion’ Anti-cancer Hospital, Thessaloniki ENT Dpt, ‘Theagenion’ Anti-cancer Hospital, Thessaloniki22 ENT Dpt, Papageorgiou General Hospital, Thessaloniki ENT Dpt, Papageorgiou General Hospital, Thessaloniki

INTODUCTION-PURPOSEINTODUCTION-PURPOSETracheotomy is among the most commonly conducted procedures in critically ill patients. The Tracheotomy is among the most commonly conducted procedures in critically ill patients. The incidence of aspiration in patients with tracheotomy is 50-87%incidence of aspiration in patients with tracheotomy is 50-87%1,21,2 . The Evans blue dye test for aspiration . The Evans blue dye test for aspiration in tracheotomised individuals was introduced by Cameronin tracheotomised individuals was introduced by Cameron33. The test is performed by placing drops of . The test is performed by placing drops of Evans blue dye on the patient’s tongue. The modified Evans blue dye test (MEBDT) introduces a slight Evans blue dye on the patient’s tongue. The modified Evans blue dye test (MEBDT) introduces a slight variation on the original examination as described by Cameron. In the MEBDT, the patient is given blue variation on the original examination as described by Cameron. In the MEBDT, the patient is given blue dyed food and liquids.dyed food and liquids.Since its introduction, almost 40 years ago, the blue dye test accuracy has been questioned. A new Since its introduction, almost 40 years ago, the blue dye test accuracy has been questioned. A new procedure has been recently introduced into the discipline of laryngology, using flexible endoscopy for procedure has been recently introduced into the discipline of laryngology, using flexible endoscopy for assessing swallowing function: Fiberoptic Endoscopic Evaluation of Swallowing (FEES).assessing swallowing function: Fiberoptic Endoscopic Evaluation of Swallowing (FEES). The purpose of our project is to correlate FEES with Evan’s blue dye test used for clinical detection of The purpose of our project is to correlate FEES with Evan’s blue dye test used for clinical detection of aspiration in patients with tracheotomy. aspiration in patients with tracheotomy.

PATIENTS-METHOD PATIENTS-METHOD Forty-one individuals participated in this prospective study. They were tracheotomised patients in the Forty-one individuals participated in this prospective study. They were tracheotomised patients in the Intensive Care Unit (ICU). All patients, 1-3 days before being discharged from ICU were checked with Intensive Care Unit (ICU). All patients, 1-3 days before being discharged from ICU were checked with EBDT, MEBDT and FEES procedures. All procedures were conducted from the same laryngologist, with EBDT, MEBDT and FEES procedures. All procedures were conducted from the same laryngologist, with clinical and instrumental swallowing diagnostic experience.clinical and instrumental swallowing diagnostic experience. In EBDT, four drops of Evans blue dye were placed on the patient’s tongue and the trachea was In EBDT, four drops of Evans blue dye were placed on the patient’s tongue and the trachea was suctioned at set intervals for coloured secretions. In MEBDT, different consistencies and different suctioned at set intervals for coloured secretions. In MEBDT, different consistencies and different amounts of coloured food were given to the patients. The presence of coloured suctioned secretion amounts of coloured food were given to the patients. The presence of coloured suctioned secretion suggested aspiration, i.e. a positive blue dye test, either EBDT or MEBDT.suggested aspiration, i.e. a positive blue dye test, either EBDT or MEBDT.Within 24 hours the fiberoptic examination of swallowing (FEES) was administrated. Within 24 hours the fiberoptic examination of swallowing (FEES) was administrated. FEES involves FEES involves passing transnasally a fiberoptic laryngoscope in order to visualize the hypopharynx, larynx and passing transnasally a fiberoptic laryngoscope in order to visualize the hypopharynx, larynx and proximal trachea for the purpose of assessing and treating swallowing function. In this procedure, a proximal trachea for the purpose of assessing and treating swallowing function. In this procedure, a teaspoonful of creamy colored food and 2 to 5 cc of colored liquid are fed to the patient.teaspoonful of creamy colored food and 2 to 5 cc of colored liquid are fed to the patient.The endoscopic The endoscopic presence of dye below the level of the true vocal cords signifies aspiration and positive FEES.presence of dye below the level of the true vocal cords signifies aspiration and positive FEES.

RESULTS RESULTS Purpose of this study was to correlate this new method (FEES) with the classic and modified Evans Purpose of this study was to correlate this new method (FEES) with the classic and modified Evans blue dye test in 41 ICU tracheotomised patients.blue dye test in 41 ICU tracheotomised patients.Aspiration was present in 37 of the 41 (90,2%) FEES studies while aspiration was absent in the other 4 Aspiration was present in 37 of the 41 (90,2%) FEES studies while aspiration was absent in the other 4 FEES studies. Aspiration was present in 30 of the 41 (73,2%) MEBDT tests and absent in the other 11 FEES studies. Aspiration was present in 30 of the 41 (73,2%) MEBDT tests and absent in the other 11 MEBDT tests. MEBDT tests. With FEES as the objective test of presence of aspiration, Evans blue dye test sensitivity and specificity With FEES as the objective test of presence of aspiration, Evans blue dye test sensitivity and specificity identifying aspiration was 78% and 75% respectively. identifying aspiration was 78% and 75% respectively. Positive prognostic value was 96, 6% and negative prognostic value was 27, 3%. Positive prognostic value was 96, 6% and negative prognostic value was 27, 3%.

DISCUSSION-CONCLUSIONSDISCUSSION-CONCLUSIONSThe limitations in swallowing function created by tracheostomy necessitate a high index of suspicion The limitations in swallowing function created by tracheostomy necessitate a high index of suspicion for aspiration to be maintained in all tracheotomised individuals. for aspiration to be maintained in all tracheotomised individuals. Evan’s blue dye (T-1824) is a diazo dye that has been used for determining the blood volume in Evan’s blue dye (T-1824) is a diazo dye that has been used for determining the blood volume in humans and animals, named after Herbert McLean Evans, an American anatomist and physiologist at humans and animals, named after Herbert McLean Evans, an American anatomist and physiologist at the University of California who published blood volume studiesthe University of California who published blood volume studies44

The EBDT and MEBDT are low cost bedside methods, easy to administrate, with no need for special The EBDT and MEBDT are low cost bedside methods, easy to administrate, with no need for special expertise in endoscopy or expensive endoscopic equipment. The last 40 years the accuracy of blue dye expertise in endoscopy or expensive endoscopic equipment. The last 40 years the accuracy of blue dye test in documenting aspiration has been questioned. Thompson-Henrytest in documenting aspiration has been questioned. Thompson-Henry55 reported the failure of MEBDT reported the failure of MEBDT in detecting aspiration in five individuals. Brady et alin detecting aspiration in five individuals. Brady et al6 6 and Donzelli et aland Donzelli et al7 7 reported a 50% false-negative reported a 50% false-negative error rate for the detection of trace aspiration amounts. Winklmeier et alerror rate for the detection of trace aspiration amounts. Winklmeier et al8 8 reported 95.24% sensitivity reported 95.24% sensitivity and 100% specificity when they performed MEBDT and FEES on thirty tracheotomised head and neck and 100% specificity when they performed MEBDT and FEES on thirty tracheotomised head and neck cancer patients. In our study the sensitivity and specificity of MEBDT in predicting aspiration was 78% cancer patients. In our study the sensitivity and specificity of MEBDT in predicting aspiration was 78% and 75% respectively. We suggest that high positive prognostic value (96.6%), implies that when and 75% respectively. We suggest that high positive prognostic value (96.6%), implies that when positive, Evans blue dye test should be evaluated, but when negative, endoscopic examination of positive, Evans blue dye test should be evaluated, but when negative, endoscopic examination of swallowing should be performed in order to confirm the prior result. False negative results were swallowing should be performed in order to confirm the prior result. False negative results were present in our cohort in cases of laryngospasm, vocal cord paralysis and thick tracheal secretions in present in our cohort in cases of laryngospasm, vocal cord paralysis and thick tracheal secretions in the aditus. The presence of nasogastric tube, allowing leaking of food around it into the larynx, was the the aditus. The presence of nasogastric tube, allowing leaking of food around it into the larynx, was the only cause of false positive results. Fiberoptic Endoscopic Evaluation of Swallowing (FEES) is slightly only cause of false positive results. Fiberoptic Endoscopic Evaluation of Swallowing (FEES) is slightly invasive, easy to perform bedside procedure that can be easily repeated, gives us more accurate invasive, easy to perform bedside procedure that can be easily repeated, gives us more accurate information and allows the clinician to identify the physiology of swallowing and determine the safe oral information and allows the clinician to identify the physiology of swallowing and determine the safe oral intake leading to decannulation of the tracheostomised patients. intake leading to decannulation of the tracheostomised patients.

LITERATURELITERATURE1. Elpern E, Scott M, Ries P, Plumonary a spiration in mechanically ventilated patients with tracheotomies. Chest 105:563-566, 1994 1. Elpern E, Scott M, Ries P, Plumonary a spiration in mechanically ventilated patients with tracheotomies. Chest 105:563-566, 1994 2. Pannunzio T Aspiration of oral feedings in patients with tracheotomies. AACN Clin Issues 7:560-569, 19962. Pannunzio T Aspiration of oral feedings in patients with tracheotomies. AACN Clin Issues 7:560-569, 19963. Cameron J, Reynolds J, Zuidema G Aspiration in patients with tracheotomies. Surg Gynacol Obstet 136:60-70, 19733. Cameron J, Reynolds J, Zuidema G Aspiration in patients with tracheotomies. Surg Gynacol Obstet 136:60-70, 19734. Dawson A, Evans H, Wipple G Blood volume studies: behaviour of large series of dyes introduced into circulating blood. Am J Physiol 51:232, 19204. Dawson A, Evans H, Wipple G Blood volume studies: behaviour of large series of dyes introduced into circulating blood. Am J Physiol 51:232, 19205. Thompson-Henry S, Braddock B. The modified Evan’s blue dye procedure fails to detect aspiration in the tracheostomized patient: five case reports. 5. Thompson-Henry S, Braddock B. The modified Evan’s blue dye procedure fails to detect aspiration in the tracheostomized patient: five case reports. Dysphagia 10:172-174, 1995Dysphagia 10:172-174, 19956. Brady SL, et al. Simultaneous video- fluoroscopic swallow study and modified Evans blue dye procedure: an evaluation of blue dye visualization in 6. Brady SL, et al. Simultaneous video- fluoroscopic swallow study and modified Evans blue dye procedure: an evaluation of blue dye visualization in cases of known aspiration. Dysphagia 14:146-149, 1999cases of known aspiration. Dysphagia 14:146-149, 19997. Donzelli G, et al. Simultaneous modified Evans blue dye procedure and video nasal endoscopic evaluation of the swallow. Laryngoscope 111:1746-1750, 7. Donzelli G, et al. Simultaneous modified Evans blue dye procedure and video nasal endoscopic evaluation of the swallow. Laryngoscope 111:1746-1750, 200120018. Winklmaier U, et al. The accuracy of the modified Evans blue dye test in detecting aspiration in head and neck cancer patients. Eur Arch 8. Winklmaier U, et al. The accuracy of the modified Evans blue dye test in detecting aspiration in head and neck cancer patients. Eur Arch Otorhinolaryngol 264:1059-1064, 2007 Otorhinolaryngol 264:1059-1064, 2007