- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03458052
Organ Donation Survey Among Health Care Professionals in Argentina
Knowledge, Professional Experience and Attitude Toward Organ Donation Among Health Care Professionals in Argentina: the DonAR Survey
Study Overview
Status
Detailed Description
The shortage of cadaveric organ donors for transplantation is a global problem. This fact prolongs the time on the waiting list and, therefore, the mortality, which rise to 21.15% in Argentina compared to a world average of 16%. Many reasons can explain the low procurement rate. It has been stated that the conventional ventilatory management for potential lung donors is suboptimal for lung preservation before harvest.
In Argentina there is limited research regarding the attitude toward organ donation among health care professionals, knowledge of the federal organ procurement program and professional experience in diagnosing brain death and lung donor management. Knowing the Argentinian current situation will make it possible to detect possible organ shortages causes, evaluate strategies to increase the national procurement rate and to instruct the health team that assists neurocritical patients who die of brain death. So we propose the following research.
The aim of this study is to gather information about knowledge, professional experience and attitude among health care professionals involved in the care of potential donors toward organ donation, procurement process and potential lung donor management nationwide.
A online questionnaire was designed and distributed among health care professionals register to different scientific societies related to the care of neurocritical patients between febrary 16th and september 1st. The questionnaire consisting of 37 ítems: 6 items measuring attitudes, 6 items measuring knowledge, 16 items investigating professional experience and 9 ítems assessing demographics.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Vanesa R Ruiz, RT
- Phone Number: 5770 +54(011)4959 0200.
- Email: vanesa.ruiz@hospitalitaliano.org.ar
Study Locations
-
-
-
Buenos Aires, Argentina, 1414
- Recruiting
- Hospital Italiano de Buenos Aires
-
Contact:
- Vanesa R Ruiz, RT
- Phone Number: 5770 +54(011)4959 0200.
- Email: vanesa.ruiz@hospitalitaliano.org.ar
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- health care professionals
- register to the Sociedad Argentina de Terapia Intensiva (SATI)
- related to the care of neurocritical patients
- between febrary 16th and september 1st.
Exclusion Criteria:
- unrelated to the care of neurocritical patients
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attitude Toward Organ Donation
Time Frame: 6 months
|
investigated attitudes regarding organ donation among health care professional: is an organ donor:1, isn´t an organ donor:2, he/she haven´t been decided: 2
|
6 months
|
Organ Donor Registry
Time Frame: 6 months
|
investigated whether the health care professional is a registered organ donor: Yes:1, No:0.
|
6 months
|
Last will manifest
Time Frame: 6 months
|
investigated whether the health care professional´s spouse and / or family knows he/she organ donor attitude towards organ donation: Yes:1, No:0.
|
6 months
|
Reasons to donate
Time Frame: 6 months
|
investigated reasons why the health care professional´ would donate their organs: To save the life of another person: 1, Because after death the body does not need anything: 2, To create awareness in the donation: 3, For religious reasons: 4, Others: 5
|
6 months
|
Reasons not to donate
Time Frame: 6 months
|
investigated reasons why the health care professional´ would not donate their organs or haven´t decided: for religious aspects: 1, for the improper organs use: 2, to maintain my body integrity: 3, for fear of the removal of organs before my death: 4, for fear that they do not give me the attention Medical needed to save my life: 5, Others: 6
|
6 months
|
Level of knowledge
Time Frame: 6 months
|
investigated how the health care professional would classify the level of knowledge regarding organ donation: Not at all informed: 1, Little informed: 2, Suitably informed: 3
|
6 months
|
Degree formation
Time Frame: 6 months
|
investigated whether the health care professional received organ donation information during their degree formation: Yes:1, No:0.
|
6 months
|
Post degree formation
Time Frame: 6 months
|
investigated whether the health care professional attended to courses on procurement or organ donation after their degree formation: Yes:1, No:0.
|
6 months
|
Brain death definition
Time Frame: 6 months
|
investigated when health care professional consider a neurocritical patient as a potential organ donor: When the patient is in a coma: 1, When brain inactivity is corroborated with technical or instrumental means in a patient with irreversible absence of brain response with loss of consciousness, absence of spontaneous breathing, absence of cephalic reflexes and observation of fixed pupils: 2, When the patient is in a vegetative state: 3, When cardiorespiratory arrest occurs in the patient with irreversible absence of brain response with loss of consciousness, absence of spontaneous breathing, absence of cephalic reflexes and fixation of fixed pupils: 4, Other: 5
|
6 months
|
Lung organ donor criteria
Time Frame: 6 months
|
investigated whether the health care professional know the criteria the organ donor must meet to be considered an optimal lung donor.
PaO2 / FiO2> 300 with FiO2 1 and PEEP 10cmH2O, without evidence of aspiration / sepsis, absence of microorganism in sputum / BAL, absence of purulent secretions in tube: 1, X-ray with minimal infiltrates, no evidence of aspiration / sepsis, no history of cardiopulmonary surgery, absence of microorganism in sputum / BAL, absence of secretions: 2, clean chest X-ray, PaO2 / FiO2> 300 with FiO2 1 and PEEP 5cmH2O, absence of thoracic trauma, without evidence of aspiration / sepsis, no history of cardiopulmonary surgery, absence of microorganism in sputum / BAL, absence of purulent secretions in tube: 3, d.
Unilateral thoracic trauma, with no evidence of aspiration / sepsis, no history of cardiopulmonary surgery, absence of microorganism in sputum / BAL, absence of purulent secretions in tube: 4
|
6 months
|
Organ Donor Consent
Time Frame: 6 months
|
investigated whether the health care professional knows where and how to express he/she consent for organ donation: Yes:1, No:0.
|
6 months
|
Potential lung donor management protocols
Time Frame: 6 months
|
investigated whether the health care professional knows if the health care institution were he/she works have a potential lung donor management protocol.
|
6 months
|
Neurocritical patients care
Time Frame: 6 months
|
investigated whether the health care professional had ever assist a neurocritical patients during this professional career.
|
6 months
|
Call to the federal organ procurement organism to report a patients with a GCS ≤ 7
Time Frame: 6 months
|
investigated whether the health care professional had ever call to the federal organ procurement organism (INCUCAI) to report a neurocritical patients with a GCS ≤ 7.
|
6 months
|
Apnea Test
Time Frame: 6 months
|
investigated whether the health care professional had ever done an apnea test during this professional career.
|
6 months
|
Type of apnea test
Time Frame: 6 months
|
investigated which type of apnea test the health care professional had done: the conventional apnea test consisting in preoxygenation and disconnection form the ventilator; or one of the alternative apnea test: by artificial increase of Co2; with CPAP or by controlled hypoventilation.
|
6 months
|
Call to the federal organ procurement organism to report a possible brain death patient:
Time Frame: 6 months
|
investigated whether the health care professional had ever call to the federal organ procurement organism (INCUCAI) to report a possible brain death patient.
|
6 months
|
Potential organ donor patients care
Time Frame: 6 months
|
investigated whether the health care professional had ever participated in the procurement process and maintenance (management) of a potential organ donor patient during this professional career.
|
6 months
|
Change in ventilator parameters
Time Frame: 6 months
|
investigated whether the health care professional make a change in the ventilator parameters after the brain dead diagnosis.
|
6 months
|
Change in the fraction inspired oxygen
Time Frame: 6 months
|
investigated whether the health care professional change the fraction inspired oxygen to 100% after the brain dead diagnosis, or reduced it if the potential lung donor have a PaO2/FiO2 > 300.
|
6 months
|
Ventilator parameters
Time Frame: 6 months
|
investigated which tidal volume (Vt) and positive end expiratory pressure (PEEP) does the health care professional use to ventilate a potential lung donor patient among different options: Vt 10-12 mL/kg, PEEP 5 cmH20:1, Vt 10-12 mL/kg, PEEP 8-10 cmH20:2, Vt 8-10 mL/kg, PEEP 5 cmH20:3, Vt 8-10 mL/kg, PEEP 8-10 cmH20:4, Vt 6-8 mL/kg, PEEP 5 cmH20:5, Vt 6-8 mL/kg, PEEP 8-10cmH20:6, Other:7
|
6 months
|
Strategies to improve oxygenation
Time Frame: 6 months
|
investigated whether the health care professional use any strategy to improve oxygenation in case of low oxygenation and which type of strategies does it use: change positioning:1, pulmonary expansion techniques:2, endotracheal suctioning:3, Fiberoptic bronchoscopy:4, Recruitment maneuvers: 5, PEEP titulation:6, Others:7
|
6 months
|
Type of Recruitment maneuver
Time Frame: 6 months
|
investigated the most commonly used type of recruitment maneuver in a potential PULMONARY donor: Sighs with increased Tidal Volume for several breaths: 1, CPAP of 40 cmH20 for 40 seconds: 2, CPAP of 30 cmH20 for 30 seconds: 3, Step increase of PEEP to 40 cmH20 and then stepwise decrease: 4, PC Mode CMV with inspiratory pressure of 25-30 cmH20 and PEEP 10-15 cmH20 for 2 hours for a single time: 5, PC-CMV mode with inspiratory pressure of 20 cmH20 and stepwise increase of PEEP to 20-30 cmH20: 6, PEEP of 18-20 cmH20 for 1 minute, then decrease PEEP and increase Tidal Volume for several breaths: 7, Other: 8.
|
6 months
|
Type of PEEP titulation
Time Frame: 6 months
|
PEEP / FiO2 Table (ARDS Network): 1, PEEP / Compliance Protocol: 2, Determination of the lower inflection point per Pressure / Volume curve: 3, Increase of the PEEP for Plateau Pressure <28 cmH20 (Express Protocol): 4, Guided by esophageal manometry: 5, Guided by pulmonary ultrasound: 6, Guided by volumetric capnography: 7, Other: 8
|
6 months
|
Use of a closed-circuit for endotracheal suctioning
Time Frame: 6 months
|
investigated whether the health care professional use a closed-circuit for endotracheal suctioning.
|
6 months
|
Measures to prevent ventilator-associated pneumonia
Time Frame: 6 months
|
investigated whether the health care professional consider important to continue the care bundle to prevent ventilator-associated pneumonia such as: head elevation, tracheal cuff control, oral hygiene, etc.
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Vanesa R Ruiz, RT, Hospital Italiano de Buenos Aires
Publications and helpful links
General Publications
- Minambres E, Coll E, Duerto J, Suberviola B, Mons R, Cifrian JM, Ballesteros MA. Effect of an intensive lung donor-management protocol on lung transplantation outcomes. J Heart Lung Transplant. 2014 Feb;33(2):178-84. doi: 10.1016/j.healun.2013.10.034. Epub 2013 Oct 25.
- Mascia L, Mastromauro I, Viberti S, Vincenzi M, Zanello M. Management to optimize organ procurement in brain dead donors. Minerva Anestesiol. 2009 Mar;75(3):125-33. Epub 2008 Jan 24.
- Valapour M, Paulson K, Smith JM, Hertz MI, Skeans MA, Heubner BM, Edwards LB, Snyder JJ, Israni AK, Kasiske BL. OPTN/SRTR 2011 Annual Data Report: lung. Am J Transplant. 2013 Jan;13 Suppl 1:149-77. doi: 10.1111/ajt.12024.
- Del Rio F, Escudero D, De La Calle B, Vidal FG, Paredes MV, Nunez JR. [Evaluation and maintenance of the lung donor]. Med Intensiva. 2009 Jan-Feb;33(1):40-9. doi: 10.1016/s0210-5691(09)70304-3. Spanish.
- Rosengard BR, Feng S, Alfrey EJ, Zaroff JG, Emond JC, Henry ML, Garrity ER, Roberts JP, Wynn JJ, Metzger RA, Freeman RB, Port FK, Merion RM, Love RB, Busuttil RW, Delmonico FL. Report of the Crystal City meeting to maximize the use of organs recovered from the cadaver donor. Am J Transplant. 2002 Sep;2(8):701-11. doi: 10.1034/j.1600-6143.2002.20804.x. No abstract available.
- Mascia L, Bosma K, Pasero D, Galli T, Cortese G, Donadio P, Bosco R. Ventilatory and hemodynamic management of potential organ donors: an observational survey. Crit Care Med. 2006 Feb;34(2):321-7; quiz 328. doi: 10.1097/01.ccm.0000196828.87358.6e.
- Mascia L, Pasero D, Slutsky AS, Arguis MJ, Berardino M, Grasso S, Munari M, Boifava S, Cornara G, Della Corte F, Vivaldi N, Malacarne P, Del Gaudio P, Livigni S, Zavala E, Filippini C, Martin EL, Donadio PP, Mastromauro I, Ranieri VM. Effect of a lung protective strategy for organ donors on eligibility and availability of lungs for transplantation: a randomized controlled trial. JAMA. 2010 Dec 15;304(23):2620-7. doi: 10.1001/jama.2010.1796.
- Klesney-Tait JA, Eberlein M. Lung protective ventilation in donors: an ounce of prevention. Chest. 2014 Jul;146(1):4-6. doi: 10.1378/chest.14-0163. No abstract available.
- McKeown DW, Bonser RS, Kellum JA. Management of the heartbeating brain-dead organ donor. Br J Anaesth. 2012 Jan;108 Suppl 1:i96-107. doi: 10.1093/bja/aer351.
- Bansal R, Esan A, Hess D, Angel LF, Levine SM, George T, Raoof S. Mechanical ventilatory support in potential lung donor patients. Chest. 2014 Jul;146(1):220-227. doi: 10.1378/chest.12-2745.
- Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. No abstract available. Erratum In: N Engl J Med. 2014 Apr 24;370(17):1668-9.
- Munshi L, Keshavjee S, Cypel M. Donor management and lung preservation for lung transplantation. Lancet Respir Med. 2013 Jun;1(4):318-28. doi: 10.1016/S2213-2600(12)70064-4. Epub 2013 Feb 20.
- Lucangelo U, Del Sorbo L, Boffini M, Ranieri VM. Protective ventilation for lung transplantation. Curr Opin Anaesthesiol. 2012 Apr;25(2):170-4. doi: 10.1097/ACO.0b013e32834fdb54.
- Al-Khafaji A, Murugan R, Kellum JA. What's new in organ donation: better care of the dead for the living. Intensive Care Med. 2013 Nov;39(11):2031-3. doi: 10.1007/s00134-013-3038-1. Epub 2013 Aug 3. No abstract available.
- Angel LF, Levine DJ, Restrepo MI, Johnson S, Sako E, Carpenter A, Calhoon J, Cornell JE, Adams SG, Chisholm GB, Nespral J, Roberson A, Levine SM. Impact of a lung transplantation donor-management protocol on lung donation and recipient outcomes. Am J Respir Crit Care Med. 2006 Sep 15;174(6):710-6. doi: 10.1164/rccm.200603-432OC. Epub 2006 Jun 23.
- Kirschbaum CE, Hudson S. Increasing organ yield through a lung management protocol. Prog Transplant. 2010 Mar;20(1):28-32. doi: 10.1177/152692481002000105.
- Paries M, Boccheciampe N, Raux M, Riou B, Langeron O, Nicolas-Robin A. Benefit of a single recruitment maneuver after an apnea test for the diagnosis of brain death. Crit Care. 2012 Jul 3;16(4):R116. doi: 10.1186/cc11408.
- Gabbay E, Williams TJ, Griffiths AP, Macfarlane LM, Kotsimbos TC, Esmore DS, Snell GI. Maximizing the utilization of donor organs offered for lung transplantation. Am J Respir Crit Care Med. 1999 Jul;160(1):265-71. doi: 10.1164/ajrccm.160.1.9811017.
- Noiseux N, Nguyen BK, Marsolais P, Dupont J, Simard L, Houde I, Lallier M, Langevin S, Cantin B, Ferraro P. Pulmonary recruitment protocol for organ donors: a new strategy to improve the rate of lung utilization. Transplant Proc. 2009 Oct;41(8):3284-9. doi: 10.1016/j.transproceed.2009.08.041.
- Hanna K, Seder CW, Weinberger JB, Sills PA, Hagan M, Janczyk RJ. Airway pressure release ventilation and successful lung donation. Arch Surg. 2011 Mar;146(3):325-8. doi: 10.1001/archsurg.2011.35.
- Philpot SJ, Pilcher DV, Graham SM, Snell GI. Lung recruitment manoeuvres should be considered when assessing suitability for lung donation. Crit Care Resusc. 2012 Sep;14(3):244-5. No abstract available.
- Parto S, Shafaghi S, Khoddami-Vishteh HR, Makki SM, Abbasidezfuli A, Daneshvar A, Sheikhy K, Faeghi J, Ghorbani F, Parsa T, Najafizadeh K. Efficacy of recruitment maneuver for improving the brain dead marginal lungs to ideal. Transplant Proc. 2013;45(10):3531-3. doi: 10.1016/j.transproceed.2013.09.001.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3493
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Brain Death
-
Liu YonghongEnrolling by invitationSudden Unexpected Death in Epilepsy | Near-Sudden Unexpected Death in EpilepsyChina
-
Hospices Civils de LyonTerminatedSudden Unexpected Death in Epilepsy (SUDEP)France
-
Alexandria UniversityUnknownMaternal Death | Hypoxic Brain InjuryEgypt
-
NYU Langone HealthRecruiting
-
Centre Hospitalier Universitaire de NīmesTerminatedStress Disorders, Post-TraumaticFrance
-
Brigham and Women's HospitalNot yet recruitingEpilepsyUnited States
-
Fundació Institut de Recerca de l'Hospital de la...UnknownBiomarkers | Cardiac Sudden Death | Hypoxia Brain | Cell Membrane MicroparticlesSpain
-
Indiana UniversityGreenwich Biosciences; Child Neurology FoundationCompleted
-
Instituto de Investigación Hospital Universitario...Hospital de Santa Maria, PortugalCompletedPrevention of Kidney Injury Associated With Brain DeathSpain, Portugal
-
Gorm GreisenCopenhagen Trial Unit, Center for Clinical Intervention Research; Elsass FoundationCompletedBrain Injuries | Infant, Extremely Premature | Death; Neonatal | Death, BrainDenmark