Organ Donation Survey Among Health Care Professionals in Argentina

NCT03458052 | Unknown DMC

• 1 other identifier: 3493
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to gather information about knowledge, professional experience and attitude toward organ donation among health care professionals involved in the care of potential donors about the procurement process and potential lung donor management nationwide.

Conditions

Brain Death; Lung Transplantation; Respiration, Artificial; Tissue and Organ Procurement

Keywords

Intensive and critical care; Organ donation; Knowledge

Outcome Measures

Primary Outcomes (26)

• Attitude Toward Organ Donation

  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

  investigated whether the health care professional is a registered organ donor: Yes:1, No:0.

  6 months

• Last will manifest

  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

  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

  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

  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

  investigated whether the health care professional received organ donation information during their degree formation: Yes:1, No:0.

  6 months

• Post degree formation

  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

  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

  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

  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

  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

  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

  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

  investigated whether the health care professional had ever done an apnea test during this professional career.

  6 months

• Type of apnea test

  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:

  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

  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

  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

  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

  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

  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

  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

  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

  investigated whether the health care professional use a closed-circuit for endotracheal suctioning.

  6 months

• Measures to prevent ventilator-associated pneumonia

  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

Eligibility Criteria

• Age: 23 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Heath Care Professionals working in Adult and Pediatric Critical Care Units and Emergency Department from Argentinian Public and Private Hospitals, registrated in the Sociedad Argentina de Terapia Intensiva

You may qualify if:

• 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.

You may not qualify if:

• unrelated to the care of neurocritical patients

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, 1414, Argentina

RECRUITING

Related Publications (22)

• 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.

  PMID: 24365763 RESULT

• 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.

  PMID: 18636057 RESULT

• 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.

  PMID: 23237700 RESULT

• 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.

  PMID: 19232208 RESULT

• 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.

  PMID: 12243491 RESULT

• 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.

  PMID: 16424709 RESULT

• 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.

  PMID: 21156950 RESULT

• 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.

  PMID: 25010954 RESULT

• 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.

  PMID: 22194439 RESULT

• 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.

  PMID: 25010965 RESULT

• 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.

  PMID: 24283226 RESULT

• 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.

  PMID: 24429157 RESULT

• 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.

  PMID: 22228421 RESULT

• 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.

  PMID: 23912380 RESULT

• 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.

  PMID: 16799075 RESULT

• Kirschbaum CE, Hudson S. Increasing organ yield through a lung management protocol. Prog Transplant. 2010 Mar;20(1):28-32. doi: 10.1177/152692481002000105.

  PMID: 20397343 RESULT

• 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.

  PMID: 22759403 RESULT

• 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.

  PMID: 10390410 RESULT

• 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.

  PMID: 19857731 RESULT

• 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.

  PMID: 21422364 RESULT

• 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.

  PMID: 22963221 RESULT

• 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.

  PMID: 24314951 RESULT

Related Links

• Alejandro Da Lozzo. Historia del trasplante pulmonar en el mundo y en la Argentina. Rev Hosp Ital. B.Aires 2013;33(3):111-119.
• Ruiz V. R., Da Lozzo A. G., Midley A. D. Optimización del Soporte Ventilatorio del Donante Pulmonar. Revisión Bibliográfica. RAMR 2017;2:174-179

MeSH Terms

Conditions

Brain Death; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Vanesa R Ruiz, RT

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanesa R Ruiz, RT

CONTACT

+54(011)4959 0200.; vanesa.ruiz@hospitalitaliano.org.ar

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 8, 2018
• Study Start: February 16, 2018
• Primary Completion: April 1, 2018
• Study Completion: September 1, 2018
• Last Updated: March 12, 2018

Record last verified: 2018-02

Locations

AR (1)